SOP FOR CLEANING AND OPERATION FOR CAPSULES VISUAL-INSPECTION MACHINE

  1. OBJECTIVE

          To lay down the Procedure for Cleaning and operation for Capsules Visual inspection Machine

2.0     SCOPE

         This SOP is applicable to Cleaning and operation for Capsules Visual inspection.

3.0   RESPONSIBILITY

        Production Chemist & operator      : To follow the procedure

4.0   ACCOUNTABILTY:

         QA & Head Production                  : For system compliance

  •     PROCEDURE
    •  Cleaning
      • Affix the status label “UNDER CLEANED” to the capsules inspection machine dully filled and signed by competent technical staff. Remove the capsules of the previous batch if remains.
      • Remove the previous product identity from the capsules Inspection Machine.
      • Clean the Capsule inspection machine with dry lint free cloth and moping with 70% IPA solution.
      • Affix the status label “CLEANED” to the capsules Inspection Machine dully filled and signed by competent technical staff.
      • Enter the cleaning record in respective Log Book
    • Operation :
      • Ensure the cleanliness of Capsules Visual inspection Machine and conveyor belt.
      • Get the line clearance from IPQA chemist before starting the operation.
      • Switch ON the Capsules visual inspection light.
      • Switch ON the conveyor belt and set the speed of conveyor as per outlet speed of capsules.
      • After completion of process switch OFF the Light and switch OFF the conveyor belt.
      • Before beginning of activity and at the end of the day/shift activity clean the area.

6.0 TRAINING

Trainer   : Head – Production Department

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

7.0       DISTRIBUTION

Master Copy                     :           QA Department

Controlled Copy               :           Production Department  

Display copy                     :           Production Department (If required)

8.0 ATTACHMENTS

            Nil

  • REFERENCES 

In-house

10.0 ABBREVIATION

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

      11.0 REVISION HISTORY OF CHANGE

Sr. No. Date Revision Details Revision No.
1 NA New SOP 00

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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