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USP 797 Guidelines for Primary Engineering Controls (PEC)

Daily Cleaning of ISO 5 Laminar Flow Hoods, Biological Safety Cabinets and other PEC (Primary Engineering Controls)

Minimum Frequency for Cleaning Primary Engineering Controls

  • Beginning of each shift
  • Before each batch
  • Every 30 minutes while compounding
  • As spills occur
  • When surface contamination is suspected

 

Recommended Contec Healthcare products:

ToolsSolutionsWipes
EasyReach Cleaning Tool Contec Sterile 70% Alcohol PROSAT Sterile PS-911EB Presaturated IPA wipes
  PeridoxRTU Sporicidal Disinfectant and Cleaner SterileSorb Dry Wipes
  PREempt RTU Disinfectant Solution Amplitude EcoCloth Dry Wipes 
    Amplitutde Kappa Sterile LE Wipes

What the USP 797 Guidelines for Engineering Controls say:

From page 15 of the chapter, “Cleaning and disinfecting surfaces in the LAFWs, BSCs, CAIs, and CACIs are the most critical practices before the preparation of CSPs. Consequently, such surfaces shall be cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods of individual CSPs, when there are spills, and when surface contamination is known or suspected from procedural breaches.”

The chapter also requires that this be done with a “residue free disinfecting agent such as Sterile 70% IPA which is allowed to dry before compounding begins.” And…. “When sterile supplies are received in sealed pouches designed to keep them sterile until opening, the sterile supplies may be removed from the covering pouches as the supplies are introduced into the ISO Class 5 (see Table 1) PEC (LAFW, BSC, CAI, CACI) without the need to disinfect the individual sterile supply items.”

Page 15 of the USP Chapter states that the disinfecting step “shall be followed by wiping with a residue-free disinfecting agent such as Sterile 70% IPA, which is allowed to dry before compounding begins.”

Always follow site protocols and SOPs

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