SOP ON BIO-BURDEN OF PACKING MATERIAL

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SOP ON BIO-BURDEN OF PACKING MATERIAL

OBJECTIVE:

The purpose of this SOP is to lay down the procedure for the bioburden of packing material.

SCOPE:

This SOP is applicable for bioburden of packing material at the Pharmaceutical manufacturing facility.

RESPONSIBILITY:

An authorized designee of the microbiology department shall be responsible for testing & documentation of bioburden of packing material.

Head of Microbiology is responsible for effective implementation of the SOP.

PROCEDURE:

  • APPARATUS:
               LAF
               Colony counter
               Incubators
  • For PVC, PVDC Film, Plain Aluminum Foil, Printed Aluminum Foil, Polythene Bag And Container:
  • For Printed Aluminum foil, Plain Aluminum foil, PVC film, PVDC film, discard first one meter Roll and sample another one meter as a sample of the film / Foil under LAF and for Polythene bags, one bag from each bundle and 5 No. of samples from Container.
  • Determine the bioburden of the packaging material by contact plate method with the help of the RODAC plate, having sterile media or by using the membrane filtration method.
  • Determine the Bioburden on PVC, PVDC, Printed Aluminum foil, Plain Aluminum foil and by contact plate method using SCDA RODAC plate, on the inner surface area. For polythene bag, rinse method shall be used.
  • Aseptically open the RODAC plates under LAF and take the impression of the respective sample of packing material and close the plates.
  • Keep one plate as such for Negative control
  • Incubate the plates at favorable condition five days.
  • Container testing follows the method of membrane filtration.
  • Give a rinsing of not more than 100 ml sterile 0.1% peptone water to 5 no. The rinsing volume should be such that the rinse of the complete inner surface is taken. Filter the rinsing solution through a sterile 0.45μ membrane filter. Finally, rinse the container with 3 x 100 ml of peptone water. Place the membrane filter aseptically on the surface of the SCDA plate.
  • For closure above mentioned rinse method is used.
  • For negative control filter, 100 ml 0.1 % peptone water keep the filter in SCDA plate
  • Incubate the plates at the favorable condition for Five days.
    • Frequency:

Once in a year for the first Five consignments of each vendor.

  • Limits:

In-house Limits should be used.

For Printed Aluminum foil, Plain Aluminum foil, PVC film & PVDC film

Total Aerobic Microbial Count (TAMC):  NMT .. CFU / 25 cm2

Total Yeast and Mould Count (TAMC): NMT .. CFU / 25 cm2

For Container / Closure / Polybag

Total Aerobic Microbial Count (TAMC):  NMT .. CFU / 5 No.

Total Yeast and Mould Count (TAMC):  NMT .. CFU / 5 No.

  • TRAINING:

As Per Training SOP

  • DISTRIBUTION:

As Per Documentation Control SOP

  • ANNEXURE(S):

Annexure-I: Bioburden of Printed/Plain Aluminum foil

Annexure-II: Bioburden of PVC/PVDC film

Annexure-II I: Bioburden of Polythene bags

Annexure-IV: Bioburden of Container

Annexure-V: Packing Material Inward Log

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