procedure for cleaning of Multimill
1.0 OBJECTIVE :
To lay down a procedure for cleaning of Multimill
2.0 SCOPE :
This SOP is applicable to the cleaning of Multimill (Bectochem) in granulation area
3.0 RESPONSIBILITY:
Production: Technical Associate/Officer /Executive/Assistant Manager Head Production: To ensure execution & compliance
Head QA: To ensure the compliance
4.0 PROCEDURE:
4.1 CLEANING : TYPE A
Change over from one batch to next batch of the same product, same potency
and of similar product with ascending potency.
4.1.1 Remove “ TO BE CLEANED “ label and affix “ UNDER CLEANING “ label to
the machine with date and signature of production officer.
4.1.2 Enter the cleaning starting time in equipment sequential log book as per SOP.
4.1.3 Ensure that the main power supply is switched OFF.
4.1.4 Remove the adhered material on the Multimill by using vacuum cleaner.
4.1.5 Dismantle the discharge hopper, base plate, screen, beater assembly and the
gaskets.
4.1.6 Clean the feeding port, beater assembly, discharge hopper, base plate,
screen and gaskets with lint free cloth.
4.1.7 Replace the ‘UNDER CLEANING’ status label with “CLEANED” status label with
date and signature of the Production Officer.
4.1.8 Record the cleaning activity in equipment sequential log book as per
SOP No.:
4.2 TYPE B:
This is a cleaning procedure for Change over of product with different actives /
color / descending potency or after maintenance of contact parts.
4.2.1 Follow the procedure from step 4.1.1 to 4.1.5.
4.2.2 Transfer the above all parts in respective cleaning area.
4.2.3 Clean the dismantled parts of the Multi mill using approx. 60.0 to 80.0kg purified
water. Scrub all dismantled parts with nylon scrubber.
4.2.4 Wash all the parts using approx. 30.0 to 50.0 kg purified water.
4.2.5 Rinse all parts with approx. 20.0 to 30.0 kg purified water.
4.2.6 Clean the screen by using approx. 20.0 to 30.0 kg purified water and scrub it with
nylon scrubber.
4.2.7 Wash the screen using approx. 10.0 to 20.0 kg purified water.
4.2.8 Rinse the screen by applying approx. 10.0 to 20.0 kg purified water so as to ensure
the complete removal of the previous product.
4.2.9 Dry the screen by using compressed air followed by clean dry lint free cloth.
4.2.10 Wipe the body of the Multimill with wet duster soaked in purified water.
4.2.11 Dry the dismantled parts with compressed air followed by dry lint free duster.
4.2.12 Wipe all dismantled parts of the Multimill and its body with 70% v/v IPA solution.
4.2.13 Assemble the Multimill without screen. Store the screen by covering with a polythene bag and label as ‘CLEANED’ status label with date and signature of the
production officer.
4.2.14 Transfer the screen to the screen storage area.
4.2.15 Affix label on Multimill as “CLEANED” with date and signature of the Production
Officer.
4.2.16 Record the cleaning time in equipment sequential log book as per SOP.
5.0 ANNEXURE (S) :
Nil
6.0 REFERENCE (S):
SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP).
SOP: Procedure for area line clearance. SOP: Status Labeling in Production Dept.
SOP: Procedure for Inventory, cleaning and storage of sieves and screens.
7.0 ABBREVIATION
SOP: Standard Operating Procedure
BMR : Batch Manufacturing Record
IPA : Iso Propyl Alcohol
REVISION CARD
| SR.
NO. |
REVISION NO. | REVISION DATE | DETAILS OF REVISION | REASON (S)FOR REVISION | REFERENCE CHANGE CONTROL
NO. |
| 1 | 00 | — | — | New SOP | — |
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt