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containment-isolators

Containment Isolators

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

Parenteral preparations refer to drugs using non-oral means of administration. Injectables, such as needles and syringes, are used to deliver a drug into the systemic circulation directly in the veins, muscles, under the skin, or in the tissue.

These parenteral formulations are pharmaceutical dosage forms that have strict regulations on being sterile, pyrogen-free, and free from visible particulate matter including reconstituted sterile powders. Solutions, suspensions, emulsions, and gels with APIs intended for administration by injection are usually supplied in vials, ampoules, pre-filled syringes, or pens to facilitate ease of use.

Injectables

<p class="filterable-grid__description">Liquid dosage forms are designed for easy absorption. The body quickly carries the active ingredients through the system and triggers the required response. But the greatest advantage of this medicinal type is its flexibility in formulation and dispensation. From lotions and syrups to drops and sprays, liquid solutions can be adapted to different administration routes including parenteral, topical, and oral. The fundamental liquid dosage manufacturing process involves dissolving or suspending solutes in a fluid. But that is not enough. A precise blend of excipients is needed to make the medicine go down.</p>

Liquid dosage forms

Pharmaceutical developments walk side by side with health advances to provide new medicines, treatments, and therapies that have increased life quality and extended life expectancy by years. Pharmaceutical manufacturing equipment helps deliver products to a great deal of the population, but there’s a significant share that doesn’t benefit from them yet. Over 2 billion people cannot get the medicines they need, according to the United Nations Industrial Development Organization, and local production might be a way to provide for these people.

Pharmaceuticals

Healthcare products are goods or services used to improve, maintain or prevent the deterioration of health or ease the consequences of illness. Healthcare products include a wide range of goods, from hospital clothing, over plasters, wound care products and diagnostic devices. These products must be clean and contamination-free, which is achieved with strictly regulated healthcare equipment.

Healthcare products

Barrier isolator systems create a physical and an aerodynamic barrier between the operator and the work process. The product or process inside the isolator can only be manipulated through the use of gloves or a robotic arm. Choosing an isolation system involves considering the safety regulations (for example; operator protection or cGMP standards), positive or negative pressure specifications, and monitoring and control requirements. Barrier and isolator systems are used in the pharmaceutical industry for sterile processes such as injectable drug filling and cytotoxic drug compounding. Barrier systems and isolators are integrated into full production lines and the most important thing is to control and monitor airflow.

Continuous

Industrial

In the pharmaceutical and cosmetic industries, viscous media such as gels, creams, and ointments can be difficult to recover from pipelines after transfer, leading to product loss and increased waste treatment costs.
<h2>Recover high-value residual products</h2>
The SteriPig Product Recovery System from INOXPA is designed to efficiently recover residual high-value products from pipelines while ensuring hygienic conditions. This system operates by utilizing a sphere (PIG) driven by compressed air to clear the pipeline, which is then prepared for Cleaning-In-Place (CIP). Conforming to EHEDG specifications, it includes a launcher, receiver, automatic butterfly valves, and position detectors. With metal components made of AISI 316L and a hygienic design with an internal surface finish of Ra ≤ 0.5 µm, this system is suitable for applications involving viscous media. It supports connections of different types, including DIN and SMS, and offers various levels of automation and control panel options.

Hygienic pipeline product recovery system

Industrial cleaning equipment is used to wash or disinfect machinery and the production/warehouse area. It may also be used to sterilize the product, equipment, tools, floor or work surfaces and to purify or clean the product by removing impurities. Choosing a suitable cleaning system depends on the type of product or equipment to be cleaned, the sensitivity of the product to heat, pressure, and chemicals, and the level of sterility desired.

Cleaning

Purification is the removal of contaminating substances and by-products to increase the level of purity of the desired substance. Considerations for choosing a suitable purification system in the industry, include the physical state of the mixture, the desired product, required level of purity, the type of mixture, heat sensitivity of the product, number of purification steps needed, and the production volume. Industrial purification systems are used for the production of pure water in the food pharmaceutical and biotech industries.

Purification

Recovery

liquid

Batch

Pilot

When working with highly potent active ingredients (HAPI), maintaining safety and containment is critical. A solution is needed to handle R&D applications and pilot batches while protecting both operators and the environment from exposure to hazardous substances.
<h2>Ensure operator safety and environmental protection</h2>
The PREXIMA THC by IMA is a tablet press designed for total high containment, suitable for R&D applications, pilot batches, and production support. The PREXIMA THC features sealed doors, limited contact surfaces, and negative pressure inside the processing area, ensuring safety and containment. It includes a turret of 8 stations (4B + 4D) and provides pre-compression and main compression forces similar to production machines, offering scalability. Operator access to the internal parts is facilitated via glove ports, enhancing safety. The machine configuration is flexible and allows for easy integration with existing solid dose processing lines. Equipped with IMA’s MAX HMI, it offers improved operator efficiency, prompt responsiveness, and easy learning.

Tablet press for high containment environments

Compaction machines and technologies crush or compress materials and make them denser. Compaction can be used to simply save space or to shape materials into a desired form or format. Tablets, pellets, or briquets are formed by compactors but powder presses also help form cosmetic eyeshadow or face powder.

Compaction

Compression

solid

In the pharmaceutical sector, protecting products from contamination due to personnel or environmental factors is crucial. The key challenge in aseptic processes is minimizing contamination risk to ensure product safety.
<h2>Minimize contamination risk in aseptic processes.</h2>
The Isolation Technology solutions from IMA are designed to address the need for minimal human intervention in aseptic fill-finish lines, ensuring higher sterility levels and improved operator safety. IMA Life's technology integrates automated filling systems for liquids or powders, effectively reducing the risk of cross-contamination. The system features a double-wall design with no external recirculation channels and a flush design for enhanced containment. HVAC systems are customized, flexible, and modular, tailored to fit specific needs. Advanced filtration and glove handling ergonomics further bolster the containment measures. Sensors are installed to monitor ventilation and electrical consumption, optimizing performance while reducing environmental impact. This isolation technology is suitable for the pharmaceutical industry, particularly in handling potent and cytotoxic compounds.

Isolation solutions for aseptic fill-finish lines

Filling lines are used extensively in all industries, such as food, pharmaceutical, chemical, and cosmetics, to accurately package different products into a container suitable for that product. Although the filling process is at the very end of the production line, it is no less important than the earlier steps. Last but not least, the idiom that dates back to 1382 when John Wyclif wrote the firste the laste, and the laste the firste, indicates just that the last things on a list are just as valuable as the previous ones. In this case, this idiom fits perfectly.

Filling

Complex processes call for continuous tracking and monitoring systems that help you to keep the manufacturing operation under control. The technology analyzes the components in the production phase for divergence in behavior or changes in conditions. Based on advanced software applications, monitoring platforms make sure that your products satisfy the quality criteria while they are being developed.

Monitoring

In the pharmaceutical industry, maintaining sterility and achieving high throughput during the fill-finish stages are crucial. Processing challenges often arise, such as managing different container types and ensuring precise, contamination-free handling.
<h2>Enhance aseptic processing capabilities</h2>
The INJECTA 36 by IMA is a high-speed fill-finish system designed to handle Ready-To-Use (RTU) components like syringes, vials, and pre-capped cartridges with advanced robotic technology. Capable of processing up to 36,000 components per hour, the system combines precision, reliability, and flexibility. Specialized robots perform all handling tasks without glass-to-glass contact or operator intervention, reducing validation times and enhancing multi-product manufacturing agility. The INJECTA 36 also features fully robotized check-weighing, automatic calibration of weight cells, and options for downstream connections such as de-nesting and automatic inspection. It's ideal for various containment solutions and isolation technologies, ensuring high-quality and efficient fill-finish processes in pharmaceutical manufacturing.

High-speed fill-finish system for ready-to-use components

Industrial inspection equipment is used for checking compliance with health, safety, and quality control standards. For that reason, inspection systems are most commonly utilized in the food and pharmaceutical industry but, they are also used in other industries too. Inspection solutions are often integrated into a production process or production line. Visual inspection systems perform checks to detect variation in size, shape, and color and ensure the presence of labels and closures. Check-weigh systems help ensure that product packages are not under or over-filled. Metal detection systems can help guard against the presence of foreign objects in product containers and X-ray inspection equipment is used to detect physical defects and to ensure high quality package seal integrity.

