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Facility - Environment and Maintenance SOPs

SOP's listed as links are currently available. Others will be coming soon.
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Number Title
4.0 Environmental Particulates
4.0.1 Building Maintenance
4.001 Air Temperature and Humidity Monitoring
4.001.01 Environmental monitoring of the buffer or clean area: Humidity
4.001.1 Thermometer Calibration, Electronic
4.001.2 Thermometer Calibration, Glass or Metal.doc
4.001.3 Hygrometer Calibration
4.002 Refrigerator Temperature Monitoring
4.003 Freezer Temperature Monitoring
4.004 Incubator Temperature Monitoring
4.005 Air Return / Pre-filter Changing
4.005.1 Changing Prefilters in the Cleanroom Area
4.006 HEPA Filter Changing
4.007 Clean Room Certification
4.007 u Clean Room Certification (USP 2019)
4.008 Laminar Flow Hood Certification
4.009 Plumbed Eyewash Inspection
4.01 Emergency Shower Inspection
4.011 Disposal of Hazardous Waste
4.012 Foot Bath
4.015 Positive Pressure Monitoring
4.015.01 Cleanroom Positive Pressure Monitoring
4.015.02 Anteroom Positive Pressure Monitoring
4.016 Air Filter Changing
4.017 Pharmacy Temperature
4.017.1 HVAC Failure
4.018 Outsourced environmental monitoring of laminar air-flow workbench, barrier isolator, buffer or clean area and anteroom area Microbial organisms
4.019 Cleaning and Sanitization of Equipment for Compounding Ointments
4.020 Determining Pressure Drop Across a HEPA Filter
4.021 Determining Differential Pressure Between Aseptic and Non-Aseptic Areas
4.022 Sterility Compounding Facility and Risk Levels
4.03 Powder Hood Use and Maintenance
4.040 Pressure Monitoring HD Sterile Compounding Areas
4.041 Pressure Monitoring HD Non-Sterile Compounding Areas
4.042 Pressure Monitoring HD Storage Areas
4.05 u Microbiological Air and Surface Monitoring, General (USP 2019)
4.06 u Monitoring Air Quality for Viable Airborne Particles (USP 2019)
4.07 u Monitoring - Surface Sampling (USP 2019)