sop for Cleaning of Blister packing machine
1.0 OBJECTIVE :
• To lay down a procedure for Cleaning of Blister packing machine
2.0 SCOPE :
• This procedure is applicable for Cleaning of Blister packing machine for production
3.0 RESPONSIBILITY:
• Operator – To perform the procedure. Head Officer
• Production: Officer /
• Production: To ensure that the operation is being performed in compliance with the
SOP.
4.0 PROCEDURE:
4.1 TYPE I CLEANING
(Change over from one batch to next batch of the same product, same potency and of similar product with ascending potency provided the color is same.)
• Ensure that all the materials of previous batch are removed from the blister-packing cubicle.
• Ensure that the power supply and compressed air supply are put off.
• Replace the ‘under process’ status label by ‘to be cleaned’ status label then ‘under cleaning’ Label while beginning the cleaning procedure.
• Clean the machine with dry lint free cloth.
• Clean the forming upper & lower platen, hopper, linear vibrator feeder part, Upper & lower sealing platen, embossing tool, perforation tool, punching tools, acrylic cover and guards with a dry lint free cloth.
• Affix the “cleaned” label on the machine with date and sign of the production officer as per SOP.
• Record the Start time and end time of cleaning in equipment usage log book and Clean the area as per SOP.
• Maintain The Type I Cleaning Checklist As Per Annexure I.
4.2 TYPE II CLEANING
(During changeover of product with different actives/color/descending potency or after maintenance of contact parts.)
• Replace the ‘under process’ status label by ‘to be cleaned’ status label then ‘under cleaning’ while starting the cleaning procedure.
• Ensure that the power supply and compressed air supply are turned off.
• Product contact parts like upper forming platen to be clean with nylon brush when cool, to eliminate any collected deposit on the surface of the platens. Use 70% IPA for the removal of adhered dried PVC.
• Clean the hopper/linear vibrating parts with lint free cloth dipped in purified water and then followed by dry lint free cloth.
• Remove entire change part assembly from the basic feeder unit. Wash the assembly with purified water and dry with lint free cloth and then reassemble it.
• Clean the sealing plate with Copper wire brush if the knurling has been stopped.
• Ensure cleaning of Embossing tool, perforation tool, punching tool shall be clean by dry lint free cloth before and after every batch.
• Acrylic covers and guards shall clean with Teepol followed by purified water and dry with lint free cloth. Dry the cleaned parts with a dry lint free cloth.
• Wipe the destroyed parts with 70% v/v IPA solution.
• Clean the internal and external surface of the machine, control panel and utility lines with a dry lint free cloth. Clean the machine with 70% v/v IPA solution.
• Reassemble the cleaned hopper, channel and hopper lid.
• Affix the ‘cleaned’ status label with date and sign of the production officer.
• Record the Start time and end time of cleaning in equipment usage log book and clean the area as per SOP No.
• Maintain the Type ‘II’ Cleaning As Per Annexure II.
5.0 ABBREVIATION (S):
• PVC : Poly vinyl chloride
• v/v : Volume/ Volume
• IPA : Isopropyl alcohol
• QC : Quality Control
• IPA : Isopropyl alcohol
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