1.0 PURPOSE:
2.0 SCOPE:
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Production operator is responsible to follow the SOP.
4.2 Production officer / executive is responsible for execution of the procedure.
4.3 Head-Production is responsible to ensure compliance of the procedure.
5.0 PROCEDURE:
5.1 Handling of Uncleaned Equipment and accessories:
5.1.1 In case of granulation, after completion of batch do the WIP of granulation line remove the equipment parts like screens, sampling devices and accessories for which already WIP is completed and packed in double polybag and label as “TO BE CLEANED”.
5.1.2 Send the equipment parts like screens, sampling devices and accessories into granulation wash area for cleaning.
5.1.3 In case of coating, after completion of batch do the WIP of auto coater remove the equipment parts like baffles, silicon pipes and accessories for which already WIP is completed and packed in double polybag and label as “TO BE CLEANED”.
5.1.4 Send the equipment parts like baffles, silicon pipes and accessories into suspension preparation area for cleaning.
5.1.5 In case of other area expect granulation and coating, after completion of batch put the uncleaned accessories in double polybag and label as “TO BE CLEANED”.
5.1.6 From corridor, the uncleaned equipment and accessories should transfer it to uncleaned equipment hold area.
5.1.7 From uncleaned equipment hold area, the equipment and accessories should transfer to wash area for cleaning.
5.1.8 In wash area equipment and accessories shall be cleaned by using potable water followed by purified water as per respective SOP.
5.1.9 After completion of washing, it shall be transferred to drying area for drying, where the equipment and accessories will dry by 0.2 p filtered compressed air to remove water droplet from the equipment.
5.2 Frequency for cleaning of uncleaned equipment and accessories:
5.2.1 Equipment and accessories can be kept in uncleaned condition upto 5 days from the day of activity end.
5.3 Usage:
5.3.1 If an equipment or accessory is under continuous campaign then in the 5th day after completion of the campaign the equipment or the accessory will be subjected to cleaning.
5.4 Status:
5.4.1 Equipment or an accessory will be labeled as “TO BE CLEANED” till 5 days from the day of activity end. Then after 5 days the label should be changed to “CLEAN BEFORE USE” label.
5.5 Handling of Cleaned Equipment and accessories:
5.5.1 After completion of drying the equipment, affix the “CLEANED” label.
5.5.2 For accessories after drying, it should be transferred into the cleaned equipment hold room and can be stored in the area till next use.
5.5.3 Put the equipment into a polybag or stretch wrap it with stretch film.
5.5.4 Put it on the trolley.
5.5.5 For equipment, after the cleaning activity is completed check it for dryness.
5.5.6 Record the cleaning activity in area /equipment cleaning log.
5.6 Frequency for handling of cleaned equipment and accessories:
5.7 Usage:
5.8 Status:
5.8.1 Equipment or an accessory will be labeled as “CLEANED” till 5 days from the day first cleaned. Then after 5 days the label should be changed to “CLEAN BEFORE USE” label.
Note: In case of granulation line/dry co mill/coater, it shall be cleaned by using CIP where as in case of IBC bins/HC-ECM of compression machine, deduster and metal detector shall be transferred to wash area for cleaning with “TO BE CLEANED” label.
In case of blister and bottle line machine all contact parts shall be packed in double polybag and shall be transferred to wash area / packing change parts cleaning room for further cleaning with “TO BE CLEANED” label.
6.0 ABBREVIATION:
SOP : Standard operating procedure
CIP : Clean in place
IBC : Intermediate bulk container
HC-ECM : High containment exchangeable compression module
µ : Micron
7.0 REFERENCES:
Nil.
8.0 LIST OF ENCLOSURE:
Nil.
Also read: Procedure for cleaning of new equipment.
Also read: SOP for Critical Area Practices.