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Maker - Product Challenge

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Decontamination Technologies

Industrial

In the pharmaceutical industry, ensuring the external surfaces of ampoules and small vials are contaminant-free after filling is crucial. Regulating bodies require thorough decontamination to prevent any product contamination risk.
<h2>Ensures complete decontamination of containers</h2>
The VEGA 400 by IMA is a rotary external washer designed to thoroughly decontaminate the outer surfaces of ampoules and small glass vials after they have been filled and closed. This external washer effectively removes product particles using water or a dedicated washing media for toxic products, preventing contamination. It features seven washing stations and can handle ampoules with diameters between 10-22.5 mm and heights from 35-110 mm. The VEGA 400 ensures a constant water flow, directing contaminants towards the drainage point, and it is suitable for high-speed operations, compatible with filling and closing machines. The design includes rounded corners for improved water drainage, segregated washing circuits, and easy access to all areas for maintenance. It comes with options for RABS or isolator enclosures, and is controlled by a Siemens PLC and HMI for repeatability and safety.

Ampoule external washer for decontamination

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

Decontamination

Continuous

Ensuring sterility during material transfer in isolated production lines poses a significant challenge in the pharmaceutical industry. Traditional methods may not provide the required assurance of sterility, especially when working with Ready-To-Use (RTU) materials.
<h2>Sterilises tubs and trays using Hc-vphp</h2>
The NEBULA by IMA Group is a high-speed decontamination tunnel designed to sterilise tubs and trays containing RTU material in continuous production lines. It operates using highly concentrated vapour phase hydrogen peroxide (HC-VPHP) to achieve a 6-log decontamination of the entire external packaging surface within seconds. The tunnel integrates seamlessly with IMA LIFE aseptic fill-finish lines, enabling continuous high-speed tub introduction at rates of up to six per minute. Pressure within the tunnel's chambers is carefully managed to ensure maximum safety for both operators and the cleanroom environment, preventing hydrogen peroxide circulation within the isolator. The NEBULA's design and technology offer an efficient and reliable method to ensure sterility in accordance with GMP Annex 1 guidelines.

High-speed decontamination tunnel for pharmaceutical Rtu material

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

solid

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

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

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

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

In various industrial and laboratory settings, safe decontamination procedures are essential to prevent contamination and ensure compliance with stringent hygiene standards. Traditional methods may not adequately address the removal of hazardous substances from personnel or equipment, necessitating a more effective decontamination solution.
<h2>Facilitates efficient decontamination processes</h2>
The DMI & DMI-SC by Comecer is a decontamination shower system designed to efficiently handle decontamination tasks. The system features an upper spray nozzle and a PVC tent to contain decontamination runoff, ensuring comprehensive coverage. The stainless steel shower tray has a raised edge to contain liquids, preventing spills. The DMI-SC model includes a controlled discharge mechanism that directs water into a polyethylene container for decay, and an automatic sensor to stop the water flow when the container is full. With a robust construction made from INOX AISI 304 Scotch-Brite™ stainless steel, the system ensures durability and ease of maintenance, maintaining a high level of hygiene. The shower tray has dimensions of 700 x 700 mm and an overall height of 2100 mm, accommodating various operational needs. Water connection is facilitated through a 1/2” attachment, and the system includes a tank with a 60-liter capacity for waste collection.

Decontamination shower system for industrial use

liquid

Managing large volumes of contaminated liquid waste in industrial settings often necessitates robust and scalable decontamination technologies. This is crucial for facilities dealing with high effluent outputs, ensuring compliance with strict safety and environmental regulations.
<h2>Treat and decontaminate large effluent volumes</h2>
The Ultimate Plus from Actini Group is a modular, continuous decontamination system designed to handle liquid effluents ranging from 16,000 to 192,000 liters per day. This system is scalable, starting with a base capacity of 3,000 liters per hour, extendable by adding up to three 3,000-liter/hour extensions. It operates with steam energy and includes an energy recovery section to preheat and precool effluent, saving up to 80% of the thermal energy used. Designed to ensure safe and efficient decontamination, it meets both European and American standards. Key features include fully automated operation controlled via a touch screen interface, all-welded heat exchangers to prevent leakage, and an option for redundant pumping systems. The system's design allows easy scalability without requiring additional automation studies, making it adaptable to varying production levels.

