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
Temperature
RH%
Differential pressure
2. Daily cleaning record
Ceiling & walls.
Diffusers / pendent.
View panel of doors & window.
SS, ALU pallet; SS stand; HDPE container & pallet.
Table tools, granite trolleys, sample box.
Electrical panel /waste bin.
Floor & coving.
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
Hopper
Butterfly valve & triclovar clamp
Force feeder / Gravity feeder
Inlet connector
Turret
Powder scrapper
Acrylic guard
Shaft
B. Critical parts check list for deburring / de-duster machine
SS Bowl
Outlet chute
Rejection tray
C. Critical parts check list for metal detector
Inlet chute
 Outlet chute
Rejection tray /container
D. Critical parts check list for die & punch assembling
Ensuring assembling of dies is properly locked by die-locked.
Ensuring assembling of punches every lower punch is properly locked by break-plug.

Operational instruction:
Ensure the operator wears hand gloves, nose mask & other safety gowning as per product
MSDS required.
Ensure the equipment to be used is certified with clean level.
Replace the cleaned level with equipment level; affix the clean level with the BMR.

Storage and Cleaning Procedure of Dies & Punches

Tooling Storage:

Store Tooling in Dies & Punches room in designated racks with tooling storage rack label
after applying a thin smear of lubricant oil over the punch and die surface.

Fill out a new Tooling Storage Rack Label for new set with the following information:

a) Rack number

b) Set Number

c) Product name & Strength

d) Punch dimensions

e) Punch specification

f) Tooling D/B/BB

g) Quantity

h) Embossing on Upper punch

i) Embossing on Lower punch

j) Checked by

NOTE: For plain tooling, meaning there is no embossing on the face of the tooling, the
word “plain” shall be noted.

Once all verifications are complete, attach the tooling set inspection report together and
file in the production office.

The tooling reference should be updated by the production executive for locating the
punch set giving following details:-

1. Product Name,

2. Rack Number &

3. Set Number

Cleaning of tooling:

A) For New Punches and Dies-

1. Remove the layer of grease (if any) and immerse all new punches and dies into 70% v/v
IPA for about 20 minutes and clean with the help of dry lint free cloth.

2. Wipe & clean the die bore by inserting clean dry lint free cloth into it.
3. After cleaning, discard the used 70% v/v IPA by draining it into the drain. Clean the
container of IPA to ensure the absence of any particulate matter.

4. Ensure the cleanliness of dies visually.

5. Check punches visually for cleanliness and absence of particulate matter.

6. Repeat step No. 1 to 5 by using fresh 70% v/v IPA if required.

7. Clean dies and punches by using clean dry lint free cloth to remove IPA (If present).

8. Apply a thin layer of food grade lubricant oil/liquid paraffin manually on the surface of
punches and dies including the inner surface of die bores.

B) For Used Punches and Dies-

Before Fixing to the Machine:-

1. Clean punches and dies with the help of clean dry lint free cloth.

2. Wipe the Punches and dies thoroughly with 70% v/v IPA. Dry with clean dry lint free
cloth.
3. Check visually the cleanliness of individual punch and die for the absence of traces of
70% v/v IPA and any extraneous material.

After Removing From the Machine:-

1. Clean punches and dies with the help of clean dry lint free cloth.

2. Immerse all punches and dies in 70% v/v IPA solution for minimum 20 min and clean
using a clean lint free cloth.

3. Wipe all punches, dies and die-bores thoroughly with a clean dry lint free cloth.

4. Check the punches and dies for the absence of previous material and repeat steps 2 to 4
if required.

5. Apply a thin layer of food grade lubricant oil/liquid paraffin manually on the surface of
punches and dies including the inner surface of die bores.