Inspection

Weighing

Ensuring sterility in pharmaceutical operations is paramount, especially during the handling of primary packages in aseptic conditions. Traditional manual operations can increase the risk of contamination and variation in processing times.
<h2>Automate sterile package opening and de-lidding</h2>
The IMA Robotic Sterile Package Opening System is designed to enhance aseptic processing by automating the opening and de-lidding of sterile primary packages. Utilizing advanced robotic technology, this system handles both single and double-bagged packages with precision. Outer and inner bags are opened using a robotic cutting arm and pincer device, reducing cross-contamination risks. After cutting, packages are transferred to an isolated area for de-lidding. This system complies with Annex 1 guidelines, ensuring that package flaps are only opened within a Restricted Barrier System (RABS). Suitable for medium to high production levels, the IMA system helps maintain sterility while minimizing manual intervention.

Robotic sterile package opening system

Cutting

Handling

In industries like pharmaceuticals, chemicals, and nuclear energy, handling hazardous materials safely and efficiently is crucial to ensure operational safety and compliance with regulatory standards. Poor containment can lead to contamination, health risks, and interruptions in production work flows.
<h2>Control hazardous material exposure</h2>
The containment and isolation solutions from Hosokawa Micron Ltd. are engineered to meet the highest industry standards for safely managing hazardous materials. Known for their robust design and build quality, these systems include bespoke isolators, gloveboxes, downflow booths, laminar flow cabinets, and filling and weighing systems. They offer reliable performance and sophisticated process integration capabilities backed by decades of processing expertise. These solutions are vital for pharmaceutical, chemical, and nuclear industries where maintaining low occupational exposure limits (OEL) is critical. Hosokawa’s containment systems ensure safe and sterile operations by integrating the latest technology and complying with stringent safety regulations.

Containment solutions for hazardous material processing

Powder

In environments where the handling of hazardous or sensitive materials is critical, maintaining a controlled environment is essential. Contamination during the sampling, discharging, or packaging processes can compromise both operator safety and product integrity.
<h2>Ensures safe and contamination-free material handling</h2>
The containment system, developed by Comber under Heinkel, is used with Nutsche filter dryers. This system enables protected sampling, product discharge, packaging, and disposal of residual materials without exposing operators to harmful substances or risking product contamination. The system features an isolator (or glove box) connected via a flange to the filter dryer’s discharge stopper. This ensures that the materials handled remain enclosed, minimizing exposure and contamination risks. It is ideal for industries such as pharmaceuticals, chemicals, and fine chemicals where safety and purity are paramount. By incorporating this containment solution, facilities can achieve regulatory compliance, improve product yields, and ensure the safety of their staff.

Containment system for filter dryers

Discharging

Packaging

Industrial sampling equipment are systems that allow manufacturers to test (in other words to take a sample of) the products they are manufacturing. This process is generally implemented as a means of quality control but it can also be used as a mean to ensure that production processes adhere to certain regulatory standards. Quality control in your manufacturing process starts with precision sampling techniques. Automated systems deliver consistent samples at a pre-set rate for accurate testing and probing. Sampling technology uses a calibration system involving a series of sensors to extract the material at high levels of reliability.

Sampling

When transferring powders in an industrial setting, creating a dust-tight seal is crucial to maintain cleanliness and prevent contamination during the charging or discharging process.
<h2>Ensure dust-tight transfer and containment</h2>
The Hanningfield Uni-Cap is a flexible silicone rubber seal designed for dust-tight transfer or containment of powders. The Uni-Cap can be adapted to various sizes and configurations, making it compatible with multiple types of process equipment, including mills, tablet presses, and vessels. The caps are available in several sizes, ranging from 2.5 inches to 16 inches in diameter, and are made from translucent FDA-compliant silicone. The Uni-Cap+ variant is fully transparent, offering excellent process visibility, which is particularly beneficial for monitoring powder flow and container fill levels. Both versions can be easily retrofitted to any process and come with stainless steel mounting rings for secure installation. The silicone used is platinum-cured, compliant with FDA standard 177.2600, and is also USP Class VI, TSE/BSE-free, ADI-free, and phthalates-free. For traceability, the manufacturing batch ID can be embossed onto the caps. Hanningfield Process Systems manufactures these caps in Great Britain.

Silicone dust caps for dust-tight powder transfer

Ensuring the sterility of drugs, components, and devices is critical before their release to patients. Traditional cleanrooms can be complex and require rigorous maintenance to prevent contamination, posing challenges for high productivity and reliable sterility testing.
<h2>Enables continuous sterility testing and reliable bio-decontamination</h2>
The Getinge ISOTEST isolator is designed to optimize sterility testing workflows for sterile drugs, components, and devices. This isolator provides a completely closed system that ensures a controlled sterile environment, reducing the risk of false-positive results. Unlike cleanrooms, the isolator offers a more manageable environment where contamination sources can be detected and controlled efficiently. It supports various sterility testing methods including closed or open membrane filtration, direct inoculation, and rapid microbiology methods. The dual-operator design increases productivity by allowing two users to work simultaneously. A single Siemens PLC control system validates and monitors critical parameters, ensuring traceability and integration with customer networks. Bio-decontamination cycles are short, facilitating up to 40 tests per 8-hour shift with rapid hydrogen peroxide vapor decontamination.

Sterility testing isolator for pharmaceutical labs

Bio-decontamination

Decontamination

Drawing samples and testing them for conformity with preset quality standards allows manufacturing units to produce a consistent quality of the product. In a batch process, sample testing systems ensures that each batch meets the specified standards. In a continuous process, product and materials testing helps in the early identification of quality issues, saving significant time and resources, and preventing a sub-standard product from reaching the market. The selection of industrial testing equipment depends on the identification of key quality parameters. These parameters may include volume, weight, viscosity, hardness, particle size distribution, sterility, gauge and containment, among other parameters. Testing machinery need regular calibration to ensure that the parameters being tested are accurate. Some of the more common testing solutions include thermal imagers, scratch testers, optical inspectors and texture analyzers.

Testing

When conducting aseptic processes such as sterile testing, small batch production, or compounding, contamination control is a critical challenge. Ensuring a sterile environment and maintaining traceable processes are essential to meet regulatory standards and prevent cross-contamination.
<h2>Enhances sterility with optimized process control</h2>
The ISOPRIME isolator by Getinge offers a cost-effective solution for various aseptic applications. Designed with a rigid-wall structure, it ensures continuous operations with a focus on traceability and compliance with FDA 21 CFR Part 11. The ISOPRIME is equipped with a Siemens HMI for user-friendly process control and monitoring. Operators benefit from easy access to the chamber and hatch due to the upwards-opening door, which frees up working space. Ventilation options include Unidirectional Airflow (UDAF) or Engineered Turbulent Flow (ETF), allowing the isolator to meet diverse aseptic process requirements. Additionally, the integrated Steritrace bio-decontamination unit ensures effective sterilization, while the dual-waste DPTE-BetaBag® system enables safe waste handling without breaking containment.

Cost-effective rigid-wall isolator for aseptic applications

Industrial sterilization processes are employed in different industries to completely eliminate all living microorganisms from the final product. For instance, in food processing, sterilization equipment is used to produce a stable product with a long shelf-life by eradicating harmful bio-contaminants. Instead, in the medical field, sterilization technologies aim to prevent the transmission of microbes to patients by sterilizing all the tools and medical devices that come in contact with the patient. Most sterilization equipment, such as autoclaves, employs high-temperature pressurized steam to destroy bacteria and disinfect surfaces from spores. Other methods include radiation sterilization or using chemicals such as hydrogen peroxide for disinfection.