Industrial effluent decontamination solution

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

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

<span style="font-weight: 400">The heating process is a step of raising the temperature of food, pharma, cosmetics, and many other types of products. You may employ different heating solutions for this process, depending on the type of product you intend to manufacture. Selecting the appropriate heater machine for your product is quite important since various products require different ranges of temperatures and different ways of heat transfer using exchangers. Industrial heating equipment varies in two ways - the type of material it can process and the reaction you want to achieve.</span>

Heating

In laboratory and high-containment environments, managing large volumes of biological production effluent can be challenging. Ensuring safe, efficient, and chemical-free decontamination to meet regulatory standards is crucial for both safety and operational continuity.
<h2>Automatic effluent decontamination up to 3,000 liters/day</h2>
The MICRO30 by Actini is a versatile effluent decontamination system designed for high-containment facilities. Capable of handling up to 1,500 liters of effluent per day in its standard configuration, or up to 3,000 liters with a dual tank setup, this system uses patented all-electric heating technology. Its compact design allows it to fit seamlessly into laboratory or basement spaces. Operation is fully automated, with cycle management handled by an onboard PLC and controlled via a touchscreen interface. The system also features energy recovery to reduce consumption and maintenance facilitated by a rail system for easy tank removal. It meets stringent decontamination standards without the need for chemicals, ensuring safe and compliant operation.

Effluent decontamination system for biological production

Batch

Industrial facilities often need to decontaminate effluents containing particles or varying viscosity. Traditional methods might not meet the stringent biosafety and efficiency requirements, making it crucial to find advanced decontamination solutions.
<h2>Efficiently decontaminate effluents with customizable configurations</h2>
The Cyclobatch by Actini Group is a batch decontamination system designed for treating effluents ranging from 100 to 16,000 liters per day. It employs direct steam injection to ensure fast and even heating throughout the decontamination process. Featuring a patented tangential steam injection technology, the Cyclobatch creates cyclonic agitation within the process vessel for optimal thermal performance. Customizable configurations are available to match specific flow rates, effluent types, and biosafety levels. The system provides compliance with BSL 3 - BSL 4 / SIL 3 containment requirements and includes redundant decontamination tanks for enhanced safety. The energy recovery section enables preheating and pre-cooling without additional coolant, cutting thermal energy use by up to 80%. The Cyclobatch is fully automated, allowing oversight of the entire cycle via a PLC-controlled touchscreen interface. Ideal for sectors needing reliable decontamination, it supports up to 16,000 liters per day and reduces operating noise with SilentBlock technology.

Batch decontamination system for effluents with particles and variable viscosity

In pharmaceutical production, ensuring containers are sterile and free from pyrogens is crucial for maintaining the integrity of small volume injectable (SVI) solutions. Effective decontamination and compliance with cGMP standards are non-negotiable, addressing challenges such as contamination risks and regulatory adherence.
<h2>Ensuring sterile and pyrogen-free containers</h2>
The VEGA Series by IMA offers a reliable solution for washing and sterilizing ampoules, vials, and cartridges used in parenteral preparations. These rotary vial washers employ a configurable washing sequence that enhances cleaning efficiency and ensures compliance with FDA and EMA guidelines for sterility. The washers feature an integrated ultrasonic pre-wash connection and fully drainable washing circuit that facilitate thorough decontamination. With their compact design, they cater to low-speed production lines and high-volume output, supporting various container sizes and processing up to 24,000 pieces per hour. Additionally, the use of a recycled water loop reduces WFI consumption, contributing to sustainable operations.

Rotary vial washers for parenteral containers

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 the pharmaceutical industry, especially in biotech, the need for handling aseptic and toxic products demands highly reliable and efficient filling systems that minimize contamination risks and product loss.
<h2>Achieve streamlined vial filling with groninger integra</h2>
The Groninger integra is an advanced vial filling system designed for aseptic and toxic product processing, combining vial and isolator technologies. This integration simplifies operations, enhances safety, and reduces the risk of contamination. The system fills up to 400 vials per minute and handles volumes from 1 to 100 ml. Its innovative SmartFill technology minimizes product loss during infeed and idle modes. The integra's design reduces changeover times by 50% with fewer stopper-dependent parts and easy-cleaning features. The built-in SKANFOG decontamination ensures maximum sterility, making the integra ideal for CMOs and CDMOs committed to high standards in pharmaceutical manufacturing.

Integrated vial filling system for aseptic and toxic pharmaceuticals

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

Handling

Pharmaceutical production often requires processing pre-sterilized glass and polymer containers to maintain sterility and reduce contamination risks. Efficient filling processes are crucial for the production of small to large batches, while ensuring flexibility and minimal downtime.
<h2>Optimize sterile filling with flexible formats</h2>
The aseptic syringe filling systems by Groninger enable pharmaceutical manufacturers to efficiently fill ready-to-use (RTU) syringes, vials, and cartridges. The system allows for tool-less format changeovers, significantly minimizing setup work and downtime. It supports multiple decontamination methods, including E-Beam and H2O2, ensuring containers are free from contamination. Additionally, the unique pull-off roller technology employed by Groninger minimizes particle generation during lid removal, enhancing process reliability. The machines accommodate various filling systems like rotary piston pumps and peristaltic pumps, making them suitable for small startups to large-scale production environments. Groninger’s equipment can process up to 1,000 objects per minute, while maintaining high accuracy and consistent dosages.

