Procedure for Cleaning of Bottle Machine

1. OBJECTIVE
To lay down the procedure for Cleaning of Bottle Machine

2. SCOPE
This procedure is applicable to Production, Liquid Filling section

3. RESPONSIBILITY
• QA Officer
• Production Pharmacist/ Above

4. SAFETY INSTRUCTIONS
• In case of any unusual observation, stop the activity and inform the Q.A. Department

5. PROCEDURE
5.1 Run the machine empty till the product is completely poured out.
5.2 Circulate Purified water for 10 Minutes.
5.3 Run the machine empty till all the water in the tubes is completely poured out.
5.4 Dismantle all the parts in a reverse manner.
5.5 Wash the parts with soap solution & wash with water to remove traces of soap solution
5.6 Keep all the washed parts in the S.S. container & cover with the lid.
5.7 When needed for filling take out the syringe, connect it to the machine, and run Purified water through it for 10 minutes.
5.8 Run the machine empty till all the water in the tube is completely poured out.

6. RELATED DOCUMENTS
N/A

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Production Department 01 ,

8. ABBREVIATIONS
QA Quality Assurance
SS StainlessSteel

9. REVISION HISTORY

Revision No. Issue Date Supersedes Reason of Change / Description
          Revision No.              Dated     
00 06/09/2022 00                            N/A First Version

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Pharmaceutical Services

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