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Dispensing Technologies

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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

Decontamination

Dispensing

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

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

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

liquid

When handling and dispensing radiopharmaceuticals, maintaining a sterile environment and ensuring radiation safety is critical. Challenges include minimizing contamination risks and precise dosage control while adhering to stringent CGMP guidelines.
<h2>Ensures sterile and shielded dispensing of syringes</h2>
The THECLA by Comecer is a class A shielded isolator featuring an integrated dispensing system specifically designed for handling radiopharmaceuticals such as 68Ga. It offers a laminar flow over the entire main chamber to maintain sterile conditions. The isolator includes a semi-automatic syringe dispensing system and a class B pre-chamber for material introduction. Key features include a dose calibrator with a measurement range up to 2 Ci and compartments for 68Ge/68Ga generator housing and dose calibration. The compact and essential design allows it to fit in confined spaces with maintenance access from the front wall. Compliance with CGMP guidelines ensures a high standard of safety and efficacy in radiopharmaceutical preparation and dispensing.

Shielded isolator for radiopharmaceutical syringe dispensing

In radiopharmaceutical production, handling materials like Radium-223 dichloride requires precise and safe processing environments to prevent contamination and ensure product integrity. Key processes such as generator loading, product dispensing, and final sterilization demand specialized solutions.
<h2>Handles the full ra-223 production and dispensing process</h2>
The Ra-223 Dichloride Production and Dispensing Suite by Comecer is designed for the comprehensive handling of Radium-223 dichloride. This hot cell suite integrates semi-automatic modules for 227Ac/223Ra chemistry processing, purification, and separation. Equipped with a high precision filling machine, it supports Class A – ISO5 environments, making it suitable for the high standards of pharmaceutical production. The filling machine uses a Flexicon® peristaltic pump for volumetric dispensing and incorporates a WIPOTEC high precision scale for 100% weight control. Operations within the hot cell are managed using a single tele-tong and shielded hand port, ensuring safety and convenience. This system is capable of filling open vials in 10ml and 20ml formats and features advanced waste management solutions, including a floor port for 227Ac generator and centralized connections for solid and liquid waste to the basement. It also includes Class-2 containment boxes made of stainless steel, AISI 316L, in line with ISO 10648 standards.

Ra-223 dichloride production and dispensing suite

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

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

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

Batch

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

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

Handling

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

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

Synthesis

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

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

Packaging

solid

Manual

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

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

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

Weighing

Powder

In nuclear medicine and radiopharmacy, precise and contaminant-free dispensing of radiopharmaceuticals like Lutetium-177 (Lu-177) is crucial. This ensures accurate dosing and patient safety while maintaining compliance with stringent regulatory standards.
<h2>Automate radiopharmaceutical dispensing processes</h2>
The Lu-177 dispensing line by Comecer is designed for the dissolution, formulation, and dispensing of Lu-177 radiopharmaceuticals. This line includes four main components: a target dissolution and formulation unit, a dispensing unit, a transfer air-lock, and a laminar airflow (LAF) hood. These units are operated by two 6-axis robots that are suitable for cleanroom environments, ensuring a high level of precision and cleanliness. The automation minimizes human error and exposure to radiation, making it an ideal choice for GMP radiopharmacies and nuclear medicine labs. The integrated systems streamline operations and enhance the overall safety and efficacy of the radiopharmaceutical preparation process.

Lu-177 radiopharmaceutical dispensing solution

Dissolution

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

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.

Isolators for safe Hapi transfer and dispensing

In research and development settings, ensuring the safety and precision of handling sensitive materials is crucial. Challenges include maintaining a contaminant-free environment and protecting operators from exposure to hazardous substances.
<h2>Ensures safe and accurate dispensing</h2>
The Dispensing Custom R&D Isolator by Comecer operates at negative pressure relative to the laboratory, offering a controlled environment for the safe handling and dispensing of materials. This isolator features hinged front view panels with inflatable seals for easy access and secure isolation. It includes circular and oval glove flanges made of polypropylene, which facilitate material handling without compromising safety. A communication door allows seamless material transfer between chambers, while the integrated drainage sanitary tank and sloped working plane ensure efficient waste management. The isolator’s connectivity options include predispositions for WFI, PW, compressed air, vacuum, nitrogen, and various other utilities. It is also equipped with an internal filter and drying system, making it ideal for pharmaceutical and radiopharmaceutical applications.

