1.0 PURPOSE:
To lay down the procedure for cleaning of new equipment.
2.0 SCOPE:
This procedure for cleaning of new equipment is applicable in Production Injectable, Warehouse and Production OSD area at (Company name).
3.0 DEFINITIONS:
Nil.
4.0 RESPONSIBILITY:
4.1 Production/Warehouse operator is responsible for the Cleaning of new equipment’s.
4.2Production/Warehouse Officers/Executives are responsible for execution of the procedure.
4.3 Head – Production/Warehouse is responsible to ensure the compliance of the procedure.
5.0 PROCEDURE:
5.1 Arrange to clean the new equipment in RM and PM Loading/unloading bay before taking into the processing area.
5.2 Checking and verifying supporting document like packing list and qualification documents etc. Proceed for further activity.
5.3 Remove all the packing components fiberboards, thermocol, plastic covers etc. used for the shipment at RM and PM Loading/unloading bay.
5.4 Thoroughly dedust the equipment preferably with the help of vacuum cleaner and wipe with clean cloth.
5.5 Arrange for shifting of equipment/accessories at desired location in the processing area.
5.6 Affix the “Equipment/Instrument status label” on the equipment.
5.7 Use filtered 70% IPA solution for critical area and unfiltered 70% IPA for noncritical area to remove the stains if any.
5.8 Clean the equipment’s with lint free cloth dipped in WFI/Purified water.
5.9 Use an appropriate Nylon Brush/Nylon Scrubber as required.
5.10 Clean the equipment’s with lint free cloth dipped in purified water/water for injection until it looks visually clean.
5.11 Collect the rinse sample from the equipment, if applicable.
5.12 Check the conductivity of the rinse sample. It should be below the conductivity of purified water/WFl on that particular day.
5.13 Dry the equipment with 0.2 micron filtered compressed air/ dry lint free cloth.
5.14 Inform to QA to check the equipment/accessories for cleanliness visually.
5.15 If cleaning is not satisfied then follow the cleaning procedure from 5.8 to 5.14.
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure.
IPA : Iso propyl alcohol.
% : Percentage
RM : Raw material
PM : Packing material
WFI : Water for injection
OSD : Oral Solid Dosage
QA : Quality Assurance
7.0 REFERENCES:
Nil.
8.0 LIST OF ANNEXURES:
Nil.