At our Batang Kali cleanroom facility, ensuring the highest standards of garment integrity is our top priority. To maintain cleanroom compliance and ensure product safety, we have conducted thorough visual inspections of our garments and particle count tests (Helmke Drum Test) in accordance with the IEST-RP-CC003.3 standard.
To further ensure full compliance with Annex 1 regulations, we also validate our sterile and non-sterile garments. This includes determining the garments’ end-of-life at a set frequency, followed by gamma irradiation for sterilization. Our validation process is directly aligned with the guidelines outlined in Annex 1, part 7.11, which states:
“Garments should be visually checked for cleanliness and integrity immediately prior to and after gowning. For sterilized garments and eye coverings, particular attention should be paid to ensure they have undergone the sterilization process, are within their specified hold time, and that the packaging is visually inspected to ensure it is intact before use. Reusable garments (including eye coverings) should be replaced if damage is identified, or at a set frequency determined during qualification studies. The qualification of garments should consider any necessary garment testing requirements, including damage to garments that may not be identified by visual inspection alone”
In conclusion, our rigorous validation process is essential not only for maintaining garment sterility and integrity but also for ensuring full compliance with Annex 1 requirements. By following these guidelines, we safeguard product quality and protect product safety while adhering to the best practices required for cleanroom environments.
