Line clearance before compression ׀ Area & equipment clearance before compression
Line Clearance
Line clearance defined as the segregation and
cleaning of different processing and work areas to avoid cross-contamination.
Line clearance during compression
Line clearance divided into two major categories:
A. Area
clearance
B. Equipment
clearance
Area clearance
1. Environmental
monitoring record
ü Temperature
ü RH%
ü Differential
pressure
2. Daily
cleaning record
ü Ceiling
& walls.
ü Diffusers
/ pendent.
ü View
panel of doors & window.
ü SS,
ALU pallet; SS stand; HDPE container & pallet.
ü Table
tools, granite trolleys, sample box.
ü Electrical
panel /waste bin.
ü Floor
& coving.
ü Disinfectant
used in wall & floor.
Equipment clearance
1. Wash
water cum report
2. Daily
balance performance check. ( Once daily)
3. Performance
check of metal detector.
4. Line
clearance record of equipment. (individual equipment utilization log book)
5. Cleaning
record of compression machine. (to inspect an authorized check list for
Equipment cleaning record)
6. Critical
parts check list :-
A. Critical
parts check list for compression machine
ü Hopper
ü Turret
ü Shaft
B. Critical
parts check list for deburring / de-duster machine
ü SS
Bowl
ü Outlet
chute
ü Rejection
tray
C. Critical
parts check list for metal detector
ü Inlet
chute
ü Outlet
chute
ü Rejection
tray /container
D. Critical
parts check list for die & punch assembling
ü Ensuring
assembling of dies is properly locked by die-locked.
ü Ensuring
assembling of punches every lower punch is properly locked by break-plug.
Operational instruction:
ü Ensure
the operator wears hand gloves, nose mask & other safety gowning as per
product MSDS required.
ü Ensure
the equipment to be used is certified with clean level.
ü Replace
the cleaned level with equipment level; affix the clean level with the BMR.