The growing complexities of modern pharmaceuticals have resulted in a rise in the production of aseptic products. This has further led to an increased demand for specialized equipment and infrastructure to maintain a microbiologically controlled environment. Since human presence poses a great risk to sterility, aseptic isolators are closed decontamination systems that enhance sterile fill-finish capacity and production capabilities.
FabL’s aseptic isolators provide continuous and complete isolation from the external environment, ensuring aseptic processes remain uncompromised. Unlike containment isolators, which use negative air pressure, aseptic isolators maintain positive pressure to preserve sterility.
Applications of Aseptic Isolators
1. Sterility Testing
Sterility testing is crucial in pharmaceutical manufacturing facilities and ensures that products remain free from viable microorganisms. Aseptic isolators create a controlled environment for methods like membrane filtration and direct inoculation, where the products and processes are protected from contamination. They are equipped with rapid transfer ports (RTPs) for the safe and secure introduction of test materials. The air within the isolator is continuously filtered and monitored to maintain sterility. These isolators maintain sterility while helping pharmaceutical companies meet regulatory standards.
2. Sterile Drug Compounding
Aseptic isolators provide a safe and clean environment for compounding hazardous sterile drug preparations by physically separating critical compounding areas from the potential sources of contamination, especially the compounding personnel. Equipped with high-efficiency particulate air (HEPA) filters, these isolators provide ISO Class 5 cleanroom conditions.
Positive pressure within the isolator ensures that any breach in the system results in air being pushed out, thus preventing contaminants from entering. The glove ports of the isolators allow operators to manipulate materials without compromising the sterile barrier. This setup is vital for preparing intravenous (IV) admixtures, chemotherapy drugs, and other parenteral solutions.
3. Sterile Injectables
The production of sterile injectables requires a uniform and effective unidirectional airflow workstation that promises a homogeneous air speed of 0.36–0.54 m/s (guidance value) at a defined test position 15–30 cm below the terminal filter or air distributor system. The velocity at the working level must consistently be lower than 0.36 m/s.
These systems often incorporate particle monitoring and microbial detection systems to ensure ongoing environmental control during production. With aseptic isolators, the filling and packaging of vaccines, biologics, and injectable drugs are carried out under these strict conditions.
4. Pharmacy Dispensing
Pharmacy dispensing is carried out meticulously. The Rapid Transfer Ports (RTPs) are equipped with double-door systems where both the isolator and the transfer container have their doors. These doors only open when they are securely docked together, ensuring a continuous sterile pathway.
These systems can be used in both directions, allowing materials to be transferred in and out of an isolator. Airlocks with integrated decontamination systems ensure that products are transferred aseptically into and out of containment areas. Additionally, isolators use decontamination techniques such as vaporized hydrogen peroxide (VHP) or ultraviolet (UV) light to sterilize items before transfer, further reducing the risk of contamination.
5. Medical Device Manufacture and Assembly
Glove ports and integrated manipulation tools within the aseptic isolators allow operators to assemble and continuously inspect devices without breaching the sterile barrier. Particulate monitoring systems and a HEPA filter for laminar air flow maintain ISO Class 5 cleanroom conditions, thus maintaining the required sterile conditions throughout the manufacturing process. The ability to control environmental parameters such as temperature, humidity, and airflow within the isolator ensures consistent product quality and compliance with stringent regulatory standards for medical device manufacturing.
6. Packaging
Aseptic isolators used in packaging are equipped with automated filling and sealing systems that operate within a sterile environment. Pre-sterilized components and continuous air filtration through gamma irradiation, autoclaving, or other sterilization methods, ensure that the packaging process remains contamination-free. After the packaging process is complete, the isolator and its contents may undergo decontamination to eliminate any potential contaminants before the next production cycle.
7. Integration of Key Monitoring, Processing, and Decontamination Systems
Key monitoring systems, such as particle counters and microbial detection systems, continuously track the cleanliness of the isolator environment, ensuring that any deviations from acceptable conditions are immediately detected and corrected. Processing systems, such as automated filling lines and material handling robots, are also integrated into the isolator to perform sterile operations with minimal human intervention.
Decontamination systems like VHP generators, ultraviolet (UV) light, and airlocks with integrated decontamination systems are incorporated to sterilize the isolator and its contents before and after each use. This comprehensive integration ensures that the isolator operates as a fully contained, self-sufficient unit, capable of maintaining the highest standards of sterility and efficiency in pharmaceutical and biotechnology applications.
Aseptic Cleanroom Containment Solutions by FabL
1. Liquid Dispensing Isolators
This is FaBL's safe transfer mechanism to safely transfer products into the Liquid Dispensing Isolator, where they are measured and dispensed into smaller containers, using inline sterile filters for a sterile transfer. These isolators are ideal for drug research and development laboratories that need to safely weigh and dispense Potent Active Pharmaceutical Ingredients (HPAPIs.)
2. Sterility Testing Isolators
These isolators allow operators to perform sterility tests in an aseptic environment and ensure process integrity. The superior testing results have not only increased laboratory testing confidence but have also decreased overall operation costs. As Sterility Testing Isolator Manufacturers, we provide a controlled means of loading and removing the processed product and waste materials from the isolator enclosure.
3. Mobile Isolators
FaBL's Mobile Isolators are ideal for scenarios where the work environment is not confined to a single location or when materials must be transferred from one aseptic isolator to another. They offer product protection in low-critical operations.
4. Filling Isolators
Parenteral drug filling demands bioburden-free aseptic environments to achieve product sterility, integrity, and safety. FaBL’s Aseptic Filling isolators enclose the filling lines for batch production of Vials/PFS/Cartridges with ISO 5 Grade A unidirectional airflow within the working chamber. These are dedicated air handling units with 80-20 or 90-10 air circulation. These are widely utilized in various container formats for the aseptic pharma production process.
All systems are compatible with VHP decontamination to achieve an aseptic environment and process integrity.
FabL is a leading pharmaceutical and containment isolator manufacturer, providing specialized technologies engineered to create and maintain a validated sterile environment. These isolators provide a well-contained barrier that ensures product manufacturing occurs under strict contamination-preventive conditions. With an ISO Class 5 / Grade A environment, FabL’s isolators guarantee the sterility of the work zone for critical sterile and aseptic operations.
The design of FabL's aseptic isolators prioritizes ease of monitoring and documentation, making them indispensable in environments where rigorous validation and qualification are essential to meet stringent regulatory standards. As a trusted clean-air solution, our isolators maintain the highest levels of sterility and integrity, ensuring that your aseptic processes remain consistently secure and compliant with pharmaceutical and biotechnology regulations.
Elevate your pharmaceutical and biotech operations with FabL's state-of-the-art aseptic isolators. Partner with us to ensure your projects operate at the highest standards of sterility and efficiency.
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