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Contamination Risk Factors & Validation Stages for Sterile Garments
Humans are the biggest source of contamination in a cleanroom, making cleanroom apparel selection a critical consideration. With the 2020 draft revision of the European Union’s good manufacturing practices (GMP) Annex 1 and the eventual alignment with the US Food & Drug Administration guidelines, companies involved in sterile manufacturing are tasked with developing a contamination control strategy which includes a risk assessment.
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