TESTING INTEGRITY

TESTING INTEGRITY:

TESTING INTEGRITY M.Sahithi M.Pharmacy Pharmaceutics

Introduction:

Introduction The need to check package integrity has increased in importance both to guarantee product shelf life and to ensure that the product has not become contaminated from some external source. INTEGRITY TESTING BUBBLE TEST: blister/strip pack, liquid bottles/cap PRESSURE DECAY TEST: vials, ampoules, blister, pouches IV bags VACCUM DECAY TEST: vials, ampoules DYE PENETRATION LEAK TEST

BUBBLE TEST:

BUBBLE TEST Bubble test also called as AIR UNDER WATER(AUW) test Detect medium to large leaks Does not quantify the leak rate Do not use this method at low pressure

PROCEDURE:

PROCEDURE Immerse test package in a container containing colored water(15-25◦c) Place the container in the vacuum chamber. Apply vacuum of 33kpa(250 mm of hg)-strip packs or 24kpa for (180 mm of hg) blister packages for 30 sec Restore atm pressure and remove the container from the vacuum chamber. Remove test package from the container and blot off the excess water. Examine the package for ingress of water into packets

Continuation……………………:

Continuation…………………… Limitations Labor intensive process AUW equipment must maintain clear water including water cleaning systems and expensive lightening system. It is destructive type leak detection method.

Pressure or vacuum decay chamber testing:

Pressure or vacuum decay chamber testing Test item must contain some air other gas inside(head space) It detects leaks from pin holes, crack seals in the walls of ampoules, blisters and vials. It is non destructive type leak detection method.

Procedure:

Procedure Creating a closed space around the test item(a surrogate chamber) and pressurizing or evacuate it. A pressure deferential can thus be created across the package walls or seals. Once stabilized, air movement from higher pressure to lower pressure will indicate the presence of leak path. Air volume around test substance used to detect change in the chamber pressure by leak detector.

Equipments:

Equipments

Dye penetration leak test:

Dye penetration leak test The ampoules or filled glass containers are placed in to the dye bath. The contents of the defective ampoules are colored by dye bath at a specific pressure deferential (15 to 30 mns). The ampoules treated in dye bath are checked for discoloration after a washing process.

Contin……………………..:

Contin …………………….. Limitations Destructive type leak detection method Recognisation of cracks in ampoules is incomplete and unsatisfactory Only slightly discolored ampoules are not recognized and separated

Equipments:

Equipments Vial leak detector Blister card leak detector

References:

References Pharmaceutical packaging technology by D .A DEAN E.R EVANS I.H HALE www.pharma info. net www.acg world.com

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