Aseptic syringe filling solution for Rtu containers

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

In biomedical research facilities, such as vivariums and laboratories, ensuring effective sterilization, decontamination, and biocontainment is crucial. Challenges include maintaining biosafety levels and data integrity while preventing cross-contamination and ensuring operator safety.
<h2>Ensures effective sterilization and biocontainment</h2>
The GSS L & R Steam Sterilizer by Getinge is a stainless steel sterilization solution designed to meet the rigorous demands of biomedical research and laboratory environments. It secures containment, accurate process results, and operator safety through its advanced process management system. With sizes ranging from 0.4 to 9 cubic meters and customizable configurations, it offers flexibility to meet specific process requirements. Its design includes an airtight barrier to prevent cross-contamination in high-biosafety-level environments (BSL3/4). The ergonomic, user-friendly display and intuitive HMI provide easy handling and ensure repeatable and reliable results. The pressure vessel and piping are made of stainless steel, ensuring durability and ease of cleaning. The system also supports regulatory compliance and validation for hassle-free operation.

Steam sterilizer for biomedical lab research

In settings like microbiology labs, research institutes, and biotech labs, maintaining sterile conditions is crucial. Sterilizing various items such as glassware, machine parts, and culture media requires reliable and efficient equipment to ensure proper decontamination and sterilization.
<h2>Ensures reliable sterilization for laboratory needs</h2>
The FVG Vertical Lab Sterilizer, manufactured by Fedegari, offers a compact and user-friendly solution for diverse sterilization requirements. Available in three chamber volumes (50, 75, and 140 liters), the unit is constructed with 316L stainless steel, ensuring durability and resistance to corrosion. It features an exclusive horizontal swiveling lid with a pneumatic gasket for enhanced safety and ease of use. The integrated steam generator with an automatic water feed pump supports the sterilization of a wide range of laboratory goods, including glassware, plastic articles, unwrapped instruments, and culture media. The TSC 09 microprocessor control system with a graphic color LCD display allows precise control of the sterilization process through a dual sensor system for pressure and temperature. Additionally, the FVG series includes a heat recovery system to preheat water, thereby saving on utility costs.

Vertical lab sterilizer for laboratory sterilization

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

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

Powder

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

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

Pilot

When dispensing pre-sterile liquids, it is crucial to maintain a sterile environment to prevent contamination by airborne bio-burden. Ensuring that the liquid remains uncontaminated during the transfer and measurement process is a key challenge.
<h2>Maintains sterility during liquid dispensing</h2>
The Liquid Dispensing Isolator by Fabtech is designed to safely measure and dispense pre-sterile liquids into smaller containers. This system ensures sterility through the use of inline sterile filters and VHP (Vaporized Hydrogen Peroxide) decontamination. Built with SS 316L stainless steel, the isolator features ISO 5 Grade A laminar airflow for an aseptic environment. The standard configuration includes a pass box with two glove ports and a main chamber with four glove ports, along with a glove integrity tester. The system offers customizable ergonomics, multiple chamber configurations, integration options for on-demand process equipment, and online particle counters. It also supports password protection for different authorization levels.

Liquid dispensing isolator for sterile environments

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

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

Maintaining reliable and compliant purified water for large or multiple automated endoscope reprocessors is critical in medical and laboratory environments. Ensuring high water quality while managing bacterial contamination and endotoxins can be challenging, requiring robust solutions for effective decontamination processes.
<h2>Deliver purified water at high flow rates</h2>
The BIOPURE 300/600 by Elga LabWater is a water purification system designed for large-scale or multiple endoscope reprocessors and washer disinfector installations. It delivers purified water at the rate of 300 to 600 liters per hour, ensuring compliance with stringent bacterial and endotoxin specifications. This system includes a 350-liter storage reservoir and features onboard technology that guarantees reliable water quality and easy system disinfection. An automated alarm system and restricted access via the 'E key' ensure secure and efficient operation. The BIOPURE 300/600 utilizes a unique sanitization design that purifies reverse osmosis (RO) membranes and the local distribution loop, making it suitable for environments requiring rigorous decontamination standards. The supplier is ELGA LabWater, recognizable for their dedication to providing high-quality water purification solutions.