Custom r&d isolator for precise dispensing operations

Handling highly potent micronized substances, such as progesterone, in pharmaceutical processes requires a controlled environment to ensure operator safety and process accuracy.
<h2>Control micronized substance weighing and dispensing</h2>
The isolator by Comecer is designed for precise weighing and dispensing of highly potent micronized substances, with an OEL of 0.01 mg/m³. It features fully PLC-controlled operations and GAMP 5 compliant software, ensuring accurate and safe procedures. The isolator includes a pre-chamber for material inlet and a main chamber for dispensing activities, both equipped with single and dual-stage filtration. It also has a continuous liner port for easy exit of large drums, along with an integrated Hycoflex® system in the main chamber for product removal. Internal conditions are monitored using a combination of Magnahelic manometers for pressure control, an rH+T sensor for humidity and temperature, and Jumo manometers for filter obstruction monitoring. The system also includes CIP components like spray balls and guns, along with a Drying In Place feature enhancing the overall cleaning process. A Eurotherm paperless recorder captures critical process data for compliance and record-keeping.

Isolator for weighing and dispensing of micronized substances

In radiopharmacy operations, accurately dispensing radiopharmaceuticals into vials and syringes is critical. Incorrect dosages or contamination can lead to serious quality control and regulatory issues, necessitating a reliable system for precise and sterile dispensing.
<h2>Dispense radiopharmaceuticals accurately and efficiently</h2>
The CLIO Volumetric Dispensing System by Comecer is a standalone automatic system designed for radiopharmaceuticals dispensing, compliant with cGMP guidelines. The system can dispense FDG radiotracer and other tracer isotopes or molecules, subject to technical evaluation. It is capable of dispensing into open vials, closed vials via transseptal dispensing, and syringes. The compact design includes a pre-assembled consumables kit that is sterile and easy to handle. Multiple sensors and diagnostic tools ensure secure operation, monitoring consumable kit installation, vial cap presence, and vial crimping. Designed for easy integration into laminar flow hot cells equipped with a dose calibrator, CLIO's compact dimensions and low weight facilitate hassle-free movement.

Volumetric dispensing system for radiopharmaceuticals

In radiopharmaceutical dispensing, handling radioactive materials requires maintaining stringent safety standards to protect operators from ionising radiation. Shielding, precise handling tools, and sterile conditions are essential to ensure safe and compliant operations during filling, calibrating, and fractioning processes.
<h2>Facilitates safe and sterile radiopharmaceutical dispensing</h2>
The Comecer BBST Series is a family of shielded isolators specifically dedicated to radiopharmaceutical dispensing. Designed to comply with cGMP regulations, these Class A isolators feature laminar airflow across the main chamber, ensuring sterile conditions. The modular design allows integration of various automatic modules or fractioning systems. The isolators provide maximum protection through comprehensive shielding, air seals between chambers, and high-sensitivity tele-pliers for remote handling. Internal pressure is automatically adjusted by modulating valves, and fluid supply lines are made of AISI316L stainless steel for reliability. Additional features include a semi-automatic bubble point test, VPHP connections, and a dose calibrator available in two versions: 2 Ci and 20 Ci. Ideal for small to medium batch production (10-15 vials or 3-5 syringes per batch), the BBST Series is equipped with integrated measuring tools and a drawing system for product extraction.

Shielded isolators for radiopharmaceutical dispensing

In radiopharmaceutical production, ensuring sterile conditions and precise dosage is paramount. Inefficient handling of radioactive substances poses significant safety and compliance challenges within GMP standards.
<h2>Combine synthesis and dispensing in sterile conditions</h2>
The BBST COMBO Hot Cell from Comecer is a specialized synthesis and dispensing hot cell designed for radiopharmaceutical production. This system integrates a shielded housing for synthesis modules with a fractionation system, all maintained under cGMP-compliant sterile conditions. Featuring a main shielded chamber (dispensing area) with Class “A LAF” by a combined system “air tight - laminar flow,” the unit includes a pre-chamber (Class B), a shielded synthesis area (Class B), and a solid and liquid waste collection system. Advanced functionalities such as airtight connections for radioactive fluids, high sensitivity tele-pliers, and an automatic pressure adjustment system enhance operational safety and efficiency. The touch screen controls for both the hot cell and dispensing system simplify operation, while the dose calibrator (available in 2 Ci or 20 Ci versions) ensures accurate dosage. VPHP connections and a semi-automatic bubble point test (touch screen controlled) add further convenience and compliance with sterilization standards. Equipped with the Illuminate™ MI platform, this hot cell offers real-time performance data to optimize production processes.

