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Published on: August 3, 2016
Implementation of a viable air-sampling program using a volumetric collection device.
Steve Kennedy1, Lisa Linn Siefert, Matt Lange
1Walgreens. Buffalo Grove, IL.
International Journal of Pharmaceutical Compounding
|August 23, 2013
Summary
Implementing United States Pharmacopeia (USP) Chapter <7797> viable air sampling requires careful consideration of various methods. This organization evaluated key factors, implementation challenges, and outcomes for in-house testing.
Area of Science:
- Pharmaceutical Sciences
- Environmental Monitoring
- Quality Control
Background:
- United States Pharmacopeia (USP) Chapter <7797> outlines standards for viable air sampling.
- Infusion pharmacies require robust environmental monitoring to ensure product safety.
- Various methods exist for implementing USP Chapter <7797> air sampling.
Purpose of the Study:
- To review factors for developing a viable air sampling program.
- To discuss challenges encountered during implementation.
- To present results of an in-house air sampling testing decision.
Main Methods:
- Review of factors influencing air sampling program development.
- Analysis of implementation challenges in a multi-site infusion pharmacy.
- Evaluation of outcomes from adopting in-house viable air sampling.
Main Results:
- Identification of critical factors for successful air sampling program design.
- Documentation of common hurdles in implementing USP <7797>.
- Assessment of the feasibility and results of in-house testing.
Conclusions:
- Strategic planning is crucial for effective USP <7797> viable air sampling implementation.
- Addressing challenges proactively can streamline the process.
- In-house testing offers a viable approach for compliance and quality assurance.
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