Our website offers useful information for getting and staying USP <797> compliant. See USP <797> revisions for November 2023. This guide serves as an overview to these resources. Our trained cleanroom consultants can assist you with questions about your specific protocols especially if you are facing issues with contamination or product incompatibility. Just ask!
USP <797> Cleaning & Disinfecting Compounding Areas
Your cleanroom’s standard operating procedure guides your protocols. But as a guideline, the following areas should be cleaned and disinfected as described below at a minimum. See our pharmacy cleanroom cleaning guide with checklists for more details.
Primary Engineering Controls (PEC) except Isolators
Regular intervals
- Beginning & end of each shift
- Before each batch
- During continuous compounding, at least every 30 minutes
Additional cleaning/disinfection cycle
- After a spill
- Anytime surface contamination is suspected or confirmed
Isolators
- Clean each time it is opened
- Disinfect once it closed each time it is opened or after each cleaning cycle completed without opening the unit.
Outside the PEC
- Work surfaces outside the PEC, e.g., buffer area and/or segregated compounding area) – Daily
- Floors – Daily
- Walls – Monthly
- Ceiling – Monthly
- Storage Shelves/Cabinets – Monthly
USP <1072> Disinfectant Classification
See the below chemical entity classifications with our recommended products for most compounding pharmacy cleanrooms. Browse our most popular cleanroom cleaning chemicals.
- Alcohols – General purpose disinfectant, antiseptic, and anti-viral agent Recommended: Cidehol ST 70 IPA
- Chlorine & Soda Hypochlorite – Sporicidal agent
Recommended: Decon Spore 200 Plus - Phenolics – General purpose disinfecting agent
Recommended: Decon-Phene - Hydrogen Peroxide – Vapor phase sterilant, liquid sporicidal agent, antiseptic
Recommended: Steri-Perox - Sterile Water – Universal cleaning solution and diluent for cleanrooms
Recommended: Steri Water - Quaternary Ammonium – General purpose disinfectant
Recommended: Decon Quat 200C
Minimum Apparel Requirements
Below is an overview of minimum garbing requirement for USP 797 compliance.
Disposable coveralls or gown
- Sterile: DuPont IsoClean Sterile Coveralls
- Non-sterile: Enviroguard MicroGuard MP Coveralls
Disposable shoe covers
- Sterile: GammaGuard CE Sterile Shoe Covers
- Non-sterile: Blue Polypropylene Anti-Skid Shoe Covers
Disposable bouffant and beard covers
- Sterile: DuPont IsoClean Sterile Bouffant Cap
- Non-sterile: Criti Clean Polypropylene Bouffant
Sterile gloves
Sterile facemask
Sterile goggles
Ask Our USP <797>Experts
Have questions about USP 797 compliance or what cleanroom apparel is right for your environment?
Ask our cleanroom consultants.
They will help you choose the products that match your protocols and will provide free samples to help you ensure they work in your environment.