Synthesis and dispensing hot cell for radiopharmaceuticals

In pharmaceutical manufacturing, accurate weighing and safe transfer of active pharmaceutical ingredients (APIs) are crucial. Handling these substances often involves risks of exposure to highly explosive dust, demanding stringent safety measures and specialized equipment.
<h2>Ensures precise and safe Api handling</h2>
The ATEX isolator by Comecer is designed to perform weighing and powder transfer procedures in a safe environment. The isolator features an ATEX compliant chamber, fully PLC controlled operation, and a user-friendly HMI for seamless interactions. It includes a glass front wall that fully opens, facilitating easy access, and a sliding tray along with internal storage systems made from stainless steel AISI 316L. The filtration system includes a single inlet stage within the enclosure and a double output stage, optimizing airflow and ensuring clean operations. Integrated sensors monitor the oxygen levels and Magnehelic manometers control the internal pressure. For maintaining hygiene, the chamber is equipped with two spray balls and spray guns. The isolator also has automatic valves for air flow interception and a remote panel scale for accurate weighing. A specific feature is the RTP system and a barrier sack with an interlocking door on the operating surface for secure transfer and discharge of materials, supported by an automatic lift trolley for easy transport of rejects. This isolator ensures safety in the handling of highly explosive substances, ideal for pharmaceutical applications.

Atex compliant isolator for dispensing powder procedures

In nuclear medicine, precise and safe dispensing of radiotracers is crucial for both diagnostic and therapeutic applications. Handling radiopharmaceuticals manually can lead to inaccuracies and safety risks, necessitating advanced dispensing technology.
<h2>Ensure accurate radiopharmaceutical dispensing</h2>
The Argo Vial Dispensing System by Comecer is designed to automate the dispensing of radiotracers used in PET and SPECT diagnostics as well as therapeutic radiopharmaceuticals. The system operates under cGMP guidelines, ensuring compliance with stringent regulatory standards. The integrated scale verifies the filling process with high accuracy, monitoring the weight of the vial during dispensing. Argo's compact design facilitates easy positioning in shielded isolators, providing ergonomic and convenient operation. The system can dispense volumes with an accuracy within ± 5% for >1ml and ± 0.08 ml for 0.5–1 ml volumes. Additionally, it includes features such as a label printer for vials, a sterilizing filter, and a barcode reader for tracking. Functional for FDG and adaptable for various isotopes, Argo ensures a reliable and efficient workflow in nuclear medicine departments.

Automatic vial dispensing system for nuclear medicine

In radiopharmaceutical production, precise and contamination-free dispensing of radiotracers is crucial for PET and SPECT diagnostics and metabolic radiotherapy. Ensuring accuracy and sterility in this process helps to maintain consistent patient outcomes and complies with strict regulatory standards.
<h2>Ensure accurate, sterile, and compliant vial filling</h2>
The ARGO-T (Transseptal) Closed Vial Dispensing System by Comecer is specifically designed for the precise dispensing of radiotracers into closed vials through rubber stoppers, adhering to cGMP guidelines. The system's key feature is its ability to pierce the vial stopper automatically with a specifically designed needle, which works in conjunction with an integrated vent needle and a 0.22 μm sterile filter. This ensures sterility and accuracy in the dispensed volume, maintaining a variance of only ±5% for volumes between 1 and 10 ml. Integrated into Class A shielded isolators, the ARGO-T system ensures operator safety and minimal contamination risk. Compact and lightweight, the system can be easily positioned within the working area. Additional features include a label printer, a barcode reader, and a formulation unit that calculates the concentration and volume of radiopharmaceuticals.

