In controlled environments such as pharmaceutical, semiconductor, and biotechnology cleanrooms, preventing cross-contamination during material transfer is a top priority. A cleanroom pass box serves as a secure interface between classified areas, allowing the safe movement of tools, raw materials, and samples while maintaining environmental integrity.
AGMM TECH designs and manufactures high-performance cleanroom pass boxes that support GMP compliance, minimize human intervention, and protect critical processes. In this article, we’ll define what a cleanroom pass box is, explore its different types, highlight the benefits for contamination control, explain how pass trolleys enhance cleanroom logistics, and present AGMM TECH’s specialized solutions.
What is a Cleanroom Pass Box?
A cleanroom pass box, also known as a pass-through chamber, is a closed, self-contained device installed in a wall or partition between two cleanroom zones. Its primary function is to enable the safe transfer of materials—such as tools, raw ingredients, samples, or components—from one classified area to another without requiring personnel movement. This significantly reduces the risk of contamination and maintains the cleanroom’s environmental integrity.
Pass boxes operate on the principle of airlock isolation. They are equipped with interlocking doors—a safety feature that ensures only one door can be opened at a time. This prevents air exchange between different cleanliness levels and helps preserve pressure differentials critical to contamination control. In high-grade cleanrooms, where even minor pressure shifts can lead to particle infiltration, this feature is essential.
Internal surfaces of the pass box are constructed from non-porous, non-shedding, and chemically resistant materials such as stainless steel. Rounded corners and smooth finishes reduce particle accumulation and simplify cleaning. For enhanced contamination control, some models are equipped with HEPA or ULPA filters, UV-C sterilization, differential pressure indicators, or even integrated air showers to purge particulates during material transfer.
In GMP and ISO-classified environments, pass boxes help streamline workflow by eliminating the need for repeated gowning, hand hygiene, and zone requalification procedures. They support both product safety and operator efficiency, making them an indispensable component of modern cleanroom design. Whether installed between two clean zones or between a clean area and an external corridor, the pass box functions as a physical and operational barrier—preserving cleanliness, controlling bioburden, and improving process flow.
Types of pass boxes and pass-through systems
Different cleanroom processes and layouts require tailored transfer solutions. Pass boxes are generally classified into two main categories based on airflow: static and dynamic. Each serves distinct operational needs and cleanroom standards.
Static Pass Boxes
Static pass boxes are used between areas of equal classification, such as ISO Class 7 to ISO Class 7, where no airflow regulation is required. They act purely as a containment system to isolate the external environment during the opening of either door.
Key features:
- No built-in ventilation or filtration systems
- Suitable for transferring non-sensitive materials
- Minimal energy consumption
- Cost-effective solution for same-class transfers
- Interlocked doors ensure contamination isolation
Static pass boxes are ideal for transferring tools, documents, packaging materials, or supplies where airborne contamination is not a significant risk.
Dynamic Pass Boxes
Dynamic pass boxes include integrated HEPA or ULPA filtration and maintain unidirectional airflow within the chamber. These units are used between zones of different classifications—for example, from an ISO Class 8 corridor to an ISO Class 6 cleanroom—where controlled airflow is needed to protect product or process integrity.
Key features:
- Recirculating or once-through HEPA-filtered airflow
- ISO Class 5 environment inside the pass box
- Prevents bi-directional contamination
- Often includes UV sterilization, pressure gauges, and alarm systems
- Compliant with GMP and ISO 14644 guidelines
Dynamic pass boxes are used for transferring sterile components, raw materials, or intermediate products between unclassified or lower-class areas and high-grade cleanroom.
Benefits for contamination control and workflow efficiency
Cleanroom pass boxes provide essential contamination control and operational advantages, especially in facilities with stringent cleanliness requirements such as pharmaceutical manufacturing, semiconductor production, and medical device assembly. Their integration into cleanroom infrastructure supports both process integrity and regulatory compliance.
