Pharmacy Support Services
National Air Filter has extensive experience in providing support services to Pharmacies needing to comply with USP <797> "Pharmaceutical Compounding". We can test, certify, and provide evidence that your facility meets the expectations of the USP guideline. These requirements include:
- The direct compounding area [DCA] is inside an ISO Class 5 (or better) Laminar Airflow Cleanbench. NAF can assist you in assuring that this cleanbench meets USP <797> certification standards every six months.
- Your ISO Class 5 cleanbench must be operated within a cleanroom (buffer area) that meets ISO Class 7. Supply air HEPA filtration is required for the Class 7 area. This cleanroom also requires semiannual certification.
- Cleanbench blowers must be operated continuously during all compounding activity and periods of inactivity lasting less than eight hours.
- If the blower has been disengaged during a period of inactivity exceeding eight hours, only one operator may enter the cleanroom for the purpose of activating the blower and conducting aseptic cleansing of the DCA. Ingress may be granted to additional personnel once the blower has been active for a minimum of thirty minutes.
- The following may be used as acceptable alternatives to a laminar airflow cleanbench: biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators.
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