Global Quality Standards Compliance
All lyophilizers consist of 316L stainless steel and FDA seals, complying to CE, ISO 9001 and cGMP. Hygiene standards are achieved through the implementation of clean in place systems eliminating cross contamination. For pharmaceutical usage, there are optional sterile filtration modules and validation packages supporting FDA, EMA, and NMPA applications. The machines have certification for more than 50 countries including some with strict regulations such as the EU and Japan.
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