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Products manufactured as an aseptic parenteral have the greatest risk of contamination and must be manufactured in an area tolerating only the lowest level of risk.

In critical areas, such as Class 100 or ISO 5 (the area in immediate proximity of exposed sterilized containers/closures and filling/closing operations), the particle per cubic meter must be no more than 3520 particles/m in a size of 0.5 micrometers or larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations.

In critical areas such as Class 100 or ISO 5 (area in immediate proximity of exposed sterilized containers/closures and filling/closing operations), the particle per cubic meter must be no more than 3520 particles/m in a size of 0.5 micrometers or larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations.

Supporting areas, or clean room areas where the laminar flow stations are located, must meet at least Class 100,000 (ISO 8) air quality. The nature of your activities conducted in a supporting clean room area determines its classification.

Sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles.

USP 797 provides guidelines, procedures and compliance requirements for compounding sterile preparations.

The following USP 797 Q&A helps answer your questions.

USP 797 refers to chapter 797 "Pharmaceutical Compounding – Sterile Preparations," in the USP National Formulary.

It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).

USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

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