FL-60 Shift Hand-off & Cleaning Assessment - duplicate

Information

Shift Hand-Off / Assessment Title (i.e. Fluid Bed # 473/ Nifedipine ER/ 10/01/16)
Fluid Bed #:
Product Name:
Lot #:
NDC # (Last Four(4) Digits):
Clean Type:
Conducted on
Prepared by

Shift Handoff

Department Shift Hand-Off

This Department Shift Handoff was developed to help improve the collaboration between shfts of the Fluid Bed Teams

Cleaning sheets are up to date? If there is a no response... give explanation of why.j

FL-60 Process Steps

FL 60 Water Soluble Clean - Water First Type Clean
Increments of 1 Hour
FL 60 Water Soluble Clean - Water First Type Clean
Increments of 1 Hour
FL 60 ER Clean - Water First Type Clean
Increments of 1 Hour
FL 60 ER Clean - BH First Type Clean
Increments of 1 Hour
Step 1. Log out books and room. Complete TBC tag and insert in door
Step 2. Remove all trash and evidence of previous batch
Step 3. Obtain all applicable cleaning sheets from supervisor. Determine type of clean (A or B).
Step 4. Retrieve skid and chamber lift for chamber lowering
Step 5. Deflate bag seal
Step 6. Remove fluid bed insert and set off to the side in production room
Step 7. Put chamber lift in place in order to lower chamber lift
Step 8. Use ladder from back room or mobile ladder within room and loosen the expansion chamber bolts
Step 9. Lower the expansion chamber with chamber lift and place on skid covered with polyliners
Step 10. Lower bags or D-screens
Step 11. "If filter bags were being utilized, remove d-ring and then unclip from bag carriage and place in poly-liner. Fill out TBC tag with fluid bed type and product information. and put in poly-liner with filter bags. Also place the completed filter bag log inside outer poly-liner. Set off to the side of production room. Ensure that bag sock clips remain on bag carriage. NOTE: Remember to also place gral sock in poly-liner with bags if applicable"
Step 12. "Remove insert, chamber, and any additional equipment to be cleaned in washroom. NOTE: Electrical equipment such as table top scales, mixers and pumps to remain in room at this time. "
Step 13. Take filter bags to NEX 420B. Return chamber lift and retrieve treestand.
Step 14. Contact supervisor to have maintenance check exhaust valves, remove chopper/impeller blades (if applicable) and disassemble insert (rotor/wurster) in washroom
Step 15. Place treestand under upper chamber of fluid bed
Step 16. Remove upper chamber gasket and bag seals
Step 17. Vacuum excess powder in upper chamber, track of bag seal, and plenum. Also sweep excess powder from under and around the bottom of the fluid bed.
Step 18. "Disassemble inlet valve, inlet temp. probe, drain plug on plenum, and the solution pump. NOTE: Clean and bag elements when applicable."
Step 19. Disassemble gral sight glasses, caps, and gral sock holder from top of gral.
Step 20. "Swing open plunger valve while gral is raised Extend plunger using compressed air."
Step 21. Disassemble plunger assembly
Step 22. Remove any and all plugs and caps from gral bowl. Also remove the seal from the top lip of gral bowl
Step 23. Disassemble Nilfisk vacuum and place waste in poly-liner
Step 24. Sign up Cleaning Checklist
Step 25. "Lock out fluid bed (contact coordinator if not qualified to perform this task). NOTE: Affected operators to place their own locks on group lock box"
Step 26. "Retrieve cleaning cage, boots, and pump sprayer if applicable. NOTE: While retrieving cleaning cage and boots, dispose of vacuum waste."
Step 27. Clean small electrical equipment (table top scales, mixers, vacuum head and pumps) with alcohol and purified water. Bag/tag and place equipment with book on skid outside the room.
Step 28. Wipe down outlet covers, scale displays, control panels, and computer terminal with alcohol and purified water in preparation for tape.
Step 29. Wipe down tools from shadow board with alcohol and purified water, put in poly-liner, and place in back closet. Remove shadow board from wall, wipe down with alcohol and purified water, and place in back closet.
Step 30. Prepare coverings and mask off outlets, scale displays, control panels, and computer terminal with prepared coverings.
Step 31. "TYPE A CLEAN: Apply 100% Bh to all contact parts, to the out fluid bed and gral, as well as the entire production room (walls, ceiling, and floor). NOTE: Soaking is required for 30 - 60 minutes. Do not allow Bh to dry on surfaces. TYPE B CLEAN: Complete initial rinse of the room.
Step 32. TYPE A CLEAN: Rinse Bh from all soaking parts, equipment, walls, floor, and ceiling.
Step 33. Both Types - Apply 100% BH-38 with pump sprayer to ceiling of production room using pump sprayer. Rinse.
Step 34. "Apply 100% BH with pump sprayer and scrub inside and outside of entire fluid bed (upper chamber, plenum, leg structures, pump and inlet area) as well as the rear wall behind fluid bed. Areas of focus: Underneath plenum, inlet duct work, bag seal track, exhaust valve areas, bag cylinders, pulleys, cables, and outer lip of upper chamber"
Step 35. Rinse entire fluid bed and the rear wall behind fluid bed. NOTE: When cleaning production room walls ensure that any d-screens, seals, bag carriages, and gaskets hanging on the walls are also cleaned. Also computer cabinet should be cleaned along with the most convenient wall.
Step 36. Apply 100% BH with pump sprayer and scrub left wall of production room. Rinse.
Step 37. Apply 100% BH with pump sprayer and scrub right wall of production room. Rinse.
Step 38. Apply 100% BH with pump sprayer and scrub front wall of production room. Rinse.
Step 39. Clean small parts: Inlet seal assembly, plenum parts, bag seals, upper chamber gasket(s), gral parts, chairs, and tables.
Step 40. Apply 100% BH to floor scales and scrub. Utilize scrapper for solution build up around scales if necessary.
Step 41. Perform final rinse of production room (ceiling, walls, and floor)
Step 42. Raise scale and hose out scale pit
Step 43. Purify water rinse all contact parts. Log the purified water info in the log books and on cleaning sheet.
Step 44. Perform the santization of the floor drain. Record this in the production room log book
Step 45. Contact supervisor and perform pre-dry check
Step 46. Retrieve heater fan and call AQL
Step 47. "Dry production room: Pull tape and coverings from outlets, displays, control panels, and computer terminals NOTE: Hand dry using teri-towels. Special attention to flat surfaces, ledges, channels, and small parts. "
Step 48. Mop floor and scale pit
Step 49. Clean windows and door jam

Supervisor Assessment

1. Check lights, ceiling, walls, floor, doors and windows for powder or residue.
2. Check support beam and bag Pistons
3. Check Plenum and Expansion Chamber - Inlet Valve
Step 3
4. Check under plenum.
Step 4 -
5. Check Bed Framing and Attachments
Step 5 -
6. Check Gral Bowl and Assembly.
Step 6
7. Check for moisture in inner closet
8. Room is completely dry and ready for Quality Check.
9. Room is ready for Quality Check. IF FAIL, what rework is necessary?