Sterilization

In the pharmaceutical and biotech industries, ensuring an aseptic environment during the transfer, manipulation, and testing of materials is critical. Contamination can lead to significant product loss and safety risks, making the need for reliable containment solutions paramount.
<h2>Ensure sterile conditions with modular containment</h2>
The ISOFLEX by Getinge is a modular aseptic GMP isolator designed to maintain an enclosed and sterile environment throughout various processes, such as sterility testing and aseptic processing. A key feature is its modular design, which allows customization to meet specific process requirements. The isolator offers flexibility with its three-glove or four-glove versions, large front window for ergonomic loading, and options for bio-decontamination airlocks. The ventilation system can be configured for either Engineered Turbulent Flow (ETF) or Unidirectional Airflow (UDAF), ensuring the appropriate sterile conditions for different applications. Additionally, advanced process control is achieved via Siemens or Allen Bradley PLC systems, complemented by a 19” touch panel PC for easy operation. The system is FDA 21 CFR Part 11 compliant, ensuring it meets stringent regulatory standards.

Modular Gmp isolator for aseptic processing

In pharmaceutical production, transferring sterile or toxic materials between different containment areas poses significant challenges. Contamination risks and maintaining sterile conditions are critical concerns that need to be addressed to ensure safety for both the operator and the product.
<h2>Enable secure bi-directional material transfer</h2>
The DPTE® Beta Containers by Getinge offer a reliable solution for transferring materials in and out of barrier systems without breaking containment. These containers are available in stainless steel or polyethylene and ensure safe, contamination-free transfers in life science applications. The system uses an Alpha part interacting with a Beta part, each fitted with a door, lock, and sealing function. These containers can be sterilized using autoclave, gamma irradiation, or H2O2 bio-decontamination methods, making them suitable for a wide range of sterilization processes. Optional racks and accessories enhance the versatility and usability of the containers, enabling secure loading and unloading. The containers are compatible with the Getinge DPTE® Alpha flange, ensuring a leak-tight and reliable transfer process.

Reusable containers for sterile and toxic material transfer

A loading system feeds your continuous or batch processing machine with the specified material or item in line with the flow of production. Loaders transfer the articles from one stage of preparation to the next with uniformity and accuracy.

Loading

Unloading

Manual

In sterile or hazardous environments, maintaining containment and preventing contamination during the transfer of materials is crucial. Situations such as cleanroom operations, filling lines, or isolator applications need a reliable method to ensure safety and sterility.
<h2>Ensure contamination-free transfer</h2>
The DPTE®-XS Alpha Port by Getinge is a robust solution designed for safe and leak-tight transfer in aseptic or toxic working areas. Featuring a manual 60° rotation to connect Alpha and Beta parts, this port ensures that openings and closures do not compromise sterility or containment. Its lip seals provide a validated, air-tight connection, establishing it as the industry standard for reliable and safe transfer processes. Widely applicable in processes such as liquid and component transfer, waste disposal, and environmental monitoring, the DPTE®-XS Alpha Port is validated to meet rigorous international regulations, thereby assuring quality and safety in diverse industrial applications.

Aseptic transfer port for secure bi-directional transfer

In pharmaceutical laboratories, producing tablet batches for feasibility studies, development, and clinical trials necessitates precise coating technologies. Handling small-scale batches with intricate coating requirements can be challenging without the right tools.
<h2>Ensures consistent and precise tablet coating</h2>
The LDCS Hi-Coater® by Freund is a laboratory development coating system designed for process feasibility, development, and clinical batches. This portable, self-contained unit features six fully perforated interchangeable pans ranging from 0.5L to 8L, accommodating batch sizes from 0.04 kg to 6.4 kg. With an anti-marking coating pan, recipe-driven control system, and anti-bearding spray gun, the LDCS ensures uniform and consistent coating. The system supports film, sugar, and solvent coatings, and includes an integral drain for rapid cleaning. Optional features such as Smart-Safe™ containment, mini-tab pans, and inline PAT monitoring enhance its versatility. The user-friendly color touchscreen control system offers automatic and manual modes, maintaining precise control over inlet airflow, pan pressure, and spray rate. The system meets the 21 CFR Part 11 data handling requirements, ensuring compliance with regulatory standards.

Tablet coating system for laboratory development

Batching

To coat your consumer products with color or taste-enhancing substances, specialized technologies are available that ensure all the contents are individually and evenly covered. The process starts with loading your goods onto rotating drums, exposing the products to spray nozzles that treat them with your prescribed coating formula.

Coating

Pharmaceutical production requires efficient handling and storage solutions to maintain product integrity and streamline processes. Ensuring proper storage and transport of pharmaceutical tablets involves addressing challenges such as ease of movement, secure containment, and compatibility with existing process equipment.
<h2>Facilitates safe storage and easy transport</h2>
The IBC Tablet Bins from Freund offer practical solutions for handling and storing pharmaceutical tablets. Designed with versatility in mind, the bins come in two main types: wheeled and palletized. The wheeled bins include a removable trolley for easy transport and alignment with process equipment. Palletized bins are optimized for movement via forklifts or pallet jacks. Both types boast sloped upper heads for superior drainage, rounded edges to prevent product retention, and smooth surfaces suitable for high hygiene standards. Additionally, the 110° discharge cone and manual butterfly discharge valve make unloading straightforward. Constructed from AISI 316L stainless steel with FDA-approved silicone gaskets, the bins are robust and meet stringent pharmaceutical regulations. Available in various capacities from 150 to 350 liters, these bins offer flexible storage options.

Ibc tablet bins for pharmaceutical storage and handling

Almost all manufacturers will require industrial storage systems and solutions at some point during their production process. The raw materials that go into your products need dedicated storage solutions to protect them from spoilage and contamination before they enter the manufacturing cycle. Storage usually refers to particular storage space. For example, having enough warehouse storage. Or clearing out a production facility for more floor space.  However, in this case, we are referring to the equipment and solutions that make storage manageable and easier. Such equipment includes solutions such as storage racks, pallet racks and shelving systems. These are just some of many storage options available to manufacturers. Advanced technology facilitates the management of heavy duty and high density tank and silo systems by automating the delivery system and linking it with the rest of the production line.

Storage

transportation

In bio-pharmaceutical manufacturing, ensuring the safety and sterility of materials during transfer between areas can be challenging. Moving items from the washing area to sterilization/decontamination stations without contamination is crucial.
<h2>Ensures continuous sterility in material transfer</h2>
The FHC HEPA Cart Unit by Fedegari is designed to secure ISO 5 class (Grade A - EU cGMP) continuity during the safe storage and transport of aseptic products. It features H14 HEPA filters with 99.995% efficiency, maintaining clean transfer of materials and tools through Grade B environments. Made from stainless steel AISI 304, its doors can open to 90°, 180°, and 270°, providing ease of loading and unloading. The unit includes a control board with ON/OFF switch, fan alarm, air flow monitoring display, and HEPA filter differential pressure indicator. It can be used with trays from Fedegari autoclaves and self-adjusts airflow according to static pressure changes, making it a functional and practical tool for contamination control.

Iso 5 Hepa cart for aseptic material transfer

Industrial separation equipment encapsulates the separation process which is to separate components of a liquid mixture, for recovering dissolved solids from liquids. The choice of a suitable technology depends on the identification of the key physical or chemical property, such as size, mass, density, or boiling point, which sets the product of interest apart from the rest of the components. Separation technology is widely used in the pharmaceutical and chemical industries for the isolation of active ingredients and high-purity chemicals. As well as in waste management and recycling industries.

Separation

In the bio-pharmaceutical industry, ensuring sterility of products such as injectable liquids and sterile powders is critical. Any contamination during sterility testing can have significant consequences, necessitating highly reliable and repeatable processes.
<h2>Maintains strict sterility standards</h2>
The FCTS Sterility Test Isolator by Fedegari is designed to meet the rigorous requirements of sterility testing for pharmaceutical samples, including injectable liquids, ophthalmic ointments, sterile antibiotic powders, and freeze-dried drugs. The isolator incorporates an H2O2 vaporizer system standardized in Fedegari's bio-decontamination pass-boxes. This system ensures real-time biocide concentration control, with H2O2 sensors maintaining vapor concentration within ± 15 ppm for consistent process repeatability. The FCTS isolator features a non-directional BA surface finish in the working chamber, ultra-safe air-tight doors, and a stainless steel trolley for continuous material transfer. It is compliant with FDA, EMA, WHO guidelines, and various EN standards. The system is modular, allowing for customizable internal storage and placement of pass-boxes and working chambers to meet specific needs.

