USP 797 Clean Room Design and Construction By DESCCO
Pharmacies that prepare Compounding Sterile Preparations (CSPs) must follow standards created by the United States Pharmacopeia (USP) chapter 797.
The compounding facility must comply with clean room classifications as defined by the International Organization for Standardization (ISO) in order to create a safe, clean environment.
Primary Engineering Controls (PECs) must meet ISO 5 clean room requirements. This is commonly achieved with laminar airflow workbenches or compounding aseptic isolators that are located in an ISO Class 7 clean-rooms.
A compounding aseptic isolator (CAI) is positively pressured with HEPA filtered air and used for compounding non-hazardous drugs.
What Is USP 797?
USP 797 is a publication issued by the United States Pharmacopeia in order to improve the safety of the compounding environment and all the products made in that environment.
Sterile Compounding Facility Clean Room Requirements
Although the mandate to use a clean-room in a pharmacy is new, pharmacists were not previously required to work in a clean-room environment when compounding sterile preparation.
- ISO Class 8 Ante Room
- ISO Class 7 Clean room also called a Buffer Area
- ISO Class 5 Primary Engineering Controls located within the Buffer Area
- Proper clean rooms garments and hygiene procedures
- Temperature and humidity control to create comfortable work environment
- Air pressure differentials between rooms
- Airlocks and pass-through cabinets
- Construction materials that will provide a sanitary and easy to clean surface
- Certification to prove ISO requirements are achieved
- Continuous monitoring of air quality, scheduled cleaning and maintenance program
DESCCO’s Clean-Room Construction Services
Quality construction matters when building a compounding clean-room to USP 797 standards. Providing a clean, sterile environment for sterile compounding will help ensure the safety of your patients who require special medications.
DESCCO can help plan, budget, design, engineer, and construct your USP 797 clean room. Our team is very familiar with ISO clean room requirements and creating sterile environments for compounding medications.
DESCCO Design and Construction