SOP FOR SIEVE INTEGRITY TEST

  1. OBJECTIVE

            To lay down the procedure for sieve integrity test.

  • SCOPE

      This SOP is applicable for sieve integrity test in Production Department.

       RESPONSIBILITY

           Production Chemist & operator      : To follow the procedure

      ACCOUNTABILTY:

QA & Head Production                  : For system compliance

  •       PROCEDURE
    • To ensure the sieves are checked as per defined procedure.
    • To ensure proper numbering of the sieves.
    • All sieves should be checked visually by the operator / Manufacturing chemist, against a uniformly white or black background for any defect, blinding or contamination, before and after use and details shall be recorded.
    • The visual checks should identify any damage, scoring, blinding or contamination, likely to affect the performance of the sieve.
    • It is important that the condition of the molded edges of the sieves should be checked.
    • Damaged wires or any part that comes under powder should be checked.
    • Gaps in loosened or slackened wire mesh should be checked
    • Rusting of wires should be checked
    • QA chemist should verify the details and enter the observations in BPCR.
  • Sieve MaintenanceSieves should not be overloaded during screening as it leads to sagging of the wire mesh, distortion of aperture sizes & tearing of the screen.
  • Sharp or blunt metallic objects should not be used on the screen surface.
  • Application of downward pressure by a gloved hand should be avoided as it leads to over sizes passing through & sagging of the sieve.
  • Care should be taken while cleaning the wire mesh as hard scrubbing will lead to distorted apertures & screen damage.
    • Note: Always use the hand gloves during handling of sieves.

TRAINING

Trainer   : Head – Production Department

 Trainees : Staff and machine operator of production and QA chemist.

     DISTRIBUTION

Master Copy                     :          QA Department

Controlled Copy               :          Production Department  

Display Copy                    :           Production Department (If Required)

ATTACHMENTS

Sr. No.        Annexure No. Title Format No.
1 NA NA NA
  • REFERENCES        

In-house

  ABBREVIATION

Abbreviation Extended Form
EG Engineering
SOP Standard Operating Procedure
 QA Quality Assurance
WH Warehouse
NA Not Applicable
MB Microbiology

      REVISION HISTORY OF CHANGE

Sr. No. Date Revision Details Revision No.

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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