This overview of Cleanroom Validation Testing for Medical Device Manufacturing draws upon our experience validating a Class 7 Cleanroom.

A highly regulated environment, like that of a ISO 13485:2016 certified medical device manufacturer, requires assurance that critical processes can be performed within a controlled environment.

Cleanrooms control and maintain a stable manufacturing environment for products that require little to no contamination from external material.

The Basics of Cleanroom Validation Testing

When you think of cleanrooms, you usually think of a closed off white room with people dressed in gowns a wearing mask, and gloves doing R&D or manufacturing. For the most part that is correct.

Cleanroom is a pretty broad term, but generally it just means a room that is cleaner than a regular room. They are kept clean using a variety of filters in a pressurized room, consistent temperature and the individuals who work in them wear protective clothing to prevent contaminating the room with foreign particulates.

The ISO 14644-1 defines the class of cleanliness required by manufacturers and the tasks associated with process validation.

Cleanroom classes range from ISO 1 to ISO 9. ISO 1 being the “cleanest” class and ISO 9 is the “dirtiest” class. Even if it’s classified as the “dirtiest” class, the ISO 9 clean room environment is again cleaner than a regular room.

The most common ISO clean room classes are ISO 7 and ISO 8;

ISO 7 | 30–60 air changes per hour and maintains air cleanliness levels of a maximum of 10,000 particles

ISO 8 | 15–25 air changes per hour (ante-room) and maintains air cleanliness levels of maximum of 100,000 particles

Building and Validating our Toronto Cleanroom

HEPA Validation and Cleanroom Validation Testing

H.E.P.A. (High Efficiency Particulate Air) filters are the primary component requiring validation in a cleanroom. Validation is conducted through a filter integrity test. H.E.P.A. filters are made out of a boron silicate microfibre manufactured paper. It is a very delicate material and is very susceptible to either physical damage or leaks due to wear and tear from pressures and stresses caused by daily operation in the cleanroom. The particle sizes that H.E.P.A. filters are designed to trap are very small, and even small holes in the filter or leaks on the gaskets, frame, or seals can cause substantial damage to products being worked on within the cleanroom.

A H.E.P.A. filter leak test is important to pinpoint and correct H.E.P.A. filter performance problems before they can escalate to a point where they cost the user both time and money on failed experiments or projects. These filters should also be replaced periodically to ensure the room maintains its specified level of cleanliness.

Air Flow Validation

An Air flow test in cleanrooms is as important as the filter integrity tests. Verifying the air flow (velocity, volumetric flow, directional flow, refluxing etc.) ensures that adequate flow of unidirectional air (“laminar flow”) or non-unidirectional flow for the purpose of particle dilution is being achieved in the cleanroom. Also, cleanroom users should have assurance that air flow is directionally controlled, or that air flow is not being deflected or redistributed to areas of the cleanroom where contamination can result from air flow problems including air current refluxing, dead spots, or turbulence.

Particle count validation