Sterility test isolator for injectables and sterile powders

Biotech equipment is used for cellular and biomolecular processing to develop products that improve our lives and the planet. With the help of specialized lab equipment, the active substance is manufactured or extracted from biological origin materials and typically produced in bioreactors by plant cells, microbial cells, yeast cultures, or mammalian cells. Cell isolation, cultivation, cell banking, and culture expansion are called upstream processes. After harvest, the production process moves into a downstream process to meet purity and quality requirements which is divided into cell disruption, purification, and polishing. Biotechnology equipment makes use of various laboratory machinery such as bioreactors, centrifuges and incubators.

Biotech

Ensuring sterile conditions during pharmaceutical manufacturing involves handling active pharmaceutical ingredients (APIs) and preventing cross-contamination. This is crucial when working with high-potent ingredients in environments demanding stringent contamination control.
<h2>Guarantee aseptic conditions during manufacturing</h2>
The FCIS pharmaceutical isolator by Fedegari is engineered to ensure clean and sterile conditions during the handling and dispensing of APIs and high-potent ingredients. It employs a barrier system that separates operators working in EU GMP C or D grade areas (ISO7, ISO8) from the operating area, which is maintained at an A grade sterility level (ISO5). The isolator is equipped with Fedegari's innovative Hydrogen Peroxide Vaporizer (FHPV), ensuring effective bio-decontamination of surfaces. This unit complies with FDA, EMA, WHO, and other international standards. Its configurable design includes features like AISI stainless steel chambers with a bright annealed surface and a double gasket door system for enhanced operator safety. The Thema4 process controller ensures precise control of H2O2 vapor concentration, maintaining it within ± 15 ppm for consistent results.

Pharmaceutical isolator for contamination control

Dispensing

Ensuring product sterility in pharmaceutical and biotech industries is crucial to maintaining product safety and quality. Traditional cleanrooms can sometimes fall short in providing the required sterility, making robust, controlled environments necessary.
<h2>Perform sterility tests in a controlled aseptic environment</h2>
The Sterility Testing Isolator by Fabtech is designed to allow operators to perform sterility tests in a controlled and aseptic environment, ensuring product and process integrity. Constructed with robust SS 316L material and classified under ISO 5 Grade A for laminar airflow, it provides a high level of decontamination compatible with VHP. The standard configuration includes one Pass Box with 2 Glove Ports, a main chamber with 4 Glove Ports, and a glove integrity tester. Customizable ergonomic options allow for user-specific configurations, while optional H2O2 decontamination offers additional safety measures. The system also supports on-demand process equipment and online particle counter integration for enhanced monitoring. Multiple chamber configurations are available, and the system includes password protection for different authorization levels, making it both secure and versatile for various applications within the pharmaceutical and biotech fields.

Sterility testing isolator for aseptic environments

Industrial dehumidification involves the process of removing moisture as well as controlling humidity. For example, warehouses that store grains need a controlled climate to avoid mildew and other moisture-related issues that can ruin or spoil the product. Refrigerant and desiccant dehumidifiers are used to reduce or maintain the level of humidity. Refrigerant dehumidifiers pass the air over a cold coil, cooling the air to the point where its water vapor begins to condense. Instead, desiccant dehumidifiers pass the air through a rotor containing a moisture-absorbing material. Commercial dehumidifiers are somewhat similar to their industrial counterpart in terms of function. The only big difference is the scale at which the equipment is being used.

Dehumidifying

Industrial disinfection equipment use antimicrobial agents to destroy microorganisms found on machines, floors, walls, and other surfaces. In industry, disinfection of machinery and the production area is important to prevent product contamination which may lead to spoilage and health hazards for workers and the consumer. The choice of industrial cleaning equipment depends on the level of disinfection needed, the sanitizing agent, the size of the area or objects to be treated, and the suitable method of treatment such as sterilization, pasteurization, exposure to ultraviolet light, or chemical fogging.

Disinfection

In various industrial and pharmaceutical settings, maintaining a controlled aseptic environment is crucial when transporting sensitive materials across different locations. This ensures that the integrity and sterility of the materials are preserved without contamination, particularly in operations requiring aseptic isolators.
<h2>Facilitates aseptic transfer with mobility</h2>
The Mobile Isolator by Fabtech is designed for scenarios where the work environment must be mobile or when materials need to be transferred between aseptic isolators. The Mobile Isolator is robustly constructed in SS 316L with laminar airflow ISO 5 Grade A classification to ensure high-level contamination control. It is equipped with wheels for easy movement and can be operated independently with optional battery packs. The isolator features customizable ergonomics to suit various operational needs. It comes in a standard configuration with one pass box (2 glove ports) and a main chamber (4 glove ports), including a glove integrity tester; multiple chamber configuration options are available. It also supports on-demand process equipment and online particle counter integration. H2O2 decontamination is optional for achieving an aseptic environment and maintaining process integrity. Room air intake and exhaust systems ensure a closed, controlled environment within the isolator. The system also features password protection for different authorization levels, supporting secure operation.

Mobile isolator for aseptic environment transfer

Industrial filtration equipment separates solid matter from liquid by using a filter medium. The filter allows only the fluid to pass through but retains the solid matter. The choice of filtration equipment depends on the particle size, the consistency of the mixture, and the nature of your product.

Filtration

Maintaining product sterility and integrity in parenteral drug production requires an environment free from bio-burden. This is essential to meet stringent regulatory standards and ensure patient safety.
<h2>Ensure sterile and safe drug filling</h2>
The Aseptic Filling Isolator by Fabtech is designed for batch production of Vials, Pre-Filled Syringes (PFS), and Cartridges. It features ISO 5 Grade A unidirectional airflow within the working chamber for maintaining a bio-burden-free environment. Constructed from robust SS 316L, the isolator includes customizable ergonomics to suit different operational needs. It integrates various components such as a Pass Box with 2 Glove Ports, a main chamber with 4 Glove Ports, and a glove integrity tester. Additional features like the Rapid Transfer Port, H2O2 decontamination unit, and optional IPC SCADA 21CFR compliance enhance the functionality and safety of the filling process. The scaled configurations can handle diverse production speeds, ensuring optimal performance.

Aseptic filling isolator for vial / Pfs / cartridge

In industries such as pharmaceuticals, biotechnology, and electronics, maintaining a contaminant-free environment is critical. Without proper control over airflow, pressure, temperature, and humidity, achieving regulatory compliance and protecting product integrity can be challenging.
<h2>Control airflow, pressure, temperature, and humidity</h2>
The cleanroom systems from Fabtech Technologies are custom-made solutions designed to provide a controlled environment for various industries. Manufactured to cGMP standards using scratch-resistant materials, these systems include wall panels, ceiling panels, risers, doors, view panels, and covings. Prefabricated and factory engineered, their thin and lightweight construction allows for quick and easy installation. These panels are green, non-CFC and available with PUF, PIR, and Rockwool insulation, making them environmentally friendly. Their panel densities range from 40 kg/m³ for PUF to up to 144 kg/m³ for Rockwool. The modular design allows for flush-fitting with factory-installed windows and utilities, including electrical outlets, lighting, air return, and mechanical components, which can be placed within the wall cavity before on-site installation. Fabtech is certified as per BS 476 part b from DAC and is the only Indian company with a 2-hour fire rating from Dubai Civil Defence.

Modular cleanroom panel systems

Industrial measurement equipment is used as a crucial step before products leave the production line. These measuring instruments check for correct dosage and standards. Equipment for measurement and control employs a wide range of technologies to detect inconsistencies in volumes, sizes, weights, and fill levels as well as to inspect goods for quality against a set of criteria. Specialized measuring tools allow you to minimize the probability for error to its lowest possible, ensuring that both products and packaging meet your benchmarks.

