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09 Cleaning of Capsule Filling Area 09

This standard operating procedure outlines the cleaning process for a capsule filling area between product changes. It details cleaning the filling machine, inspection machine, walls, floors, air handling unit filter, and other areas. The responsibilities of cleaners, production chemist, and production in-charge are defined. Records of cleaning are to be entered in the batch manufacturing record. The cleaning process is conducted during product changeovers.

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Ravi Yadav
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242 views2 pages

09 Cleaning of Capsule Filling Area 09

This standard operating procedure outlines the cleaning process for a capsule filling area between product changes. It details cleaning the filling machine, inspection machine, walls, floors, air handling unit filter, and other areas. The responsibilities of cleaners, production chemist, and production in-charge are defined. Records of cleaning are to be entered in the batch manufacturing record. The cleaning process is conducted during product changeovers.

Uploaded by

Ravi Yadav
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-09
PROCEDURE FOR CLEANING OF Revision No 001
Title
CAPSULE FILLING AREA Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-09
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide a procedure for cleaning of capsule filling area.

2. .SCOPE :
Covers the cleaning of capsule filling area in capsule department for product change over.

3. RESPONSIBILITY
Cleaners, Production Chemist, Production In-charge.

4. PROCEDURE
4.1 After the completion of a batch, area is made clean for the commencement of next batch.
4.2 Remove all the previous product label.
4.3 Clean the semi automatic capsule filling machine as per S.O.P. No QN/CAP/CL-03
4.4 Clean the inspection cum polishing machine as per the S.O.P. No QN/CAP/CL-04
4.5 Clean thoroughly the walls, floor with soap solution and water respectively.
4.6 Clean the A.H.U. Filter.
4.7 De-dust the dirt collected on the light fixtures and on the A. C.
4.8 Walls & floor joints to be cleaned at the time of product change over.
4.9 After cleaning, put the status label on each equipment and on the door.

5. PRECAUTION

5.1 Stop the activity and inform the Q.A In-charge incase of any unusual observation.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
QUALITY NEXGEN PHARMACEUTICAL
Page 2 of 2
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/CL-09
PROCEDURE FOR CLEANING OF Revision No 001
Title
CAPSULE FILLING AREA Issue Date 01.03.2016
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/CL-09
Distribution Supersedes
PRODUCTION

6. RECORDS / SPECIMEN

6.1 Carry out the cleaning procedure as per above and enter in to the B.M.R.

7. FREQUENCY

At the time of product change over.

8. REVISION HISTORY
8.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change


QN/CAP/CL-09 01.04.2016 QN/CAP/CL-09 1] Change in Format.
2] Added History,
Precaution, Frequency,
Records and Revision
History table in SOP.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER

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