Guidance for Cleanroom Pass Throughs in cGMP Cell and Gene Therapy Facilities

Cell and gene therapy facilities require stringent material control measures to prevent contamination and ensure the safety of patients. In traditional pharmaceutical facilities large material airlocks act as an intermediate space between cleanrooms or between a cleanroom and a non-controlled environment. In contrast, cleanroom active pass-throughs are designed to streamline the transfer process, providing a more compact and efficient solution. By offering an enclosed space to move materials between environments, pass-throughs minimize the risk of contamination while maintaining a cleanroom’s air pressure and airflow requirements. Additionally, pass-throughs are more space-efficient than material air locks, reducing the overall footprint required for material transfers.

Active HEPA purging pass-throughs provide several benefits for material control in cell and gene therapy facilities. One major advantage is that they minimize the need for personnel to enter and exit controlled environments. This reduces the risk of contamination and also minimizes disruptions to ongoing operations.

Another advantage of active purging pass-throughs is that they provide a highly controlled environment for material transfer. HEPA filters ensure that the air passing through the pass-through is free of contaminants, while positive pressure purging removes any contaminants that may be present on the surface of the material being transferred.

Pass-throughs should be used to pass material from one classified space to another like from Grade C to Grade B. If a pass-through is used for waste transfer on the exit going from Grade B to D may be appropriate.

To keep the environments of both rooms separate, pass-throughs employ the use of timed interlocks that prevent the doors from being opened during a purge cycle. The purge time is usually set during particulate studies to ensure the purge cycle dilutes potential airborne contaminants effectively.

Active purging pass-throughs fall into one of three categories depending on the type of risk of contamination and biocontainment level.

• Exhausted extraction systems are generally used to prevent particulates from exiting through the pass-through doors. Pass-thoroughs of this type are commonly used in biocontainment applications.
• Supplied pass-throughs have an attached air-supply system that prevents particulates from entering. This approach requires one or both rooms to leak into the box.
• Internally recirculated pass-throughs have an internal supply that reduces particulate concentrations within the pass-through box. This type of pass-through does not affect room pressure differentials.

Active purging pass-throughs in high containment environments like biosafety level three (BSL3) facilities, not only protect the product with HEPA filtered air, they also support containment by HEPA filtering air being exhausted from the pass-through. Pass-throughs in facilities requiring containment can also have integrated biodecontamination systems using vapor hydrogen peroxide for instances where the risk of contamination has a greater impact on product or personnel.

Active purging pass-throughs use a combination of HEPA filters and a blower system to create a highly controlled environment for material transfer. The blower system creates a positive pressure for typical cleanrooms or a negative pressure environment for containment facilities. Pressure and HEPA filtered air helps to remove any contaminants that may be present on the surface of the material being transferred.

Germfree Laboratories’ mobile and modular facilities are outfitted with integrated active HEPA purging pass-throughs to facilitate the transfer of materials without the need for personnel to enter and exit controlled environments, reduce the risk of contamination and improve efficiency. Germfree Laboratories’ active purging pass-throughs are designed fit-for-purpose and can be easily integrated into existing facilities. They are available in a range of sizes to accommodate different types and sizes of materials, and can be customized to meet the specific needs of a facility.

In conclusion, Germfree Laboratories’ active purging pass-throughs offer an even higher level of material control for cell and gene therapy facilities. They minimize the need for personnel to enter and exit controlled environments, provide a highly controlled environment for material transfer and can support the protection of product and reduce the risk of contamination in facilities requiring containment. Facilities that require stringent contamination control measures should consider the advantages of HEPA purging pass-throughs to improve safety and efficiency.