What is USP 797 cleanroom?
USP 797 is a standard for sterile compounding practices established by the United States Pharmacopeia (USP). A USP 797 cleanroom refers to a clean environment that meets the requirements of this standard, primarily used for the production and preparation of sterile pharmaceuticals, ensuring drug quality and patient safety. The standard provides clear regulations on cleanroom design, facilities and equipment, operating procedures, cleaning, and maintenance to ensure that production activities conducted within the cleanroom meet specific hygiene standards and cleanliness requirements. Furthermore, the cleanroom's classification and design must be determined based on specific production needs and product characteristics.
USP 797 cleanrooms are widely used in hospitals, compounding pharmacies, outsourcing facilities, and healthcare institutions where sterile drug compounding is performed to ensure patient safety and regulatory compliance.
What are the basic compliance requirements for USP797 cleanroom?
1.Clean Environment Standard: Dispensing must be performed in an ISO class 8 (Federal Class 209E 100,000) controlled area. This requires the clean room to be equipped with an ultra-clean laminar flow bench, biological safety cabinet, or fully sealed glove box to provide ISO class 5 (Federal 209E Class 100) air quality.
2.Barrier System: In order to safeguard drug sterility, patient safety, and dispenser health, USP 797 recommends the use of positive-pressure glove-boxes with a fully sealed design in cleanrooms. The glove box provides a physical barrier between the dispensing personnel and the dispensing area, helping to minimize the risk of contamination.
3.Risk level management: USP 797 categorizes sterile preparation mixtures into low, medium, and high risk levels and immediate use categories, specifying the conditions and management requirements for each category to ensure the safety and efficacy of the drugs.
4.Test methods: USP 797 also addresses test methods, including but not limited to microbiological tests, sterility tests, etc., to ensure that the drug product meets the sterility and cleanliness requirements.
5.International standards: In addition, USP 797 applies references from international standards such as EN 12469, a standard issued by the European Committee for Standardization, which covers performance requirements and test methods for biosafety benches and laminar flow hoods, particularly for application in biological laboratories.
USP 797 clean room temperature and humidity requirements
The USP 797 clean room should have unidirectional airflow device with sterilization and filtration function. In addition, indoor temperature of cleanroom should be 18-25 ℃ while relative humidity shoule be 45% -65%. Buffer room and operation room should be set up to achieve air disinfection effect by ultraviolet lamps or other suitable disinfection device.
USP 797 Required Certified Cleanroom Areas
ISO 7 / ISO 8 Buffer Room: Has the highest pressure to prevent airflow from other rooms and avoid cross-contamination.
ISO 7 / ISO 8 Ante Room
ISO 5 Critical Operation Area (environment where the PEC is located)
All areas are positive pressure control
USP 797 is primarily applicable to the preparation environment of sterile pharmaceutical formulations, emphasizing strict management of personnel behavior and operational procedures.
Its core features include:
● Each functional area must meet clearly defined cleanliness levels and differential pressure control requirements to prevent cross-contamination;
● Establishing standardized personnel and material flow paths to ensure the continuity and controllability of aseptic operations;
● Regularly monitoring the environment for microorganisms and implementing systematic cleaning and disinfection procedures to maintain long-term compliant operation.
AIRKEY Customized USP797 Modular Cleanroom Projects
