Pass Box
A cleanroom pass box for pharmaceutical applications is an enclosed transfer chamber that allows materials to move between areas of different cleanliness levels without personnel movement. It acts as an airlock, reducing cross-contamination and maintaining cleanroom integrity.
These systems are used in pharmaceutical and laboratory environments to ensure safe material transfer and support GMP-compliant operations.
Key Features
- Enclosed chamber for material transfer
- Prevents cross-contamination between zones
- Maintains cleanroom integrity
- Suitable for different cleanliness classifications
- Supports GMP-compliant environments
Frequently Asked Questions
A pass box (transfer hatch) is an interlocked enclosure built into cleanroom walls, allowing materials to be transferred between areas of different cleanliness grades without direct room-to-room access. In pharmaceutical manufacturing, pass boxes prevent contamination from lower-grade areas entering higher-grade cleanrooms, maintaining GMP-required air quality and sterility assurance.
A static pass box uses only interlocked doors for isolation with no active airflow—suitable for transfers between similar cleanroom grades. A dynamic pass box incorporates HEPA-filtered laminar airflow inside the chamber, actively purging particles during transfer—required for material movement between unclassified areas and ISO Class 5–7 GMP cleanrooms.
Pass boxes use electromagnetic or mechanical door interlocks that prevent both doors from opening simultaneously, maintaining physical separation between cleanroom grades. Dynamic models add HEPA-filtered airflow to purge airborne contamination from transferred items before cleanroom entry, protecting critical zones from particle and microbial ingress during material transfer operations.
Yes. EU GMP Annex 1 and FDA aseptic guidelines require material transfer between cleanroom grades to maintain contamination control. Dynamic (HEPA-filtered) pass boxes are mandatory for transfers into Grade B and Grade A environments, as they provide active particle removal and maintain the pressure differential between classified areas during the transfer process.
GMP-compliant pass boxes are manufactured from 304 or 316L stainless steel with smooth, mirror-polished internal surfaces, coved corners, and no crevices where particles or microorganisms can accumulate. Exterior panels are typically powder-coated steel. All materials must withstand repeated cleaning with IPA, VHP, and other pharmaceutical disinfectants without degradation.
Pass box interlocks are either mechanical (gravity-based key-exchange) or electronic (electromagnetic solenoid-controlled). The system ensures only one door can open at a time—when one side is open, the opposing door is locked. This maintains the cleanroom's pressure differential, preventing unfiltered air from the lower-grade side from entering the controlled environment.
A properly designed and qualified dynamic pass box maintains ISO Class 5 (GMP Grade A) conditions inside the transfer chamber during operation. HEPA-filtered laminar airflow at the recommended velocity of 0.36–0.54 m/s ensures particle counts remain below 3,520 particles/m³ at ≥0.5 µm throughout the material transfer cycle.
Yes. Cleanroom pass boxes are fully qualifiable under IQ/OQ/PQ protocols. IQ verifies construction and installation; OQ confirms interlock function, airflow velocity, HEPA integrity, and pressure differential performance; PQ demonstrates sustained ISO Class 5 conditions during simulated material transfers. Full validation documentation supports GMP regulatory inspection and drug product approval submissions.
Yes, all our products are designed and sourced to meet international regulatory standards, including GMP, USFDA, EU-GMP, WHO, and other relevant compliance requirements.
Absolutely. Our solutions are engineered for seamless integration with existing systems, ensuring minimal disruption and optimal performance within your current setup.
Yes, our team offers technical consultation to help you choose the most suitable product based on your process requirements, facility design, and compliance needs.
Yes, all our products are aligned with our turnkey execution approach, ensuring compatibility with overall facility design, engineering, and operational requirements.
Yes, we provide customised solutions tailored to your process, capacity, and regulatory requirements to ensure optimal performance and efficiency.
Our products are used across pharmaceutical manufacturing, biotechnology, nutraceuticals, research laboratories, and regulated healthcare environments.
We follow strict quality standards and work with trusted technologies and manufacturing processes to ensure consistent performance, durability, and compliance.
Yes, we offer ongoing technical support to ensure smooth operation, performance optimisation, and long-term reliability of all supplied systems and components.