Closed vial dispensing system for radiopharmaceutical production

During powder transfer operations in pharmaceutical or chemical processing, maintaining clean and efficient containment is crucial. Minimizing product loss and avoiding exposure to dust are common challenges that need to be addressed.
<h2>Ensures clean and accurate powder dispensing</h2>
The Dispensing Funnel from Chargepoint Technology is a specialized funnel designed for precise and clean powder dispensing through ChargePoint® valves. This funnel enhances containment performance and ensures accurate filling of transfer bags or containers. It directs powder cleanly through the valve, minimizing product loss and reducing dust exposure. Constructed from 316L Stainless Steel, the funnel is compatible with valve sizes ranging from DN50mm (2”) to DN150mm (6”). Typically used within a dispensing isolator, the funnel legs sit to the side of the open valve disc, ensuring that powder does not come into direct contact with the valve during the transfer. This results in a clean transfer process, providing an additional safety factor. By enabling the use of more basic valve designs, the Dispensing Funnel can eliminate the need for more advanced systems.

Powder dispensing funnel

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

Bio-decontamination

In food production, it's necessary to melt and maintain specific ingredients at constant, controlled temperatures. Whether working with chocolate, syrups, or various fats, precise temperature management ensures consistent quality and processing efficiency.
<h2>Melt and maintain temperature up to 90°c</h2>
The De Daniela Tank is an electromechanical appliance manufactured by De Danieli, specifically designed for melting chocolate, syrups, and fats such as butter, palm oil, and margarine. It ensures that these ingredients are held at a constant temperature, not exceeding a maximum operating temperature of 90°C. The tank features a front drain tap for easy dispensing, making it practical and efficient for various food processing applications where precise melting and temperature control are critical.

Chocolate, syrup, and fat melting tank

<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

Melting

In radiopharmacy, ensuring precise and safe dispensing of radiopharmaceuticals is crucial to limit radiation exposure to operators and avoid contamination. Traditional manual methods often increase the risk of human error and radiation dose to the personnel.
<h2>Automate radiopharmaceutical dispensing with robotic precision</h2>
The THEODORICO 2 by Comecer is a robotic dispenser designed for the automatic dispensing of radiopharmaceuticals in either open or closed vials. Featuring a flexible and modular design, it is fully cGMP compliant and available with Pb shielding of 75 or 100 mm. The main dispensing chamber includes a robotic arm to handle all stages of vial dispensing, significantly reducing operator exposure to radiation. The system incorporates advanced features like RAC calculation, built-in Bubble Point Test (BPT), and options for dynamic air sampling and particle counting. An optional ethanol line flushes residual kit activity, ensuring thorough decontamination. This dispenser supports both aseptic operations and final sterilization, making it versatile for various radiopharmacy applications.

Robotic dispenser for radiopharmaceuticals

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

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 conducting radiopharmaceutical research, maintaining a sterile environment is essential. The need arises to prevent contamination while handling radioactive materials, ensuring both the safety of the operator and the integrity of the product.
<h2>Ensures aseptic conditions and operator safety</h2>
The MIP-LAF, offered by Comecer, is a laminar flow shielded cell specifically designed for radiopharmaceutical research activities. Equipped with complete laminar airflow across the entire work area, it ensures aseptic operation compliant with cGMP standards. The cell features modular design and flexible configurations, including an integrated touch screen for hot cell and dispensing system operation. The fluid supply lines are made out of AISI 316L stainless steel with ball shut-off valves, ensuring airtight connections for radioactive fluids. Moreover, the system includes a dose calibrator available in 2 Ci or 20 Ci versions, a drawing system for secure vial extraction, and a shielded waste compartment. The internal pressure is automatically adjusted via modulating valves, and door closure is secured using inflatable gaskets. This equipment is complemented by a high sensitivity tele-pliers and an integrated factory-floor management platform.

Laminar flow shielded cell for radiopharmaceutical research

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

In radiopharmaceutical production, precise micro-dispensing of isotopes like Lu-177 and Ac-225 is essential to ensure accurate dosages and patient safety. Achieving high accuracy in dispensing these isotopes can mitigate risks and support reliable treatment outcomes.
<h2>Ensures high accuracy in isotope dispensing</h2>
The MIKROS is a specialized micro-dispenser designed for radioactive isotopes such as 225Ac and 177Lu. It can dispense very small volumes, ranging from 10 μl to 5000 μl, with high accuracy, making it ideal for pharmaceutical environments. The system uses pipette tips for Tecan and has a barcode reader to identify vials before they move to the vial transfer system. The dispensing unit operates with two TECAN modules that move via a motorized sledge, filling conical 2 ml and flat bottom 10 ml DIN ISO 20 vials with the radio fluid or diluent as needed. Additional features include a crimping unit for stopper handling and a vial transfer system equipped with a mechanical arm and drip tray. Provided by Comecer, the MIKROS also includes a load cell for weighing vials, ensuring precise dosage control. It is suitable for use within cleanroom environments given its design for easy management of cleaning activities.

