- SOP for washing and inspection of garments.
- Objective:
- To lay down a procedure for washing and inspection of garments.
- Scope:
- This SOP is applicable for washing and inspection of garments for dry powder Injection facility in formulation.
- Responsibility:
- Production operator / technician – responsible for washing and inspection of garments
- Production officer / Executive – to ensure that washing and inspection of garments are carried out as per SOP.
- Accountability:
- Production Head and QA head shall be accountable for the compliance of SOP.
- Abbreviations:
- SOP : Standard Operating Procedure.
- Procedure:
- Pre-start-up:
- Visually check the cleanliness of garment wash room.
- Check the status of the machine for its operation.
- Clean the Garment washing machine before carrying out the washing of garments as per SOP.
- Wash the controlled area and critical area garments separately.
- Wash the booties of garments separately.
- Visually check that there are no cloths inside the machine of previous cycle
- Start-up:
- Operation of the Garment washing:
- Insert the plug in switch board.
- Press the ON /OFF button.
- After pressing of ON/OFF button machine is ready load the garment.
- Press the door open button.
- The door open led will be on and the door is ready to open.
- Open the door.
- Place the garments uniformly into the machine according to the recommended load capacity.
- Place the little clothing materials inside the pillow cases to avoid them slip into the pump and filter.
- Make sure that there is no clothing at the side of the door.
- Close the front door by pushing it lightly. If the door does not close completely, the machine could not be started.
- Front door is locked until washing cycle is complete and it will take two minutes to open after completion of washing cycle.
- Front door can be opened only when the machine is off.
- Open the tap and use purified water filtered through 1 micron filter for washing of garments.
- Place the machine drain hose pipe in main drain of garment washing room.
- Fill the detergent in the respective compartment provided on the top of machine.
- Close the detergent dispenser box.
- Select the program according to dirt strength.
- When the desired program is selected, related spin speed can be adjusted for garments washing and drying according to requirement
- Push the start button to operate the machine.
- Take the washing cycle according selected program.
- Machine stops automatically when the entire program is finished.
- Turn off the tap.
- In one or two minutes when the door open led lights up ,press the door open button and open the door.
- Press the on/off button to switch off the machine.
- Unload the machine and leave the front door open.
- Check the door hood for any traces of water; if water left in the door hood remove it by soft cotton.
- Place the washed and dried garments on the S.S. perforated table under Laminar Air Flow Unit.
- Shut Down:
- after completion of the operation Switch “OFF” the machine.
- Switch “OFF” the main Electric supply.
- Clean the machine as per SOP and get cleaning checked by production officer.
- Record the operation, cleaning & maintenance details in the equipment log book as per SOP and get checked by production officer.
- Inspection of Garments:
- Firstly check the garments visually for cleanliness that is any stains.
- If the garments are not found visually clean repeat the cleaning procedure.
- The washing area supervisor/officer should check the washed garments for following defects like defective Zip, unclean garments, torn clothing, torn velcroes or any fiber shedding ends.
- Reject the defective garments. The washing area supervisor/officer to take the decision for re-washing/ repair/ disposal of the rejected garments based on the defect.
- Incase of torn velcroes, defective zip and miner tear of the garments, send the garments for repair duly covered in a poly bag and record of the same to be maintained in the prescribed format.
- Iron the inspected garments under table mounted Laminar Air Flow Unit.
- Pack each set of garment with booties in lint free garment bags under LAF for sterilization.
- The washing area supervisor / officer to maintain the record of the controlled/critical area garments as per the specimen format attached.
- Forms and Records (Annexures)
- Garments washing and inspection record (controlled area) – Annexure -1
- Garments washing and inspection record (Aseptic area)- Annexure – 2
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, Stores,
- History
Date Revision Number Reason for Revision
– 00 New SOP
Annexure -1
Garments washing and inspection record (controlled area)
| Washing of Garments | Inspection of Garments | |||||||
| Description of Garments | Quantity Given for Washing | Washed By | No. of Garments Found OK | No. of Garments Rejected | Inspected By | Remarks | ||
| Inner Garment Set | ||||||||
| Secondary Garment Set | ||||||||
Inner Garment set consists of one head cover, one shirt, one trouser and one pair of Booty.
- Secondary garment set consists of one headgear, boiler suit and one pair of booty.
Garments Washing and Inspection Record (Controlled Area)
| Washing of Garments | Inspection of Garments | |||||||
| Description of Garments | Quantity Given for Washing | Washed By | No. of Garments Found OK | No. of Garments Rejected | Inspected By | Remarks | ||
| Controlled Area Garments | ||||||||
| Nose Mask | ||||||||
| Lint Free Wipe | ||||||||
- Inner Garment set consists of one head cover, one shirt, one trouser and one pair of Booty.
- Secondary garment set consists of one headgear, boiler suit and one pair of booty.
Annexure – 2
Garments washing and inspection record (Aseptic area)
| Washing of Garments | Inspection of Garments | |||||||
| Description of Garments | Quantity Given for Washing | Washed By | No. of Garments Found OK | No. of Garments Rejected | Inspected By | Remarks | ||
| Inner Garment Set | ||||||||
| Secondary Garment Set | ||||||||
Note:
- Inner Garment set consists of one head cover, one shirt, one trouser and one pair of Booty.
- Secondary garment set consists of one headgear, boiler suit and one pair of booty.
Garments Washing and Inspection Record (Controlled Area)
| Washing of Garments | Inspection of Garments | |||||||
| Description of Garments | Quantity Given for Washing | Washed By | No. of Garments Found OK | No. of Garments Rejected | Inspected By | Remarks | ||
| Controlled Area Garments | ||||||||
| Nose Mask | ||||||||
| Lint Free Wipe | ||||||||
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