Manufacturing Safety Culture Walkthrough

• Conducted on

  Date

• Prepared by

• Location

  Select 321 (Pre-Culture) 324 (Bioreactor) 327 (Downstream) 314 (Downstream) 317 (Bioreactor) 335 (Viral Room) 356 (Fill) 352 (Buffer) 342 (Buffer Storage) 343 (Cold Storage) Grade D 344 (VI) 300 (Gowning) Airlocks 331 (Waste)

  • 321 (Pre-Culture)
  • 324 (Bioreactor)
  • 327 (Downstream)
  • 314 (Downstream)
  • 317 (Bioreactor)
  • 335 (Viral Room)
  • 356 (Fill)
  • 352 (Buffer)
  • 342 (Buffer Storage)
  • 343 (Cold Storage)
  • Grade D
  • 344 (VI)
  • 300 (Gowning)
  • Airlocks
  • 331 (Waste)

• Is there clear room signage present (i.e. room number, maximum occupancy, exit signs)?

  Yes

  No

  N/A

• Is the emergency contact information visible and nearby?

  Yes

  No

  N/A

• Are evacuation routes clearly posted?

  Yes

  No

  N/A

• Are fire extinguishers available and mounted with no visible signs of rouging or damage?

  Yes

  No

  N/A

• Is PPE available where needed?

  Yes

  No

  N/A

• If spill kit is present in the room, is the kit stocked with all necessary material?

  Yes

  No

  N/A

• If eyewash and shower is present, is it easily accessible and free of obstruction?

  Yes

  No

  N/A

• Are SporKlenz and IPA bottles present in the room and at the entrance to the passthroughs?

  Yes

  No

  N/A

• Are all HVAC returns clearly marked and not obstructed?

  Yes

  No

  N/A

• If there a WFI/ PW port present in the room, are the valves clearly labeled with no visible leaking?

  Yes

  No

  N/A

• If there is a BSC in the room, is the sash at the indicated height?

  Yes

  No

  N/A

Trash/Debris

• Are sharps containers present and closed (if not actively in use)?

  Yes

  No

  N/A

• Is the floor clear of debris, and workspace free of clutter?

  Yes

  No

  N/A

• Is the trash appropriately disposed of?

  Yes

  No

  N/A

• Is hazardous waste disposed of properly in biohazardous waste bins?

  Yes

  No

  N/A

• Is the drain free of debris?

  Yes

  No

  N/A

Electrical

• Is there WiFi signal in all areas of the room?

  Yes

  No

  N/A

• Are all electrical plugs in good working condition?

  Yes

  No

  N/A

• Are extension cords not daisy chained, and do not pose a tripping hazard?

  Yes

  No

  N/A

• Are there any burnt out lights?

  Yes

  No

  N/A

Ingress/Egress

• Are all doors able to open and close fully?

  Yes

  No

  N/A

• Are all passthrough functioning properly and in good condition?

  Yes

  No

  N/A

• Are there sharp edges on passthroughs or doors?

  Yes

  No

  N/A

Storage

• Are shelving units in good condition with no signs of damage or rouging?

  Yes

  No

  N/A

• Are all containers (buffer, chemicals, etc.) in good condition and closed?

  Yes

  No

  N/A

• Are all scissors closed and stored?

  Select Yes No N/A

  • Yes
  • No
  • N/A

• Are buffers and chemicals appropriately stored?

  Yes

  No

  N/A

• Are stored items at least 18" away from the ceiling?

  Yes

  No

  N/A