Key benefits include:
- Minimized Cross-Contamination Risk:
Interlocking doors and internal filtration systems prevent simultaneous access to both sides of the pass box, isolating clean zones and significantly reducing the likelihood of airborne particle migration between different ISO classifications or GMP grades. - Maintained Pressure Differentials:
Cleanroom zoning often relies on positive or negative pressure differentials to control airflow direction. Pass boxes help maintain these differentials by limiting uncontrolled openings and protecting the barrier between zones. - Reduced Personnel Traffic:
By enabling material transfers without requiring operators to physically move between rooms, pass boxes reduce foot traffic and limit the need for repeated gowning and de-gowning—two activities known to generate particulates. - Enhanced Operational Efficiency:
Transfers that might otherwise involve multiple steps or personnel can be handled quickly and securely, optimizing process flow, reducing bottlenecks, and improving productivity across critical production lines. - Support for GMP and ISO Compliance:
The hygienic design, easy-to-validate operation, and contamination control functions of pass boxes align with EU GMP Annex 1, FDA guidance, and ISO 14644 standards. They simplify documentation and support audit readiness. - Improved Traceability and Risk Management:
Advanced models can be equipped with access control systems, cycle counters, or digital logging to document usage and reinforce SOPs related to material handling and segregation.
These benefits are particularly valuable in environments where sterility, traceability, and product integrity are non-negotiable. In such settings, pass boxes contribute to a controlled, validated workflow—ensuring that every material entering or exiting a critical clean zone does so without compromising the environment or the process.
Integration of pass trolleys in Cleanroom environments
While pass boxes ensure safe hand-off between zones, pass trolleys facilitate the secure internal transport of materials once inside the cleanroom. When integrated into a comprehensive material transfer strategy, pass trolleys offer ergonomic and contamination-controlled mobility.
Features of cleanroom pass trolleys:
- Constructed from stainless steel with smooth, rounded edges
- Electro-polished for ease of cleaning and sterilization
- Antistatic wheels and non-shedding components
- Custom shelf configurations and handles for material-specific needs
- Compatible with pass boxes to streamline loading/unloading
In facilities with multiple clean zones or long process lines, pass trolleys reduce manual handling, speed up internal logistics, and maintain GMP compliance by avoiding unnecessary contact and exposure.
When pass boxes and pass trolleys are used in tandem, material transfer becomes a fully controlled and efficient process—ensuring a clean, traceable path from entry to production.
AGMM TECH Solutions for material transfer in cleanrooms
AGMM TECH provides fully customizable cleanroom pass boxes and pass-through systems, designed to meet the highest standards of hygiene, efficiency, and compliance. With a deep understanding of GMP workflows, ISO 14644 standards, and the technical demands of critical industries, our systems deliver reliability and operational value.
Why choose AGMM TECH pass box solutions:
- Custom-Built Configurations: Available in a range of sizes, finishes, and airflow options (static, dynamic, hybrid) tailored to your layout.
- ISO Class 5 Environments: Our dynamic pass boxes include high-performance HEPA filters and airflow systems that ensure ultra-clean internal conditions.
- GMP-Ready Designs: All models are engineered for seamless cleanability, hygienic design, and easy validation.
- Advanced Features: Options include UV-C sterilization, differential pressure control, status indicators, and automated logging.
- Integrated Trolley Compatibility: Designed with ergonomics and mobility in mind, our systems align with cleanroom transport workflows.
- Full Project Support: From initial specification to installation, documentation, and after-sales service, AGMM TECH provides end-to-end support for your cleanroom operations.
Whether you’re upgrading a single clean zone or implementing a multi-room material transfer strategy, AGMM TECH delivers trusted solutions that ensure sterility, efficiency, and peace of mind.
Conclusion
A cleanroom pass box is a cornerstone of contamination control in regulated environments, allowing safe and efficient material transfer without compromising classified zones. Whether using static or dynamic systems, integrating pass boxes into your cleanroom ensures smoother workflows, reduced risks, and better compliance outcomes.
With AGMM TECH, companies gain access to expertly engineered pass-through solutions backed by deep industry knowledge and reliable customer support. Our cleanroom pass boxes and trolleys are designed to meet the operational demands of pharmaceutical, biotech, microelectronics, and high-purity manufacturing facilities.
