1. OBJECTIVE

               To lay down the procedure for cleaning and operation of Blister packing machine

• SCOPE

This SOP is applicable for Cleaning & Operation of Blister Packing machine.

• RESPONSIBILITY
  • Operator will operate and clean the Blister Packaging Machine.
  • Section Head shall be responsible for the verification of Operation and Cleaning of Blister Packing Machine and implementation of this SOP.

• ACCOUNTABILITY
  • Department Head & QA Head shall be accountable for compliance of this SOP.

5.0                   PROCEDURE

5.1                  OPERATION

• Check the status label “CLEANED” on blister machine.
• Take the approval from in process quality assurance for the cleanliness.
• Switch “ON” the main electrical supply and Blister Machine and keep compressed air valve, chilled water  

         Supply valve in “ON” position.

• Set the parameter as per data provided:
  • Compressed Air Pressure:  NLT 4.0 kg/cm²
  • Forming roller Heater:  140-160°C
  • Sealing roller Heater: 170- 200°C

• As per the details of Batch Manufacturing Record, Stick the Batch Printing Stereo on the Stereo Drum.

Load the PVC/PVDC film roll and Aluminum foil roll on respective holders.

• Pour ink to the Batch code-printing unit.
• Allow achieving the set Temperature and Pressure.
• Take out impression of the stereos on the foil and get it Approved from Q.A. and Production

           against the batch details as per Batch Manufacturing Record.

•        Set the PVC/PVDC through forming roller and after formation of cavity pass it through sealing guide roller

       and set the punching tool to get the desired shape of strip.

• Set the Aluminum foil through the sealing heater and PVC/PVDC wave and ON the pressure switch so that

       the sealing heater can seal the aluminum foil to the PVC/PVDC foil wave.

• Check the empty strip in every aspect, Blister formation, Coding and Leak Test.
• Fill the Hopper with Capsules, which are to be packed and switch on the main feeder.
• Set vibrator and in feed motor speed to ensure adequate feeding of Capsules.
• Perform the Leak Test and get Approval from Q.A. Personnel.
• Connect Blister belt and Conveyor Belt for On-line packing.
• After completion of the batch Switch “OFF” the Blister Machine.
• Affix status label “TO BE CLEANED” to the blister machine duly filled and signed by competent technical

       Staff.

• Record all the observations in Blister Machine log book.
  • CLEANING
• Affix the status label “UNDER CLEANING” to the blister machine.
• Switch “OFF” the main power supply and the Blister Machine.
• Keep compressed air valve, chilled water supply valve in OFF position.
• Clean all materials of previous batch from surrounding area and machine
• Clean hopper lid, hopper, vibrating plate, feed box, feeding roller and feeding channel with vacuum, nylon   

         brush and lint free cloth.

• Clean forming heater, forming die, guide track and pressure plate with lint free cloth.
• Clean sealing heater with brass wire brush.
• Clean Punching tool assembly with lint free cloth.
• Clean machine body, control panel, machine base with nylon brush and lint free cloth with 70% IPA.
• Affix status label “CLEANED” to the blister machine duly filled and signed by competent staff.
  • Record all the observations in Blister Machine log book.

• 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

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

  9.0 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	NA	NA