Risk and science-based validation of cleanroom garments

Important quality attributes of cleanroom garments that are worn during the manufacture of sterile medicines include; cleanliness, sterility, particle and microbial filtration efficiency' durability and comfort. Important risk factors related to cleanroom garment systems include gowning processes and related activities, such as laundering, packing, sterilization, repairs, storage, handling and logistics, as well as change management. Because many factors contribute to the overall quality, adequacy and suitability of cleanroom garment systems, a thorough and focused validation of cleanroom garments is critically important.

After providing a review of current and emerging regulations and standards, the article proposes a risk and science-based quality-by-design approach for the development, implementation and validation of sterile cleanroom garment systems. With this approach, more effort is spent at the front-end during the design phase as well as during design qualification. This will lead to designed-in risk reductions, enhanced scientific knowledge on selected technical solutions and better awareness of limitations and residual risks. As a result, there should be fewer issues during cleanroom qualifications and process validations leading to more effective routine operations as well as improved patient safety. The proposed approach, if implemented correctly, is not only the correct strategy to effectively control contamination risks related to people but also an adequate response to the latest regulatory requirements,

This is an extract from an article by Milenko Pavicic and Thierry Wagner in the Cleanroom and Containment Review (CACR) issue 39, to read more subscribe now