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Blueprint for implementing USP chapter 797 for compounding sterile preparations.
1Clinical IQ, LLC, 184 Columbia Turnpike #282, Florham Park, NJ, USA. ekastango@clinicaliq.com
Summary
Implementing United States Pharmacopeia (USP) chapter 797 for sterile compounding requires a methodical approach to ensure purity, potency, and sterility. Adherence to cleanroom standards and aseptic techniques is crucial for quality compounded sterile preparations (CSPs).
Area of Science:
- Pharmaceutical Compounding
- Sterile Preparation Quality Control
- Aseptic Technique
Background:
- Guidelines for adopting and implementing United States Pharmacopeia (USP) chapter 797 for compounding sterile preparations (CSPs) are presented.
- The quality of CSPs is directly linked to methods ensuring purity, potency, and sterility.
Framework:
- A properly designed, constructed, and maintained cleanroom is essential for CSP quality.
- Design criteria for cleanrooms and a comparison of liquid disinfectants for facility sanitization are provided.
- Documentation of all cleanroom activities, including air and surface sampling, is required.
Implementation:
- A robust employee-training program for aseptic technique and verification of personnel competency are integral to USP chapter 797 compliance.
- Emerging compounding and testing technologies are discussed to aid implementation.
Implications:
- Compliance with USP chapter 797, while potentially seeming overwhelming, can be achieved through a methodical and organized approach.
- Maintaining implemented systems requires vigilance and follow-up.
- Establishing USP chapter 797 compliance involves upfront and ongoing costs, but long-term maintenance is less resource-intensive than manual data systems.