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Validation study: testing autoclavable cleanroom goggles

机译:验证研究:测试可高压灭菌的洁净室护目镜

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摘要

With regard to the changes in GMP Annex 1, which will come into force in August 2023, and the importance of wearing autoclavable cleanroom safety goggles in sterile environments, it is now necessary to deal more intensively with this topic. CWS Cleanrooms, as a full-service partner around the cleanroom, has also dealt with this topic in detail and, together with the manufacturer Bolle Safety, carried out an initial validation study over a one-year period. Seven cleanroom goggles were systematically tested for their material resistance and the maximum washing and sterilisation cycles. Here are the results:Protective goggles are necessary in the cleanroom area. On the one hand, to minimise contamination of products and processes by, for example, human skin flakes, microorganisms, particles and droplets from the facial area. On the other hand, however, they are also needed to protect employees in cleanroom laboratories from chemicals, vapours or splinters, for example. Quality assurance in cleanrooms is always of particular importance. Not only in sterile areas, processes and manufacturing must be carried out carefully and according to validated methods. Thus, addressing this issue is worthwhile for the different cleanroom classes and environments.
机译:关于将于 2023 年 8 月生效的 GMP 附录 1 的变化,以及在无菌环境中佩戴可高压灭菌洁净室安全护目镜的重要性,现在有必要更深入地处理这一主题。CWS洁净室作为洁净室的全方位服务合作伙伴,也详细处理了这一主题,并与制造商Bolle Safety一起进行了为期一年的初步验证研究。对七种洁净室护目镜进行了系统测试,测试了其材料耐受性以及最长的洗涤和灭菌周期。结果如下:洁净室区域需要护目镜。一方面,尽量减少对产品和工艺的污染,例如人体皮肤薄片、微生物、颗粒和面部飞沫。然而,另一方面,它们也需要保护洁净室实验室的员工免受化学品、蒸汽或碎片的侵害。洁净室的质量保证始终尤为重要。不仅在无菌区域,还必须按照经过验证的方法仔细进行工艺和制造。因此,对于不同的洁净室类别和环境来说,解决这个问题是值得的。

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