Vaccines such as the flu shot or mennigitis are manufactured in GMP controlled cleanrooms continuously validated following ISO 14644 Cleanrooms and Associated Controlled Environments. Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1. A contaminated vaccine voids the effectiveness of the vaccine intent and the batch is destroyed.

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