Operation of Pin Hole apparatus

  1. Objective

To lay down a procedure for operation of Pin Hole apparatus.

  •       Scope

This SOP is applicable in Quality Control for operation of Pin Hole apparatus a. This apparatus is used for checking of Pin Holes in blister foil, PVC, PVDC and Aluminum foil.

  •       Responsibility

      Chemist QC    :  To follow the procedure                              

  •       Accountability

       Head – QC     :  For system compliance

  •        Procedure
    • Ensure that apparatus is clean.
    • Cleaning:- Clean the apparatus with lint free cloth, daily.
    • Switch ON the mains. Tube lights will glow.
    • Ensure that all the tubes light are glowing.
    • Place a piece (1 or 2 meters sample) on the glass and check the light. If emitting through pin holes. Record the observation in respective record book.
    •      Precaution:
      • Do not apply much force or give any shock to the PIN HOLE apparatus during detecting PIN HOLES.
      • Room light shall be switch off.
      • Don’t apply force on glass.
    •      Take three test in three various portion of the same specimen and find out the average numbers of holes. Record the observation in respective protocol.

If PIN HOLES are suspected only on outer layer, it shall be confirmed by a machine trial for leak test.  If there is no leakage approve the materials.

After completion of test, switch OFF the mains.

Clean with lint free cloth.

Annexure (S)

NA

  • References (S)

In – house

  • Glossary

SOP                :          Standard Operating Procedure

QC                  :          Quality Control

QA                   :           Quality Assurance     

  • Revision History
Rev. No. Details of changes Reason for change

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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