Share Report Abuse Next Blog» Create Blog Sign In cGMP and Regulatory Updates This Blog is created for the updation of knowledge on current Good Manufacturing Practices (cGMP) and current Updates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs) for any Pharma plant. FRIDAY, OCTOBER 31, 2008 Procedure for Leak testing of strips / blisters 1.0 OBJECTIVE To lay down a procedure for leak testing of strips / blisters. 2.0 SCOPE All packing areas. 3.0 RESPONSIBILITY Production officer. 4.0 ACCOUNTABILITY Production executive 5.0 PROCEDURE 5.1 Take the required number of strips / blisters as mentioned in the Annexure – I. Check the quality of strips/ blisters for any damages. 5.2 Tie the collected strips / blisters with a rubber band. 5.3 Ensure that all strips / blisters are dipped in water and close the lid. 5.4 Connect opening of the desiccator to the vacuum pump. 5.5 Apply a vacuum of 300 mm of Hg and close the knob of the desiccator. 5.6 Keep the vacuum for 30sec. 5.7 Release the vacuum by opening the knob of the desiccator slowly and open the lid remove the strips / blisters. 5.8 Wipe out the traces of water from the strips / blisters by using lint free duster . 5.9 Open the pocket of strips by using scissors to remove the tablets / capsules. 5.10 Open the blisters manually. Subscribe via email Enter your email address: Subscribe Delivered by FeedBurner FeedBurner FeedCount Blog Archive ► 2010 (18) ► 2009 (165) ▼ 2008 (376) ► December (43) Search Ads by Google Soil Testing Gas Leak Test Glucose Test Strips Leak Testing Hose Testing Calibration Testing METTLER TOLEDO calibrations meet ISO9001, ISO17025 & other standards www.mt.com/calibrationservice Blister Packaging Blister Machines Continuous Blister Packaging www.ulmapackaging.com Leak Test made easy Quick Connectors for high pressure leak testing of auto components www.weh.in/quick-coupling.html Great Lakes Vacuum We rebuild & repair vacuum pumps, blowers & also stock oil and parts! www.greatlakesvacuum.com Portable Vacuum Pump Economical,Cool & Quite, Long Life Versatile, Tough, Light weight ColeParmer.in/Vacuum_Pumps Water Sensor Switch Detect water leaks from 1/16 inch. Alarm or control based on detection www.antx.com 5/3/2010 cGMP and Regulatory Updates: Procedu… …vinvarun.biz/…/procedure-for-leak-tes… 1/7
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Share Report Abuse Next Blog» Create Blog Sign In
cGMP and Regulatory UpdatesThis Blog is created for the updation of knowledge on current Good Manufacturing Practices (cGMP) and currentUpdates from all regulatory authorities. Also one can archive Standard Operating Procedures (SOPs) for anyPharma plant.
FRIDAY, OCTOBER 31, 2008
Procedure for Leak testing of strips /
blisters
1.0 OBJECTIVE
To lay down a procedure for leak testing of strips / blisters.
2.0 SCOPE
All packing areas.
3.0 RESPONSIBILITY
Production officer.
4.0 ACCOUNTABILITY
Production executive
5.0 PROCEDURE
5.1 Take the required number of strips / blisters as mentioned
in the Annexure – I. Check the quality of strips/ blisters for any
damages.
5.2 Tie the collected strips / blisters with a rubber band.
5.3 Ensure that all strips / blisters are dipped in water and close
the lid.
5.4 Connect opening of the desiccator to the vacuum pump.
5.5 Apply a vacuum of 300 mm of Hg and close the knob of the
desiccator.
5.6 Keep the vacuum for 30sec.
5.7 Release the vacuum by opening the knob of the desiccator
slowly and open the lid remove the strips / blisters.
5.8 Wipe out the traces of water from the strips / blisters by
using lint free duster .
5.9 Open the pocket of strips by using scissors to remove the
tablets / capsules.
5.10 Open the blisters manually.
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▼ 2008 (376)
► December (43)
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