Measurement &amp; Control

Modern food factories need a controlled, repeatable cleaning cycle to maintain product quality and safety. Meeting these stringent hygiene standards involves optimizing cycle times, chemical concentrations, and temperatures to ensure effective cleaning.
<h2>Ensuring repeatable cleanliness and sterilization</h2>
The Cleaning and Sterilizing In Place (CIP-SIP) system by Dutch Process Technology (DPT) offers comprehensive solutions to meet the demanding hygiene requirements of food production facilities. The system is engineered to optimize cleaning cycle times as well as adjust chemical concentrations and fluid velocities, ensuring that all cleaning specifications are met accurately. The CIP systems feature an energy-saving option that customizes the active system size to match the size of the item being cleaned, enhancing sustainability by reducing energy consumption. For processes requiring sterile environments, the SIP (Sterilization in Place) capability uses food-grade steam and sterile barriers to create aseptic conditions, maintaining a regulated overpressure to ensure complete sterilization. These systems are suitable for a range of industries, including confectionery, fruit processing, sauces, dairy, convenience foods, and personal care products.

Cleaning and sterilization system for food factories

In the pharmaceutical industry, ensuring the safety of operators, products, and the environment is critical, especially from R&D to full-scale production. Challenges such as exposure to potent compounds, maintaining product integrity, and preventing contamination necessitate robust containment solutions.
<h2>Ensure safety and compliance in pharmaceutical processes</h2>
Diosna provides advanced containment solutions tailored for the pharmaceutical industry, offering comprehensive safety for operators, products, and the environment. These solutions include the installation of mixer granulators, fluid bed systems, or single-pot processors in hermetically sealed isolators, capable of operating under negative pressure. The isolators' design ensures minimal risk of leaks and contamination. Advanced transfer systems are included for safe loading and unloading of auxiliary materials and finished products. Additionally, the isolators allow for continuous operations with options for product testing and sampling without exposing the environment. Post-process, the entire interior is decontaminated, ensuring readiness for the next application. This flexibility and ease of use are crucial during product development and production, and everything can be customized in collaboration with Diosna, Incorporating scales, pumps, and mills as needed.

Containment solutions for pharmaceutical production

Blending

Granulation

Industrial mixing equipment is used to combine two or more solid, liquid or gaseous segregated ingredients into a homogenous single product. The choice of mixing technology depends largely on the physical state of the ingredients and the desired final product. But the sensitivity of the ingredients, the process temperature, and pressure requirements are also critical factors. All these parameters result in a wide range of industrial mixers.

Mixing

In industrial settings where powders must be transferred from large bags to process equipment, maintaining control and safety is crucial. Efficient emptying of bulk materials minimizes contamination, spills, and product loss.
<h2>Discharge powders safely and efficiently</h2>
The Big Bag Emptying Station from De Dietrich Process Systems offers a contained, controlled environment to empty powders from Flexible Intermediate Bulk Containers (FIBCs) into subsequent processing steps. The station can handle everything from easy-flowing to highly consolidated powders and is customizable to meet unique plant requirements, whether for new installations or retrofits. Integration with the De Dietrich Powder Pump allows for seamless material transfer, while optional components like a fluidizing hopper, automatic bag tensioning, and high-containment cabinets enhance functionality. The station is controlled via PLC and HMI, suitable for hazardous areas, and can include batch weight monitoring. It’s an adaptable system designed for diverse industrial applications involving raw or intermediate powdered products.

Big bag emptying station for powder handling

Emptying

Integration

In research and development or small-scale production within the fine chemical and pharmaceutical industries, precise and efficient liquid-solid separation is crucial. Traditional filtration systems often struggle with corrosion resistance and ease of cleaning, causing delays and product integrity issues.
<h2>Optimize filtration and collection processes</h2>
The Glass Nutsche Filter from De Dietrich is designed to meet the stringent requirements of R&D and small-scale production environments. The filter features a mobile filter plate and a height-adjustable blade for smoothing the filter cake, facilitating easy access and manipulation. With a wheel-mounted base, it can be easily moved between locations. Corrosion and solvent resistance, along with a smooth, pore-free surface, ensure minimal contamination and ease of cleaning. Additionally, the filter system utilizes vacuum during filtration to improve efficiency and includes connections for ventilation and nitrogen handling. Key industries include fine chemicals and pharmaceuticals, and capacities range from DN300 to DN600 with a maximum filling volume of up to 70 liters. The system's design allows for quick product collection and straightforward substitution of the filter cloth, making it a versatile and user-friendly option for demanding applications.

Glass nutsche filter for fine chemical and pharmaceutical filtration

In pharmaceutical environments, ensuring thorough decontamination of materials and surfaces is critical to maintaining sterile conditions. Vaporized Hydrogen Peroxide (VPHP) is a common method, but accurate testing and monitoring are essential to confirm effectiveness and safety.
<h2>Tests and monitors Vphp decontamination processes</h2>
The VPHP Testing Isolator from Comecer is designed specifically for analyzing decontamination processes using vaporized hydrogen peroxide (VPHP) in pharmaceutical fields. It enables the implementation and control of decontamination cycles, checking H2O2 residues inside the chamber and on exposed materials post-cycle. The isolator continuously monitors and records concentrations of H2O2, even detecting extremely low levels (less than 3 ppb) during final phases using a high-sensitivity sensor. The unit works in positive pressure relative to the lab to ensure sterility and includes features such as a VPHP generator for work area decontamination, an airflow velocity probe, and sensors for temperature, humidity, and H2O2 concentration. It also supports desorption tests inside the chamber, further ensuring material safety post-decontamination. This isolator is essential for pharmaceutical decontamination testing and maintains robust control over the decontamination cycle.

Isolator for Vphp decontamination testing

In pharmaceutical and radiopharmaceutical production, maintaining sterile environments within isolators is crucial. Operators face challenges with consistent and effective decontamination, which often requires time-intensive processes and leads to potential errors.
<h2>Automates and guarantees decontamination</h2>
The VPHP - Vapor Phase Hydrogen Peroxide generator from Comecer is designed to simplify and enhance the decontamination process within aseptic isolators. Utilizing VPHP, the system ensures a 6-log reduction in contaminants, making it highly effective in sterilizing isolators while minimizing operator intervention. The compact generator integrates seamlessly into existing isolators without impacting laboratory classified areas. This integration reduces the length of the distribution circuit, compresses process times, and minimizes waste. Furthermore, VPHP technology respects environmental standards and is increasingly being adopted in the industry despite initial hesitations. The system also features the Illuminate™ MI platform, providing real-time data and facilitating better factory-floor management. It is ideally suited for applications in both pharmaceutical and nuclear medicine environments.

Vapor phase hydrogen peroxide generator for isolator sterilization

In settings where handling radioactive materials is necessary, ensuring personal safety is crucial. Challenges include shielding against radiation exposure and securely transporting vials containing hazardous substances. Reliable containment with adequate shielding is needed to meet safety standards.
<h2>Ensure safety with adequate radiation shielding</h2>
The VC Series by Comecer offers stainless steel vial containers designed for personal protection from radioactive exposure. These containers feature 4 mm lead shielding, providing substantial protection against radiation. Each container is constructed of durable INOX AISI 304 Scotch-Brite™ stainless steel, ensuring longevity and corrosion resistance. The standard version includes one adapter for your vial, with options for additional lead glass windows. An optional shielded plug further enhances protection. Suitable for use in radiopharmaceutical, industrial projects, and nuclear medicine environments, these containers maintain safety without compromising ease of use.

Stainless steel vial container for personal protection

In cell and gene therapy applications, managing high throughput while maintaining strict aseptic conditions is crucial. Incubation steps often become the production bottleneck, limiting your capability to scale operations effectively.
<h2>Enhance cell culture handling with integrated flexycult incubation</h2>
The ValueCell FLEXY by Comecer is a versatile isolator designed specifically for cell and gene therapy applications. It tackles the common bottleneck associated with incubation steps by integrating with the FlexyCult system. This configuration allows for efficient, aseptic handling of cell cultures and ensures a scalable solution for high-throughput environments. The isolator features laminar airflow and a fully PLC-controlled system with GAMP 5 compliant software. It includes essential laboratory instruments such as centrifuges, refrigerators, and culture ovens. Made from high-grade stainless steel (AISI 316L internally and AISI 304 externally), the isolator also includes an integrated decontamination system using Vapor Phase Hydrogen Peroxide (VPHP). Its modular design provides the flexibility to expand and tailor the system to specific needs, making it ideal for ATMP manufacturers.

