Package validation

i want some information about package validation for HDPE canister

Dear Tarek,

Basically you can include:

Primary :

  1. Proper insertion of dessicant/cotton/rayon etc into bottle.
  2. Functioning all relevent sensors , its challenge test during different speed.
  3. Quality of your bottles, physical observation ,capping quality, leak tests, torque values.
    4.Fill counts with respect to speed, min and max
    5.Normal functioning of filling machine


  1. Downstream speed.
  2. All labeling checks and recording information
  3. All test as per inprocess checks of BPR.

AQL Checks.


Variable packaging process/Input materiel parameter would help us for HDPE type package validation.

Bottle size(Capacity),
Pack count (No of dosage form per bottle),
Type/size of closure,
No of desiccant(pouch/barrel form) per bottle,

However other than above mention variable, we need to check many challenge test for each & every step which have come cross for packaging process i.e. Filling , counting, desiccant inert, cotton insertion, torque value for opening and closing ,power % value etc.

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