Selection of protective products in accordance with GMP Annex 1.
Did you know that the biggest contamination factor in aseptic manufacturing is human movement? A practical guide to selecting protective products in cleanrooms.
This catalog is a white paper that provides a detailed explanation of the management of contamination risks from operators in a sterile environment, based on the requirements of the revised EU GMP Annex 1 (Manufacturing of Sterile Medicinal Products). It introduces key points for selecting appropriate protective clothing for cleanrooms and gloves for RABS/isolators. The revised Annex 1, issued in August 2022 and implemented in August 2023, emphasizes that "humans" are the largest source of contamination, highlighting the importance of managing operator behavior, attire, and the qualification assessment of PPE (personal protective equipment) more than ever before. This catalog organizes these regulatory backgrounds in an easy-to-understand manner and explains how to apply them in practical operations on-site.
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Ansell supports the safety of over 10 million people in more than 100 countries around the world, accumulating extensive experience, transparent data, and know-how through the provision of protective gloves, protective clothing, and solutions in various environments. Based on this, we anticipate our customers' needs and provide products and services that predict, prevent, and protect against risks in the workplace, thereby supporting the realization of a safe and sustainable work environment. In addition to Ansell's core brands such as HyFlex, BioClean, MICROFLEX, and AlphaTec, we will acquire Kimberly-Clark's personal protective equipment (KCPPE) business in 2024, adding the KIMTECH brand to our lineup. This will enable us to meet the increasingly diverse and sophisticated needs of customers in industries such as pharmaceuticals and semiconductor manufacturing.