Micro-dispenser for lu-177 and ac-225

Handling and dispensing beta/gamma-emitting radiopharmaceuticals in a safe and sterile environment is crucial in nuclear medicine. Common challenges include maintaining sterility of the product and protecting the operator from radiation exposure during preparation and calibration processes.
<h2>Ensures sterility and radiation protection</h2>
The ELIZA Series Shielded Laminar Flow Isolator from Comecer is designed for handling, dispensing, and calibrating radiopharmaceuticals while adhering to Current Good Radiopharmacy Practice guidelines. The isolator features a Class A laminar flow work chamber that ensures sterility and airtight pre-chambers that conform to Class B standards. Radiation protection is ensured by designed shields, and operator ergonomics are improved by the placement of dose preparation components within easy reach. The unit includes advanced features such as a touch screen for hot cell and dispensing system management, internal pressure automatic adjustment with modulating valves, and an option for integrating automatic modules or fractionation systems. It also supports technical gases supply and solid waste collection, adhering to cGMP compliance.

Shielded laminar flow isolator for radiopharmaceuticals

In large-scale bakeries, automating cake production is essential to keep up with high demand and maintain uniform product quality. Consistent paper cup placement and synchronized batter depositing are critical to achieve the desired results without manual intervention.
<h2>Automates paper cup dispensing and batter depositing</h2>
The Depositing Line with Denester from Bakon is designed to streamline cake production in mid-sized and industrial bakeries. The Denester dispenses various shapes of paper cups onto the conveyor at an adjustable pitch, aligning perfectly with the Piston Depositor. Integrated Industrial Transfer Pumps channel different types of cake batters into the Piston Depositor’s hopper, enabling simultaneous deposition of chocolate and natural batters to create a marble effect. This robust system is capable of handling semi-liquid products like cake batter, muffin batter, and fillings with ease.

Depositing line for cake production with paper cup denester

Conveyor systems are used for moving materials from one location to another. Considerations for choosing a suitable industrial conveying system include the nature of the product, its physical state, the desired conveying rate, and sensitivity of the product to heat and mechanical shock. Conveying equipment is used in the food, pharmaceutical, chemical, biomass, and mineral industries to move materials around a warehouse as well as to transport bulk powders, granules, and grains for processing and filling. These types of systems are usually automated and there is a wide variety of solutions to choose when it comes to the type of conveyor. Types include screw, gravity, chain, roller and belt conveyors.

Conveying

Depositing equipment is a very common production line process in the food industry. Whether you want to make muffins or jellies or garnish and decorate cakes, all of this is impossible without the depositing step. Depositing is a form of extrusion used primarily to produce pieces of dough that will be further processed to create several food products. The dough is passed through a depositing machine and poured in equal parts from holes in a die plate with nozzles or a conveyor belt. But that’s not all. Depositors are also used to fill, layer, or cover your food items with other ingredients before proceeding to the next step of the production process which is usually packaging.

Depositing

When working in environments that require strict containment, such as pharmaceutical manufacturing or laboratories, traditional open handling systems can expose workers and materials to contamination risks. These challenges necessitate the use of a reliable containment solution for critical processes.
<h2>Ensure containment flexibility and safety</h2>
The Flexible Isolator from Austar is designed for effective containment in controlled environments. It offers a cost-effective solution compared to rigid isolators, featuring flexible materials that can accommodate varying operational spaces. The Flexible Isolator provides high transparency for better visual monitoring and thorough cleaning. It is compatible with a range of equipment, making it ideal for diverse applications, including dispensing, filtration, sampling, and powder conveying. With its higher economic efficiency and ability to dock with other devices, it is particularly suitable for operations that need both containment and flexibility.

Flexible isolator for aseptic containment

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