1.0 OBJECTIVE:To lay down the cleaning procedure for capsule filling cubicle.
2.0 SCOPE:This SCP shall be applicable for capsule filling cubicle in Production department.
3.0 RESPONSIBILITY:3.1 Execution :Operator
3.2 Checking :Pharmacist and Above
5.0 PROCEDURE:5.1 Procedure for cleaning between batches of same product
LEVEL- I CLEANING5.1.1 Ensure that all material, used labels, product residue and documents of previous batch are removed from the cubicle.
5.1.2 Label the respective area as “Area under cleaning”.
5.1.3 Clean the glass window using dry lint free cloth.
5.1.4 Clean the base of machine using dry lint free cloth.
5.1.5 Remove the oil spillage if any on the floor and from the base of the machine with cotton waste and dispose off in waste bin.
5.1.6 Clean the floor using floor cleaning machine & mop assembly.
5.2 Procedure for weekend cleaning between same products during a campaign and for product changeover
LEVEL- II CLEANING5.2.1 Ensure that all material, used labels, product residue and documents of previous product are removed from the cubicle.
5.2.2 Label the respective area as “Area under cleaning”.
5.2.3 Ensure that all empty containers of previous product are transferred to general wash area.
5.2.4 Intimate engineering department for cleaning of AHU filters.
5.2.5 Clean the return riser filter as follows.
220.127.116.11 Remove & cover the return riser filter(s) with new polythene bags and affix “To be cleaned” label and transfer it to Wash room for cleaning.
18.104.22.168 Clean the filter with potable water & allow the water to drain from the filter.
22.214.171.124 Dry the filter using compressed air.
126.96.36.199 Cover the return riser filter(s) with polythene bags and affix “Cleaned” label and transfer it to Capsule filling area.
5.2.6 Clean the return riser ducts up to maximum possible height.
5.2.7 Vacuum clean the ceiling and AHU supply.
5.2.8 Clean the tube light fixtures.
5.2.9 Clean the pendent externally by wet lint free cloth, followed by dry lint free cloth.
5.2.10 Vacuum clean the wall surfaces & doors.
5.2.11 Clean glass windows with dry lint free cloth.
5.2.12 Clean the cupboards and flexible pipes respectively.
5.2.13 Clean the vernier caliper.
5.2.14 Clean the Capsule Filling Line.
5.2.15 Clean the weighing balance.
5.2.16 Clean bins/HDPE containers.
5.2.17 Clean the waste bin with potable water followed by purified water in wash room. Finally wipe out the waste bin with dry lint free cloth from inside & outside.
5.2.18 Clean the vacuum cleaner as per SCP.
5.2.19 Clean the stainless steel containers, scoops, & plastic containers as per SCP.
5.2.20 Remove the oil spillage if any on the floor and from the base of the machine with cotton waste and dispose off in waste bin.
5.2.21 Clean the floor using floor cleaning machine & mop assembly.
5.2.22 Affix label is all the equipments as “Cleaned”.
5.2.23 Cover all openings of equipments using poly bag and tie with nylon thread.
5.2.24 Record the details of cleaning in the area logbook.
5.2.25 Record the details of equipments cleaning in their respective equipment usage logbook.
5.2.26 Re-clean the area before use if not used within 72 hours.
6.0 ABBREVIATION:SCP :Standard Cleaning Procedure
IPA :Isopropyl Alcohol
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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