STANDARD OPERATING PROCEDURE

T I T L E :SOP FOR PACKAGING INTERGRITY- LEAKAGE TEST

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/164 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

PACKAGING INTEGRITY- LEAKAGE TEST

PROCEDURE
APPROVED BY: SIGN & DATE
Kevin Mochama
(Quality Control Manager)
(Prepared By)

Nancy Mwangi
(Ass. Quality Assurance Manager)
(Reviewed By)
Lucycaster Muoti
(Quality Assurance Manager)
(Reviewed By)

Vikrant Chowgule
(Head Quality)
(Approved By)

REVISION HISTORY

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 STANDARD OPERATING PROCEDURE
T I T L E :SOP FOR PACKAGING INTERGRITY- LEAKAGE TEST

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/164 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

Revision No. Revised Page(s) Description Date

00 00 Original issue 01.03.2021

PURPOSE:

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 STANDARD OPERATING PROCEDURE
T I T L E :SOP FOR PACKAGING INTERGRITY- LEAKAGE TEST

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/164 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

To lay down a procedure for testing air leakage of package to see whether, the sealing is tight or not.

SCOPE:

This procedure is applicable to infusion giving set pouch

RESPONSIBILITY;

QC-Is responsible for executing the process.

DEFINITION OF TERMS
Package Integrity-it is the physical capability of a given package to protect its contents with the
desired level of protection over a defined period of service.(ASTM F17-08)
Seal Integrity-the integrity of seals on packaging for new product introductions and alternate
distribution ,such as via e-commerce, also needs to be assessed .Maintain the reliability of package
seals is critical for product quality and food safety.
PROCEDURE:
 Seal both sides of the pouch.
 Attach 2x2 cm. of adhesive tape on sample.
 Insert needle into package through the adhesive tape and immerse the sample in water box
immediately
 Apply pressure at 0.1kgf/cm²G. In 10sec., increase the pressure to 0.2kgf/cm²G in 10 sec and
0.8 kgf/cm²G in 10 sec.
 Record the result of pressure which make leakage, If the result of pressure causing leakage to
the package was more than 0.1kgf/cm²G in 10 sec., record “>0.1”.
 Record the result of pressure which make leakage.
 Report the results of testing included average value (X) and range (R) shall be recorded in
“Inspection Certificate of each product” or “Record of testing results”.

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 STANDARD OPERATING PROCEDURE
T I T L E :SOP FOR PACKAGING INTERGRITY- LEAKAGE TEST

PROCEDURE NO.: ISSUE DATE: EFFECTIVE DATE: NEXT REVIEW DATE:

RHEL/QA/SOP/164 01/03/2021 01/03/2021 01/03/2023

REVISION NO.:00

REFERENCE:
ASTM F17-08
ABBREVIATIONS:
SOP: Standard Operating Procedure
Q A : Quality Assurance
QC : Quality Control
N/A : Not applicable
>:Greater than

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