Cell & gene therapy isolator with integrated incubation

Industrial centrifuges are widely used for mechanical solid-liquid separation of components in the pharmaceutical and chemical industries. This is achieved by rapidly rotating the contents within a container to separate fluid of different densities or to remove liquids from solids.

Centrifuging

Industrial cooling equipment varies according to the consistency and temperature conversion demands the material you are handling, but the process typically involves heat exchange treatment as your products are conveyed through a cooling chamber equipped with extraction fans or circulating water. Temperature control is a crucial aspect of your commercial production and cooling systems are applied to a range of industries.

Cooling

In cell and gene therapy manufacturing, maintaining a sterile processing environment while accommodating complex workflows and various equipment is crucial. Challenges include dealing with different decontamination needs and optimizing available space for efficient processing.
<h2>Enhance cell therapy production efficiency</h2>
The ValueCell COMBI is a modular isolator designed by Comecer for cell and gene therapy manufacturing. This combinable set of modules allows for flexible and customizable setups to suit different processing needs. It includes advanced features such as a Laminar Flow Hood for manual decontamination, a mousehole door for safe material transfer, and options for integrated freezers and cooling systems. The system supports parallel processing, making it possible to handle tens of patients simultaneously. It also offers full upstream, processing, and downstream operations capabilities, including integrated filling and product packing. The Illuminate™ MI platform provides real-time data for maximizing efficiency and reducing downtime. This isolator system is suitable for small-to-medium cell and gene therapy manufacturers aiming for a versatile and comprehensive solution.

Cell and gene therapy modular isolator

<span style="font-weight: 400">At last, you reached the final stage of processing your product - welcome to the packing world! Packing preserves and protects a product from damage, spoilage, and contamination while it makes its way from the production line to the consumer or further production. Depending on which industry your products belong to, the type of primary packaging equipment can change drastically. You need to pay careful attention to products with </span><span style="font-weight: 400">chemicals or hazardous substances since they can be potentially dangerous to human health. </span>

Packing

In nuclear medicine, ensuring safe and efficient transport of radiopharmaceuticals is critical. Traditional containers may not provide adequate radiation shielding, posing safety risks during transport and handling.
<h2>Ensure safe transport of radiopharmaceutical syringes</h2>
The Syringe Shielded Container from Comecer is specifically designed to transport 5 ml and 10 ml syringes containing radiopharmaceuticals. Constructed from lead and covered in fibre-reinforced plastic composite materials, these containers provide 15 mm lead-equivalent shielding. The containers are closed by a threaded device and feature a built-in stainless steel handle for secure handling. With color-coded options—blue for 5 ml syringes, light blue for 5 ml with PST shielding, dark green for 10 ml syringes, and light green for 10 ml with PST shielding—users can easily identify the correct container for their needs.

Syringe shielded container for radiopharmaceuticals

Sealing

In the handling and disposal of contaminated needles in radiopharma facilities, ensuring safety from radiation exposure is paramount. Traditional methods often fall short, requiring specialized solutions to mitigate these risks effectively.
<h2>Storage and shielding for contaminated needles</h2>
The SNC-103 Shielded Needle Container from Comecer is designed specifically for the safe storage of contaminated needles. Its exterior is finished with an impact-proof powder coating, ensuring durability and resilience in demanding environments. The container features a stainless steel top lid, providing additional security, while the hole is covered with an aluminum lid. The shielding is made of 3 mm thick lead (Pb), offering robust radiation protection. With inner dimensions of 290 x 177 x 250 mm (w x d x h), it accommodates a variety of needle sizes. This container is essential for maintaining safety standards in radiopharma settings.

Shielded needle container for contaminated needles

In the research and development phase, especially in chemical and pharmaceutical processes, maintaining strict separation between the operator and hazardous materials is crucial. Proper containment ensures both the safety of the personnel and the integrity of the research environment.
<h2>Ensures operator safety during manipulation processes</h2>
The Six Stage Research and Development Isolator from Comecer is designed to provide maximum protection for operators during material handling. Featuring six glove box chambers, it includes designated areas for reactors, prechambers, synthesis, and drying. The isolator utilizes a turbulent flow system with nitrogen and maintains negative pressure relative to the laboratory environment, ensuring containment. Fully PLC controlled, it features an integrated vacuum dryer, oxygen monitoring, and a continuous liner system. The internal sliding door and glove ports make it user-friendly while ensuring operational safety.

Six stage r&d isolator for safe material handling

Industrial drying machines are designed to remove moisture from your product. But the drying process must cater to variations in the state of matter and molecular structure of the input material. Industrial dryer technology exploits the modes of heat transfer (convection, conduction, radiation, evaporative cooling) to control the moisture content.

Drying

When producing radiopharmaceutical generators like Rb-82, maintaining strict aseptic conditions and ensuring high productivity are crucial. Additionally, handling hazardous materials safely and efficiently poses significant challenges in the manufacturing process.
<h2>Ensure sterile, high-volume rb-82 generator production</h2>
The Rb-82 Generators Production Plant by Comecer is a sophisticated facility designed for the aseptic production of Sr-82/Rb-82 generators. Comprising eight shielded isolators interconnected for seamless operation, the plant utilizes lead shielding of varying thicknesses (125mm, 75mm, 50mm) to ensure worker safety. Integrated automation systems manage the formulation, filling, and washing of generator columns, adhering to GMP and FDA requirements. The aseptic area (Class A – ISO 5) features automatic sterilization via vaporized H2O2 generators. Conveyor systems and automatic assembly stations assist throughout the process, culminating in rigorous QC and sterility testing of the final product. The plant's design supports high productivity, enabling the production of 100 generators in an 8-hour shift, up to three times a week.

Rb-82 generators production plant

Formulation technologies are an integral process in many industries such as pharma and food. Chemical mixtures require strict handling to combine the separate ingredients into the homogenized recipe that makes your final product. Formulation technology stores, mixes and subjects the elements to a range processing parameters according to your specifications to develop the base material. The resulting formulas are then weighed, formed, packaged, or sent for further formulation.

Formulation

Industrial washing systems are used to clean and disinfect a variety of items in research and manufacturing facilities. Industrial washers use solvents and cleaning agents with mechanical action to remove deposits and residues from stainless steel machinery components, empty containers, and other soiled surfaces. The selection of an industrial or commercial washer depends on the type of items and surfaces to be cleaned, the type of deposits/residue that is typically present, whether drying is required after rinsing and the level of sterilization necessary. Manufacturers will have cleaning specifications and as a result, require washers to be engineered to meet these specs.

Washing

In radiopharmacy and nuclear medicine, managing beta radiation safely is crucial to protect personnel and ensure sample integrity. Shielding vials containing radioactive materials effectively can be challenging without appropriate shielding containers.
<h2>Provides clear view while shielding beta radiation</h2>
The PVC-0 Perspex Vial Container by Comecer is designed for the effective shielding of beta radiation. Constructed from Perspex material with a thickness of at least 10 mm, it provides robust protection while allowing a clear view of the vial contents due to its polished interior. The standard shield accommodates 5 mm vials, making it suitable for common vial sizes used in radiopharmacy. This container is essential for laboratories requiring both visibility and safety in handling radioactive samples.

Beta radiation shielding for vials

In laboratory environments where precision and safety are paramount, operators need to handle powder preparation and weighing with minimal contamination risk. Traditional setups often expose operators to hazardous materials and require extensive safety protocols.
<h2>Ensures operator safety with negative pressure</h2>
The production isolator by Comecer is specifically designed to protect operators during powder preparation and weighing activities. Operating at negative pressure compared to the laboratory, it ensures contaminants do not escape into the work environment. Equipped with a water washing system, a drainage system, and a compressed air drying system, this isolator maintains a clean and controlled workspace. The main chamber effectively confines hazardous materials while enabling precise dispensing and weighing.

