SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Leak test of unit packs
Title: Entry/Exit Procedure for Manufacturing Area
Prepared By
Concerned Dept
Checked By
Concerned Dept
Prepared By Objective
Checked By
1.
Concerned Dept
Concerned Dept
SOP. No.
:
SPL/ SOP/PR/018
Page No.
:
1 of 2
Supersedes
SOP. No.
:
New
HLM/ SOP/MF/001
Revision
Page No. No.
:
00
1 of 5
Reviewed By
QA
Approved By
QA-Head
Effective Date :
Supersedes
Review Date
New
Revision No.
00
Reviewed By
QA
Approved By
QA-Head
Effective Date
:
Review Date
To define the procedure for Leak test of unit packs.
2.
Scope
This procedure is applicable to all Products of Solitaire Pharmacia Pvt. Ltd., Baddi.
3.
Responsibility
Production supervisor: Implementation of SOP & documentation.
4.
Accountability
Head- Production
5.
5.1
Procedure
For Strip & Blisters: Start & every two hours.
5.1.1
Fill the leak test apparatus up to its half capacity (As marked) with water and add 50 to 60 ml. of 1
% w/v aqueous solution of sodium lauryl sulfate & 10 to 12 ml. of 10 % w/v Methylene blue
solution in to it (for 2 liter water).
5.1.2
Collect sealed blisters/ strips directly from the machine ensuring representation of all pockets of
strip / blister sealing rollers.
5.1.3
Put the samples along with some weight in to the leak test apparatus and ensure complete
submerging of blister / strips in to water.
5.1.4
Cover the leak test apparatus with lid; connect rubber tubing of vacuum line with leak test
apparatus.
5.1.5
Adjust the vacuum valve and run the vacuum minimum till the vacuum gauge indicates 380 mm /
15 inch mercury and maintain the vacuum for 2 minutes.
5.1.6
Detach the rubber tube from leak test apparatus; keep it for minimum one minute.
5.1.7
Remove the lid and take out blisters/ strips. Wipe dry with clean dry cotton cloth.
5.1.8
Cut, open the blisters / strips and examine tablets/ capsules inside carefully.
5.1.9
All pockets should pass leak test. In case of any failure stop the machine and adjust pressure /
temperature of sealing roller.
Format No.SPL/QA/001
SOLITAIRE PHARMACIA PVT. LTD.
RESTRICTED CIRCULATION
AUTHORISED PERSONS ONLY
STANDARD OPERATING PROCEDURE
Title: Leak test of unit packs
Title: Entry/Exit Procedure for Manufacturing Area
Prepared By
Concerned Dept
Checked By
Concerned Dept
Reviewed By
QA
Approved By
QA-Head
SOP. No.
:
SPL/ SOP/PR/018
Page No.
:
2 of 2
Supersedes
SOP. No.
:
New
HLM/ SOP/MF/001
Revision
Page No. No.
:
00
2 of 5
Effective Date :
Supersedes
Review Date
New
Revision No.
00
:
5.1.10
leak By
test in startReviewed
& everyBytwo hours.Approved
RecordBy
observations
in batch
record.
Prepared By Conduct
Checked
Effective
Date packingReview
Date
Concerned Dept
6.
Concerned Dept
QA
QA-Head
Records/Formats:
NA
7.
Annexure:
NA
8.
Reference:
Nil
9.
10.
Abbreviations:
SPL
-
Solitaire Pharmacia Pvt. Ltd., Baddi.
SOP
-
Standard Operating Procedure
QA
-
Quality Assurance
N.A
-
Not Applicable.
PR
-
Production
W/v
-
Weight/Volume
Revision History:
Revision No
00
Format No.SPL/QA/001
Effective date
Reason for Revision
New Document