1.0 OBJECTIVE: To lay down a procedure for cleaning of new equipment/machinery / in-process product containers/accessories received.
2.0 SCOPE: This procedure is applicable to the cleaning of new equipment/machinery / In-process product containers/accessories in the production department.
3.0 RESPONSIBILITY:
Officer, Executive – Production Department
Manager – Production Department
4.0 DEFINITION(S): Accessories: Sieves, screens. Spatulas, scoops SS jugs, SS buckets, SS pellets, SS containers, IPC, SS trolleys, SS dustbins, SS furniture, etc.
5.0 PROCEDURE:
5.1 De-dust the New equipment/machine / in-process product container/accessories by using a vacuum cleaner for any adherent dust.
5.2 Rub the inner and as well as an outer surface with maize starch to remove the black particles or foreign matters generated during the buffing process at the manufacturer site.
5.3 Clean the equipment/ machine / in-process product container/accessories with purified water to remove the traces of black particles or foreign matters and Starch.
5.4 Dry the equipment by using a fresh laundered lint-free cloth.
5.6 Finally wipe the inner and outer surfaces of the equipment/machine / In-process product container with freshly laundered lint-free cloth dipped in 70 % Isopropyl alcohol (IPA).
5.7 Put ‘CLEANED’ status label having Unit, Department, Equipment name, Cleaned by, Checked by Production Officer, Date and finally certified by Quality Assurance (QA).
Note: For new equipment/machine / In-process product container, update the labels with Previous Product and Batch No. will be written dash (-).
Related SOP: SOP on Decontamination of used Material Contacted with API
6.0 ABBREVIATION(S):
IPA: Isopropyl Alcohol
QA: Quality Assurance
SS: Stainless Steel
Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has experience in Pharma manufacturing and has worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don’t hesitate to reach out via email at Contact@pharmaguddu.com.