Pharmaclean® by AM Instruments sterile dressing kit: the quick and safe solution for cleanroom operators
Pharmaclean®, AM Instruments' cleanroom production dedicated to packaging for sterilization processes, supports customers through specific services such as repackaging for pharmaceutical applications and packaging of disposable dressing kits. The experience gained over the years, the constant contact with the customer and the team's expertise make the Pharmaclean® unit an integral part of the pharmaceutical supply chain, with production and service designed around the operational and quality needs of the Life Sciences sector.
Specifically, the dressing kits, made of Dupont™ Tyvek® material, contemplate sterile scabbard with integrated face mask, sterile aseptically folded hoodless coveralls, and sterile non-slip socks; each component of the kit is individually bagged and the three parts are packaged in a single polyethylene bag. The service consistently speeds up the customer's goods entry process and allows the operator quick and safe dressing while minimizing the risk of contamination and optimizing dressing time.
Tyvek® material ensures low particle release, with no fraying phenomena and is free of inherent contaminants that could pose a risk in contamination-controlled environments. Also being halogen-free, Tyvek® garments can be disposed of following standard processes.
The garments in the kit ensure high levels of quality, comfort, breathability and protection in order to meet regulatory requirements and the needs of pharma customers.
Packaging takes place in AM Instruments' Grade C Operational cleanroom , an area subjected to particle and microbiological monitoring in accordance with ISO14644-1 and Annex 1 (§9) to ensure that the cleanroom and equipment maintain an environment with adequate air cleanliness, in accordance with design and regulatory requirements, and effectively detects any deviations from environmental limits by performing investigations and risk assessments for product quality.
