Building a GMP Facility: 8 GMP Cleanroom Requirements

A pass-through cabinet is an enclosure installed in a wall between two or more adjacent spaces to facilitate the transfer of materials from one side of the cleanroom to the other. In other words, it&#;s a smaller airlock inside the wall to transfer material only. The same requirements for MALs, PALs, and doors are necessary for the pass-through to be GMP compliant.

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4. Interlocking System

The entries, personnel airlocks, material airlocks, and pass-throughs need to have an interlocking system to be GMP compliant.

The interlocking system is to render the opening of more than one door at a time impossible. In a regulated environment, such as a cleanroom, interlocking systems are designed to provide a safe, efficient, and easy way of opening and closing doors.

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Without this system, when both doors are open, it creates a wind corridor, pushing the microorganisms and airborne particles to the cleaner side of the cleanroom. This could be the difference between remaining GMP compliant or not.

An interlock door system will minimize the loss of pressure that happens when two doors are opened simultaneously and allow the HVAC to work in optimal conditions for maintaining the required cleanliness level. This feature will preserve air quality and prevent outside airborne contaminants from entering the manufacturing cleanroom area.

The interlocking door system is not an obligation under the GMP guidelines for sterile drug products, but it is mandatory that two doors cannot be opened simultaneously. A visual and/or audible alarm or signal could be another option to replace the interlocking system.

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