Defects in Packaging


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Defects in Pharmaceutical Packaging:

Defects in Pharmaceutical Packaging Guided by - Prepared by – Dr.Gopal Rai Vaibhav Patel GRKIST (Pharmacy) Apoorva Sahu Jabalpur M- Pharma GRKIST, JBP

Classification of defects in packaging :-:

Class A – Critical Defects Critical defects are those which prevents a package from performing its intended function of protecting its contents. It also prevents from compliance of regulatory region that causes hazards in handling or disposal. The acceptance quality level (AQL) for critical defects is 0 i.e. container or closure has to be rejected. Cracked or chipped glass bottle Fracture in can Puncture in pouch Missing liner in closure Classification of defects in packaging :-

Class B – Major Defects:

Major defects are those which cause borderline functionality in a package. It reduces the identity of a packaging system by virtue of graphic defects. The acceptance quality level (AQL) for major defects is 0.15 to 1.50. Missing colour in lithography Cartons out of square Heat seal is too narrow Blotted printing in aluminum foils Class B – Major Defects

Class C – Minor Defects:

Minor defects are those which impair the appearance but not the function of package. These defects are also called as appearance defects. The acceptance quality level (AQL) for minor defects is 4.0 to 6.5 . Stones or air bubbles in glass bottles Small dents & scratches on can Cap colour is off standard Printing out of register Scratches on the aluminum foil Uneven outer surface of bottle Class C – Minor Defects

Defects in Sterile Products:

Some common defects which are observed in pharmaceutical vials, ampoules, I.V. bags, pouches etc. are given below :- Delamination Incomplete seal Crooked seal Abrasion Contamination Hot fold sealing Chipped surface Defects in Sterile Products

Defects in Liquid Products :

Liquid preparations like emulsion, suspension, solutions, syrups are generally dispensed in bottles which are prepared by glass or plastics. The defects which are generally observed in these products are as follows :- Chipped surface Bulge Spike Blotting Missing liner Crack Defects in Liquid Products

Defects in Solid dosage forms :

Solid dosage forms like tablet, capsule, pills are generally packed in blister packs & strip packs. The common defects observed in this class are as follows :- Seal defects Blotted printing Pin holes Blocking Embedded foreign matter Scratches on lamination Mould lines Defects in Solid dosage forms

Main causes of defects :-:

Joint or material failures are potential problems. If the packaging material is not sufficiently strong, then failure can occur as a collapse, rupture, tear or crack. Closures are also responsible for packaging defects. Sometimes packaging machines are not set correctly, thereby producing thousands of out of specifications packages . Main causes of defects :-

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