Cleaning of capsule inspection cum polishing machine
PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER
1. Dedusting external surfaces Using cleaned nylon brush and vacuum cleaner. Remove the filter
bag of the vacuum can placed below the machine.
2. Dismantling-Remove:
a. Hopper assembly with sieves and trays.
b. Conveyor belt with guides and slitter guards.
c.Polishing chamber with brush and polishing cloth.
d. Capsule ejection chute.
e.Capsule transfer chute.
f. Vacuum hose pipe.
3. Cleaning of parts
Clean the above parts except polishing brush and cloth by washing with 0.1%
Teepol solution scrubbing with soft clean nylon brush. Rinse with a jet of potable water followed
by rinsing with 5 micron filtered water.
4 Cleaning of polishing brush and polishing cloth – The polishing brush and polishing cloth
is soaked in hot water for 10-15 minutes.
a. The bristles of polishing brush are cleaned using 0.1% Teepol solution. The polishing cloth is
washed with 0.1% Teepol solution and scrubbing with soft clean nylon brush. Rinse the polishing
brush and cloth with a jet of potable water followed by rinsing with micron filtered water.
5. Cleaning of machine body Clean with 0.1% Teepol solution and scrubbing with soft
nylon brush clean with potable water.
6. Verification of cleaning effectiveness – The Purified water cleaning in the product hopper is sent
to the quality control department to ensure that no previous product is present
7. Drying The cleaned dried parts of step 3 are wiped using a clean lint free duster. The polishing brush
and polishing cloth are air dried in SS trolley and then kept in tray dryer for one hour at 50-60 °C.
8. Assembling – Reassemble all the parts of the machine carefully checking for the correctness
of assembling. Replace the filter bag in the vacuum cleaner can under the machine with a clean filter bag.
Note:
1. Step 6 is a validation exercise for every six months and at product changeover.
2. Fix the ‘cleaned tag with date and Signature.
3. Replace vacuum filter bag from vacuum can below the machine every day at start of polishing.
4. Dry clean the machine with clean lint free duster, if it is not used with 24 hours.
B. PROCEDURE FOR BATCH TO BATCH CHANGEOVER
1. Remove powder from the powder collection trays.
2 Dedust external surfaces of machine with vacuum cleaner.
3. Dry clean the sieves placed in hopper.
4. Dedust the conveyor belt with vacuum cleaner.
5. Open the polishing chamber and de-dust the polishing brush with vacuum cleaner.
6.Separate the polishing cloth from polishing chamber and replace it with a fresh polishing cloths
C PROCEDURE TO BE FOLLOWED FOR CLEANING AT THE END OF SHIFT
1. Remove filled capsules from hopper.
2 Remove the powder from powder collection trays.
3. Dedust external surface with vacuum cleaner and clean with clean lint free duster.
4. Clean and dry conveyor belt with vacuum cleaner.
5, Open the polishing chamber and de-dust the polishing brush and polishing cloth with vacuum cleaner and refit it.
6. Cover the machine with suitable cloth cover.
7. If machine is kept for more than 2 days without operation follow procedure B.
Caution Switch off electrical mains of the machine.
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
Cleaning of capsule inspection cum polishing machine