Production isolator for powder preparation and weighing

In laboratory settings, especially within the pharmaceutical sector, maintaining aseptic conditions during sterility testing and manipulation of sterile products is critical. This often becomes a challenge during reactor charging operations due to potential contamination risks.
<h2>Ensure aseptic conditions for reactor charging</h2>
The Preparation Tank Isolator from Comecer is designed to provide lab professionals with a controlled environment for safe and sterile handling of pharmaceutical products. This isolator features a hinged front view panel with an inflatable seal and gas springs for easy operation. Ergonomically mounted with a 5° inclination, it incorporates oval glove ports made of polypropylene for safe materials handling. Additionally, the isolator comes with Vapour Phase Hydrogen Peroxide (VPHP) generators for effective bio-decontamination. The internal shelves are made from SS 316L, and the system includes connections for Water for Injection (WFI), compressed air, vacuum, and nitrogen, ensuring comprehensive utility. The design, which includes a main chamber and an In&Out-Chamber, fulfills the needs for sterility and ergonomic operation during reactor charging processes.

Preparation tank isolator for reactor charging

In nuclear medicine, preparing radiopharmaceuticals safely and efficiently is crucial. Traditional laminar flow hoods might require extensive cleanroom setups, demanding substantial investments and space. Ensuring sterility and operator safety during cellular labeling procedures presents a significant challenge.
<h2>Maintain sterility and protect operators</h2>
The PHL Series from Comecer is a sterile isolator designed for cellular labeling in nuclear medicine. It effectively replaces the need for a full cleanroom environment by providing a contained, sterile space for handling sensitive materials. The PHL Series features a laminar air flow working chamber and a lateral pre-chamber to facilitate material transfers without compromising sterility. The internal environment is kept under negative pressure relative to the external environment, abiding by Radiation Protection Standards. Key operational parameters can be monitored via a 7” touch-screen operator panel. Maintenance and cleaning are simplified with features like a fully openable front wall and mounted wheels. The isolator facilitates compliance with Good Radiopharmacy Practice Standards, ensuring high safety for both products and operators.

Sterile isolator for cellular labeling

Labels provide customers with important information about both your product and your brand. Different labeling technology attaches the printed film to the packaging using a range of methods such as shrink wrapping, side sealing, and adhesives. For added traceability and protection, you may also use serialization coding equipment and anti-tampering labeling systems.

Labeling

Handling radiopharmaceuticals in vials and syringes requires stringent aseptic conditions and precise dispensing techniques to ensure safety and accuracy. You may face challenges in contamination control, operator safety, and the need for flexibility when managing different container formats.
<h2>Ensures safe and accurate radiopharmaceutical dispensing</h2>
The PHAEDRA is a radiopharmaceutical dispensing isolator developed by Comecer. The unit is fitted with a Class A chamber and a universal extraction system that maintain aseptic conditions while transferring vials and syringes. The isolator includes tele-pliers with a QuickPlug system for precise handling, and a shielded front door. A user-friendly touch screen interface integrates dispenser and dose calibrator controls, enhancing operational efficiency. PHAEDRA is ideal for dispensing high-activity PET emitters due to its 75 mm lead shielding and the combination of tele-pliers and hand door manipulation ensures ergonomic use. Additionally, the isolator can manage batches of up to 20 vials (15 ml) and is compatible with hydrogen peroxide decontamination systems.

Radiopharmaceutical dispensing isolator for vials and syringes

Pharmaceutical environments that handle radiopharmaceuticals require systems that ensure both operator safety and adherence to stringent contamination standards. Maintaining sterile conditions while enabling efficient handling of radioactive substances is crucial.
<h2>Combine synthesis and dispensing in sterile conditions</h2>
The PHAEDRA COMBO Series by Comecer is a versatile shielded isolator designed for the synthesis and dispensing of radiopharmaceuticals under sterile conditions. It integrates a synthesis chamber with up to Class B air quality and a dispensing chamber with Class A air quality laminar flow. Equipped with a Class B pre-chamber, this isolator ensures contamination-free material transfer. It features a modular design with ergonomic handling using gloves and tele-pliers, ensuring safe and precise operations. A touch-screen operator panel enables easy monitoring and control. Additionally, a dose calibrator compartment, waste management systems, and integration with Comecer's Illuminate™ MI platform for real-time performance data make this system suitable for small laboratories and large production facilities alike.

Shielded isolator for radiopharmaceutical synthesis and dispensing

Synthesis

In nuclear medicine or radiopharmacy settings, handling and disposing of radioactive waste safely is critical. Common challenges include ensuring radiation shielding, facilitating secure access, and minimizing contamination risks.
<h2>Manage radioactive waste with integrated shielding</h2>
The MWC-102/202 from Comecer is a stainless steel work bench equipped with a shielded waste module for radioactive waste storage. This bench features a 3 mm lead shielding in all directions, ensuring safe containment of radioactive materials. The design includes a plastic container within the module that can be accessed through a top opening covered with a shielded lid, and through a lockable front door that opens to the right. The inclusivity of one (MWC-102) or two (MWC-202) waste passages on the worktop makes it versatile for various operational needs. Its robust INOX AISI 304 Scotch-BriteTM frame ensures longevity and ease of maintenance. Whether used in a hospital pharmacy or radiopharmacy setting, it provides a reliable solution for managing radiation safety and waste disposal.

Shielded work bench for radioactive waste management

Rinsing

In nuclear medicine, the precise and safe synthesis and dispensing of radiopharmaceuticals are crucial. Handling radioisotopes like Gallium-68 demands equipment that not only shields against radiation but also maintains a sterile environment to comply with Good Radiopharmacy Practices.
<h2>Optimize gallium-68 synthesis and dispensing</h2>
The MUSA 68Ga from Comecer is a shielded laminar flow isolator designed for the aseptic synthesis and dispensing of Gallium-68. It features a 50mm lead shielding and multiple airtight compartments maintained under negative pressure to ensure operator safety. Equipped with a dose calibrator available in 2 Ci or 20 Ci versions with a touchscreen console, the isolator is built to handle beta- and gamma-emitting radiopharmaceuticals. Its modular design supports the fractioning of PET/SPECT emitters and labeling of various radioisotopes, including 177Lu and 90Y. The isolator includes a separate compartment for Gallium-68 generators and can house compact synthesis modules and peristaltic pump dispensers for precise dosing. Additionally, the unit complies with cGMP standards and is tailored to streamline decontamination and cleaning procedures.

Shielded isolator for gallium-68 synthesis and dispensing

In pharmaceutical laboratories, maintaining aseptic conditions is crucial for accurate sterility testing of products. Traditional methods may not meet rigorous standards, resulting in compromised test results or potential contamination. Therefore, a reliable solution is required to ensure sterility throughout the process.
<h2>Ensures aseptic testing conditions</h2>
The MSTI is a Modular Sterility Testing Isolator System from Comecer designed specifically for pharmaceutical sterility testing. It features a Grade A fully closed isolator with laminar airflow, enhancing contamination control. The system includes a VPHP decontamination generator for rapid decontamination cycles and integrates with the Illuminate™ MI platform for real-time performance data. It can accommodate various pharmaceutical containers like vials, ampoules, syringes, and cartridges, thanks to its customized internal solutions. This flexibility, combined with compliance to CFR21 Part 11 and Data Integrity requirements, makes it an efficient and user-friendly option for lab professionals.

Modular sterility testing isolator for pharmaceuticals

In the fields of regenerative medicine and tissue engineering, maintaining aseptic conditions during cell culture is paramount to avoid contamination and ensure successful outcomes. The challenge lies in creating an isolated environment that meets stringent regulatory standards while minimizing human error and operational costs.
<h2>Ensure sterile conditions with automated decontamination</h2>
The Modular Cell Culture Isolator (MCCI) by Comecer is designed to provide a controlled and sterile environment for cell culture processes. With its fully welded enclosure and integrated ventilation system, the MCCI ensures a consistent Class A environment in a more compact footprint than traditional clean rooms. Featuring a top-class sterilization protocol using a VPHP cycle, it minimizes manual interventions, thus reducing the risk of human error. The isolator's ergonomic glove boxes facilitate operator comfort and efficient space utilization. It is equipped with H14 HEPA filters for both intake and exhaust, maximizing particulate control and flexibility in handling hazardous materials. The MCCI's integrated H2O2 gas decontamination system allows for effective sterilization of both the entire internal volume and specific compartments like the transfer hatch. This modular system is ideal for tissue engineering and biotech labs constrained by regulatory bodies such as FDA, EUP, and USP. Additionally, it offers viable and non-viable continuous monitoring, managed by GAMP 5 software and SCADA systems for 21 CFR Part 11 compliance.

