SOP on Procedure for Leak Test

April 6, 2016September 12, 2024 Pharmaceutical Guidanace

Objective: To lay down a procedure for Leak Test.

Scope:This standard operating procedure is applicable for formulation plant of Pharmaceutical company name with location.

Responsibility

Production Supervisor / Officer shall be responsible for implementation of the procedure mentioned in this SOP.

Head, Production shall be responsible for compliance of procedure as per SOP.

Abbreviations and Definitions

SOP – Standard Operating Procedure

QA – Quality Assurance

BPR – Batch Packing Record

Procedure

Strip / blister sealing leak test shall be performed on a suitable leak test apparatus.

Take strip / blister from one full round of sealing roller / sealing plate but not less than 10 continuous strips as sample from the machine at the time of start and then at an interval of 2 hours, while re-starting (during operation after lunch / dinner break) and at the start of new roll.

Place the strip / blister into the vacuum desiccator of leak test apparatus containing enough purified water to cover the strip / blister. In case of Alu-Alu peelable blister pack, blisters equivalent to one sealing stroke to be dipped in water.

Close the desiccator and start the vacuum pump and keep strip / blister under vacuum of about 15 inches of mercury for 30 seconds or as mentioned in respective BPR.

Slowly release the vacuum by rotating the knob of vacuum desiccator and remove the strip / blister.

Carefully wipe the strip / blister with tissue paper or clean non-shredding cloth for removal of water.

Examine all the pockets for any leakage by opening the pockets manually.

If any one pocket shows evidence of leakage, reject the sample, stop the Blister / Strip machine and immediately take corrective action. Again run the machine and then take double number of strips / blister and again repeat the leak test.

If no leakage is detected then restart the machine. If leakage of any sample is still evident, adjust the machine and perform retesting until the process is under control and record the result.

During leak test examination the rejected tablets / capsules from tested samples shall be discarded.

Forms and Records

Not Applicable

Distributions

Master Copy – Documentation Cell (QA)

Controlled Copies –Production, Quality Assurance and Quality Control

History

Date	Revision Number	Reason for revision
–	00	New SOP

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