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Updated: May 8, 2026
09:30
Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Tips for cleanroom construction and renovation.
1The Compounding Pharmacy, Hickory, North Carolina.
International Journal of Pharmaceutical Compounding
|August 24, 2013
Summary
Compounding pharmacies must build cleanrooms to meet United States Pharmacopeia (USP) 797 guidelines for sterile preparations. This report highlights using local mechanical contractors for custom cleanroom construction and cost control.
Area of Science:
- Pharmacy compounding
- Cleanroom technology
- Regulatory compliance
Background:
- Pharmacies increasingly need cleanroom upgrades to comply with United States Pharmacopeia (USP) Chapter 797 guidelines for sterile preparations.
- Traditional cleanroom construction often involves large engineering firms or specialized companies.
- Local mechanical contractors with design capabilities are an underutilized resource for custom cleanroom projects.
Purpose of the Study:
- To describe the successful installation of a state-of-the-art cleanroom in a busy pharmacy.
- To provide guidance for compounding pharmacists on selecting qualified local contractors.
- To offer strategies for managing the costs associated with cleanroom construction and upgrades.
Main Methods:
- Case study of a cleanroom installation in a community pharmacy.
- Discussion of contractor selection criteria and cost-control measures.
- Highlighting the benefits of utilizing local mechanical expertise.
Main Results:
- Successful implementation of a customized cleanroom facility.
- Demonstrated ability to achieve Pharmacy Compounding Accreditation Board (PCAB) accreditation post-installation.
- Identification of key factors for successful project execution and cost management.
Conclusions:
- Local mechanical contractors offer a viable and valuable resource for custom cleanroom construction in pharmacies.
- Strategic selection of contractors and cost management are crucial for successful pharmacy facility upgrades.
- Cleanroom compliance enables pharmacies to achieve higher standards of accreditation and patient safety.
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