SOP for Changeover in Manufacturing and Packing Area

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 logo pp Title : STANDARD OPERATING PROCEDURE Page : Page 1 of 5
Effective date :
Number : 001 Supersedes :
Review date :
CHANGE OVERS IN MANUFACTURING AND PACKAGING AREAS

1.0 OBJECTIVE :
The objective of this SOP is to provide written guidelines for the changeovers in manufacturing and packaging areas.
2.0 SCOPE :
The scope of this SOP is applicable for changeovers in manufacturing and packaging areas.
3.0 RESPONSIBILITY :
Operator / Pharmacist
4.0 PROCEDURE
4.1 Batch to batch changeovers for same product
LEVEL – I CLEANING
4.1.1 Batch to batch change over is change over from one batch of product to next batch of same product in granulation, compression, coating or packaging section.
4.1.2 For individual equipment, first ensure that the process of that batch on that particular equipment is complete, and the product is removed and transferred further for next stage.
4.1.3 Remove all the residual products like granules, fines, tablets, strips, stereos, labels and printed packaging materials from the equipment and the area.
4.1.4 Remove the status label of the previous batch.
4.1.5 Label the respective area as “ Area under cleaning”.
4.1.6 Clean the glass window using dry lint free cloth.
4.1.7 Clean the base of the machine using dry lint free cloth.
4.1.8 Remove the oil spillage if any on the floor and from the base of the machine with cotton waste and dispose off in dust bin.
4.1.9 Clean the floor using floor cleaning machine and mop assembly as per SOP
4.1.10 Clean the equipments as per their respective SOP’s.
4.1.11 Get the area and the equipment visually certified by the pharmacist and the IPQC person.
4.1.12 Affix the status label for the next batch in specified Format.
4.2 Procedure for week end cleaning between batch of the same product during a campaign and for product changeover
  LEVEL – II CLEANING
4.2.1 Remove the processed product from the area for further processing or storage.
4.2.2 Remove all the residual products like granules, fines, tablets, strips stereos, labels and packaging materials from the equipment and the area.
4.2.3 Label the respective area as “Area under cleaning”
4.2.4 Vacuum clean the ceiling.
4.2.5 Clean the tube light fixtures as per SOP.
4.2.6 Clean the walls, doors and the edges with vacuum cleaner.
4.2.7 Vacuum clean the AHU sipply and return grill.
4.2.8 Clean flexible pipes as per respective SOP.
4.2.9 Clean the glass windows and pass box with dry lint free cloth.
4.2.10 Clean the waste bin with potable water followed by purified water in general wash area.

Wipe out the waste bin with dry lint free cloth from inside and outside.

4.2.11 Clean lifting and positioning device as per SOP.
4.2.12 Clean dust extractor pipe as follows :
4.2.12.1 Open thetriclover fittings and dismantle the dust extractor pipe.
4.2.12.2 Clean the pipes with potable water  and scrub with long handle brush in the same area.
4.2.12.3 Clean the pipes with hot potable water and scrub pipe with long handle brush if required.
4.2.12.4 Rinse the pipes with purified water
4.2.12.5 Wipe the internal surface of pipe with long handle brush cover with dry lint free cloth.
4.2.12.6 Wipe the external surface of pipe with clean and dry lint free cloth.
4.2.13 Clean the equipments and the area as per related SOPs.
4.2.14 Clean the vacuum cleaner as per SOP.
4.2.15 Clean the ladder used  as per SOP.
4.2.16 Clean the floor and underneath of the equipment using floor cleaning machine and mop assembly as per SOP.
4.2.17 Label all the equipment as ‘Cleaned’.
4.2.18 Pharmacist to ensure that the area and equipments are properly cleaned.
4.2.19 Record the activities in the area log book.
4.2.20 Affix the ‘Cleaned ‘ label.
5.0 REFERENCE :
Prepared by : Checked by : Approved by :
Date : Date : Date :
 

 

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