Water purification system for endoscope reprocessors

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

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 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, 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

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

Synthesis

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 pharmaceutical manufacturing, stringent standards for asepsis and containment are essential when processing intravenous (IV) bags. Traditional methods can involve significant human intervention, increasing the risk of contamination and errors.
<h2>Provides high-speed aseptic filling for Iv bags.</h2>
The automatic aseptic filling line for IV bags from Comecer is a high-speed, turnkey solution capable of processing various IV bag formats in both small and large batches. Using isolation technology from start to finish, it guarantees asepsis and containment, minimizing human intervention. The system includes in-line integrity testing and can handle bags ranging from 50 ml to 1 liter without requiring format part changes. It manages up to 2300 pieces per hour with either peristaltic or volumetric integration and incorporates LAF isolation technology along with a built-in VPHP decontamination system. Primarily used in the pharmaceutical industry, this filling line ensures complete separation between the process and the operator.

Automatic aseptic filling line for Iv bags

In pharmaceutical manufacturing, ensuring the integrity and sterility of vials and cartridges is crucial, particularly when dealing with delicate medications. Consistently high-quality sealing is necessary to prevent contamination and preserve product efficacy.
<h2>Efficiently close vials and cartridges</h2>
The HVM 4610 by Bausch+Ströbel is designed for semi-automatic closing of vials and cartridges with crimp caps or flip-off caps. This compact unit maintains the same high-quality standards as fully automatic systems to meet pharmaceutical industry requirements. It supports H2O2 decontamination, making it suitable for isolator use. With a servomotor drive, the system ensures precise and consistent closures, accommodating container diameters from 8.55 to 68 mm and heights from 32 to 136 mm. Optional features include a spacing roller at the crimping disc and complete qualification packages (IQ/OQ). The centralized operation simplifies use, making it a practical choice for maintaining consistent production quality.

Vial and cartridge crimping solution

In clinical and commercial pharmaceutical manufacturing, maintaining stringent cGMP requirements for cleanliness and sterility is crucial, particularly when processing medium-sized batches of injectable drug products. This necessitates a highly adaptable and reliable fill-finish system that ensures product integrity.
<h2>Automate aseptic filling and closing processes</h2>
The ASEPTiCell® by AST is an advanced aseptic fill-finish system designed to handle small and medium-sized batches. Featuring reliable robotics, the system facilitates a full changeover in as little as 30 minutes, boosting production efficiency. It can process ready-to-use vials, syringes, and cartridges with various filling accuracies up to ±0.5% using peristaltic and rotary piston dispensing options. The ASEPTiCell® integrates key features such as environmental monitoring, in-process fill weight control, and electronic batch record reporting. Additionally, it supports multiple aseptic barrier options, such as Restricted Access Barrier System (RABS) or isolators with in-situ bio-decontamination using hydrogen peroxide, to ensure maximum sterility. This system is compact yet versatile, fitting various modular configurations to meet specific application requirements without the cost of extensive customization.

Aseptic small / medium batch filling and closing system

Closing

In environments where small cGMP batch production is essential, maintaining sterility and speed during the fill and finish process poses significant challenges. Ensuring that components remain free from contamination while achieving rapid cycle times is critical for success.
<h2>Optimize your aseptic filling process</h2>
The spectra M1, offered by Aseptic Technologies in collaboration with SKAN, is an advanced isolated fill & finish unit specifically designed for small cGMP batch production. This system features the highly regarded SKAN nanox® catalyst and skanfog® technology, which work together to ensure fast and safe decontamination cycles. Utilizing the AT-Closed Vial® technology and the M1 Filling Station, the spectra M1 significantly boosts production efficiency by maintaining a closed filling process, which avoids contamination. The filling process accommodates volumes ranging from 0.1 ml to 50 ml and employs a peristaltic pump with an integrated weighing cell for high accuracy. The user can monitor batch status in real-time via the built-in screen, and the overall operation is compliant with CFR21 part 11 standards. Ideal for applications in cell and gene therapy, next-generation biologics, and compounding.

Aseptic filling solution for small cgmp batches

Scaling up manufacturing for cell and gene therapies often requires precise aseptic filling solutions. Common challenges include maintaining sterility, ensuring accurate fill volumes, and minimizing contamination risks, which are critical to adhering to GMP compliance.
<h2>Ensure high sterility and precise filling</h2>
The Cellana XL1 by Aseptic Technologies is a specialized aseptic filling system designed to handle the precise and sterile filling of gene therapy products, including viral vectors and plasmid DNA. This system utilizes isolator technology to provide high sterility assurance and GMP compliance. Single-use materials minimize the need for batch-to-batch changeover, ensuring efficient and flexible operations. Capable of filling volumes from 0.1 ml to 50 ml at rates up to 700 vials per hour, the Cellana XL1 offers high filling accuracy with 100% in-process weight control (IPC). Additionally, it features a rapid decontamination airlock that completes in under 20 minutes, and it is designed for grade C installation environments. Full compatibility with other isolated modules of the Cellana series further enhances its utility in comprehensive manufacturing workflows.

Aseptic vial filling system for gene therapy products

Control

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