Isolator for aseptic cell culture processing

Handling high-radioactivity isotopes like Mo-99 requires specialized environments to ensure safety and precision in dispensing and packaging. Traditional setups often struggle with safety interlocks and radiation shielding, posing operational challenges.
<h2>Safely dispense and package high-radioactivity mo-99</h2>
The Mo-99 Dispensing, Packaging, and Storage Plant by Comecer is a cGMP double hot cell designed for the non-sterile API manufacturing of Mo-99. It offers fractionation, calibration, and preparation for shipment while ensuring safe handling of up to 65 TBq of Mo-99. Each chamber is shielded with 180mm of lead to withstand high doses of ionizing radiation. The system includes SIL-3 certified safety interlocks compliant with IEC 61508 standards, providing reliable monitoring and secure access points. Furthermore, dose calibrators in the hot cell accurately measure high-radioactivity levels. The plant also provides the capability to connect 1.2 Ton transport flasks through a ceiling door, alongside waste extraction systems and compatible connections for B(U) containers in various formats.

Mo-99 dispensing and packaging hot cell

Calibration

During the synthesis of radiopharmaceuticals, ensuring operator radioprotection and maintaining sterility and cleanliness are critical challenges. Effective containment of radioactive materials and prevention of contamination are vital for safe and compliant operations.
<h2>Ensure radioprotection and sterility in synthesis processes</h2>
The MIP Series Shielded Cell by Comecer is designed to host automatic modules for the production and research of radioisotopes and radiopharmaceuticals. This solution provides comprehensive radioprotection and decontamination features. The work chamber is sealed, shielded on every side, and kept under negative pressure, ensuring safe working conditions. With options for 75 mm or 100 mm lead shielding and compliance with Class B air quality standards (at rest), the MIP Series accommodates various synthesis modules, including large, complex systems like HPLC. Additionally, the system features an advanced drawing system for vial extraction without chamber opening, further enhancing safety and operational efficiency. The MIP Series includes a touch-screen operator panel for real-time monitoring, stainless steel fluid supply lines, and an array of customizable features such as tele-manipulators and autoclaves. It meets cGMP guidelines, making it suitable for advanced research and routine production.

Shielded cell for radiopharmaceutical synthesis

In the pharmaceutical world, encapsulation refers to various techniques to enclose and protect the drug ingredients by forming the capsule shell. Encapsulation equipment changes depending on whether the manufacturer needs to produce a soft or hard gel capsule. For instance, encapsulation systems and machines for softgels control the entire process from start to finish because their shells are filled at the same time they are produced. On the other hand, the filling of hard gel capsules comes by separating the body from the cap, and after the filling operations, the two parts are sealed together again, forming the shell.

Encapsulation

In various industrial and laboratory environments, ensuring a contaminant-free and safe work area is pivotal. Handling hazardous materials and conducting sensitive chemical reactions require separation from the external environment to protect both the operator and the process integrity.
<h2>Ensures operator safety during complex operations</h2>
The Mini Plant Isolator from Comecer is an isolator designed to provide maximum protection for the operator during operations and to ensure the separation between the external environment and the interior of the isolator itself. The isolator comprises four main glovebox chambers: entrance chamber (A), chemical synthesis chamber (B), weighing chamber (C), and products discharge chamber. It operates under a turbulent flow of nitrogen atmosphere and monitors oxygen levels to maintain safety. The isolator is maintained at a negative pressure relative to the laboratory environment, which prevents contaminants from escaping. It is fully PLC controlled and easy to clean, thereby ensuring smooth operations and minimal downtime.

Mini plant isolator for laboratory protection

In the field of radiopharmaceutical research and development, precise handling and dispensing of radioactive materials are critical. Facilities often face the challenge of maintaining stringent safety protocols while achieving accurate manual or semi-automatic dispensing.
<h2>Ensure safe and precise radiopharmaceutical dispensing</h2>
The MiniMa is a manual R&D hot cell designed by Comecer, providing an airtight and shielded environment for radiopharmaceutical dispensing. This hot cell includes a large lead glass viewing window, multiple shielded compartments, and integrated gasket systems for chamber tightness. It allows for both manual syringe dispensing and integration with semi-automatic dispensing systems. Made from AISI304 stainless steel, the interior features an ionization chamber and waste compartment, both shielded with lead, ensuring operator safety. HEPA and charcoal filters on air inlets and outlets further enhance safety. This hot cell is ideal for R&D operations in nuclear medicine and radiopharmacy.

Manual hot cell for r&d in radiopharmaceuticals

Handling high active pharmaceutical ingredients (HAPIs) in manufacturing requires stringent containment to ensure safety and precision during weighing and dispensing tasks.
<h2>Ensure safe and accurate pharmaceutical dispensing</h2>
The MDWI Modular Dispensing and Weighing Isolator from Comecer is designed to provide high containment during manipulations of potentially dangerous products. The system includes a combination of one (4) gloves chamber and one (2) gloves pre-chamber, with an optional (3) gloves chamber for process customization. Internally constructed with grade 316L stainless steel and externally with 304, it features HEPA filters for maximum safety and a spray gun for internal washing. The isolator is controlled via a 5.7” Human Machine Interface (HMI) touchscreen, compliant with GAMP 5 software standards. OEB5 containment level allows for safe manual sampling, weighing, and dispensing of HAPIs. Optional upgrades enhance functionality, including rapid transfer ports, glove leak tests, and washable components. Exhaust systems can either be channeled through dedicated piping or returned to the lab. This solution is ideal for pharmaceutical companies focusing on containment and precision in HAPI handling.

Modular dispensing and weighing isolator for pharmaceuticals

In environments where contamination control is crucial, such as pharmaceutical manufacturing, isolators are essential for washing machine parts. They ensure the safety of personnel and maintain the integrity of the surrounding environment.
<h2>Ensures complete isolation during cleaning tasks</h2>
The isolator for washing procedures by Comecer is designed to guarantee total isolation of the internal environment during the manual cleaning of machine parts. It operates within a negative pressure glovebox chamber and uses turbulent air flow for effective washing procedures. The isolator includes bag-in/bag-out filters for convenient filter replacement, and an integrated clean-in-place (CIP) system. It is controlled by a fully automated PLC system with a vaporized hydrogen peroxide (VPHP) circuit, ensuring thorough decontamination. The isolator supports all washing operations in a controlled environment, featuring right and left doors for the placement and extraction of materials, and a barrier bag for safe unloading.

Isolator for washing procedures in pharma industry

Handling and transferring Highly Active Product Ingredients (HAPIs) in pharmaceutical settings involves significant risks of contamination and exposure. Ensuring proper containment and safety during these processes is critical to protect both personnel and product integrity.
<h2>Enable secure Hapi transfer and dispensing</h2>
The isolators provided by Comecer are specialized solutions designed for the containment and safe handling of Highly Active Product Ingredients (HAPIs) during transfer and dispensing operations. These isolators consist of a primary chamber and additional secondary chambers for clean transfer. Equipped with a JUMO manometer for internal pressure control, an inverter for ventilation fan speed, and automatic valves for airflow interception, they ensure a controlled environment. Features such as a sloped chamber bottom for proper drainage of wash-down fluids, polypropylene glove flanges, and nitrile gloves enhance operational safety. The Transfer Isolator comes with additional material air lock (MAL) chambers for bin discharge, while the Dispensing Isolator includes pre-chambers and sliding trays for seamless product handling. Integrated scales and IP65 illumination units further aid in accurate and reliable processing. Suitable for pharmaceutical applications requiring high containment levels, the isolators meet various regulatory requirements for occupational safety and environmental management.