FL-60 Area Lead Full Clean Final Check

Information

Area Lead Full Clean Final Check 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

Supervisor Assessment

Are all cleaning sheets up to date?
1. Check lights, ceiling, walls, floor, doors and windows for powder or residue.
Door jams and on the floor around sliding or swinging doors.
Floor under computer cabinet.
Special attention to floor under plenum and the back wall behind fluid bed.
Do any of the above items require further attention? If so document with comments and photos.
2. Check inside upper chamber of fluid bed.
Exhaust valves. Are they free of beads, pellets, or powder?
Bag shake pistons and attached cables
Bag seal track, ledges, and the bag seals themselves. Inspect the entire length of each bag seal.
Inspect cross bar for product build up.
Do any of the above items require further attention? If so document with comments and photos.
3. Upper Fluid Bed Exterior
Exterior lip/ledge at bottom of upper chamber
Upper chamber seal track
Do any of the above items require further attention? If so document with comments and photos.
4. Check Plenum and Inlet Area
Inspect interior bowl area of plenum, including drain hole, rotor coupler (threaded holes), and inlet air entry area.
Using a flash light inspect the inlet duct work as far as visually possible as well as the inlet air seal area.
Examine the exterior of the plenum bowl, particularly underneath the bowl and the support beams.
Step 4 -
Do any of the above items require further attention? If so document with comments and photos.
5. Check Bed Framing and Attachments
Vertical Support Beams
On top of winch housings.
Product temperature probe storage tube.
Pump area including the pump caps.
Nooks and crannies in the area of the air pressure gauges.
Hoses, tubing, and cords that are present on the fluid bed.
Do any of the above items require further attention? Is so document with comments and photos.
6. Check Gral Bowl and Associated Assemblies
Inspect the bowl interior including any drain holes.
Inspect the interior ceiling of the gral particularly where the impeller and chopper blades attach.
Inspect impeller and chopper bladdes
Using a ladder if necessary, inspect the very top of the gral house for product build up.
Inspect all ports for the sight glasses, gral socks, and probes that exist on the top of the gral.
Inspect the discharge valve assembly. Pay close attention to areas around shafts, areas underneath the valve area that are out of sight and around any ledges or protrusions.
Inspect underneath the gral bowl and it's supporting arms.
Do any of the above items require further attention? If so document with comments and photos.
7. Check for moisture in inner closet
8. Is room dry enough for AQL inspection?
9. Room is ready for Quality Check. IF FAIL, what rework is necessary?
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