In this post Standard Operating Procedure Cleaning and Operation of Vacuum Cleaner in Pharmaceuticals is describe.
1.0 OBJECTIVE:
To lay down a procedure for Cleaning and Operation of Vacuum Cleaner.
2.0 SCOPE:
This procedure is applicable to Cleaning and Operation of Vacuum Cleaner used in Production Department.
3.0 RESPONSIBILITY:
Technical Associate - for Execution
Officer/Executive Production Department- for verification and implementation of SOP.
Head Production Department- shall ensure compliance of the SOP.
4.0 DEFINITION(S):
NA
5.0 PROCEDURE:
5.1 Cleaning (TYPE A): This is a cleaning procedure applicable for day end cleaning and for change over from one batch to next batch of the same product, same potency and of similar product with ascending potency.
5.1.1 Ensure that the power supply is put off.
5.1.2 Transfer the vacuum cleaner to washing area.
5.1.3 Dedust the body of vacuum cleaner with lint free cloth.
5.1.4 Unclamp the top lid (with motor assembly) from the container.
5.1.5 Collect and immersed the powder present in the collection container in pre-labeled polybag.
5.1.6 Destroyed the powder in to the drain point with the help of sufficient quantity of water. Deactivation of dust generating in cephalosporin block during cleaning to be done as per the SOP before discarding the powder.
5.1.7 Affix ‘CLEANED’ label dully filled and signed on the equipment.
5.2 Cleaning (TYPE B): This is a cleaning procedure applicable for Change over of product with
different actives/colour/descending potency or after maintenance of contact parts.
5.2.1 Clean the vacuum cleaner by following step no. 5.1.1 to 5.1.3 before cleaning.
5.2.2 Dismantle the hosepipe and nozzle from the container of vacuum cleaner.
5.2.3 Unclamp the top lid (with motor assembly) from the container.
5.2.4 Remove the filter, keep in a poly bag and send to the washing area for cleaning.
5.2.5 Clean the filter bag with the help of compressed air.
5.2.6 After cleaning keep the cleaned filter bag in a clean poly bag.
5.2.7 Collect and immersed the powder present in the collection container into pre-labeled double poly bag and destroyed the powder in to the drain point with the help of sufficient quantity of water. Deactivation of dust generating in cephalosporin block during cleaning to be done as per the SOP before discarding the powder.
5.2.8 Clean the container from inside and outside with purified water.
5.2.9 Dry the container using a clean dry lint free cloth.
5.2.10 Clean the hosepipe and nozzle by using purified water with a nylon brush.
5.2.11 After cleaning, keep the pipe and nozzle in inverted position so as to drain the excess water and dry the hosepipe and nozzle using compressed air.
5.2.12 Wipe the vacuum cleaner top lid by using a wet lint free cloth and then dry with a dry lint free cloth.
5.2.13 Assemble with the cleaned filter bag and the top lid to the container with the help of clamps provided in dry area.
5.2.14 Fix the hose pipe and nozzle to the container.
5.2.15 After completion of cleaning of the vacuum cleaner, affix ‘CLEANED’ label duly filled and signed on it as per reference SOP.
5.3Frequency: Clean the vacuum cleaner at the end of the day if vacuum cleaner is in working condition or during batch-to-batch change over or during the product-to-product change over which ever is earlier and record in Annexure-I.
5.4 OPERATION OF VACUUM CLEANER:
5.4.1 Ensure the cleanliness of the vacuum cleaner.
5.4.2 Bring the vacuum cleaner for the site of work, where cleaning is necessary.
5.4.3 Fix the three-pin plug to the socket of main electric supply.
5.4.4 Switch “ON” the mains from electrical panel.
5.4.5 Place the open mouth of the nozzle at the point from where dust is to be sucked. Start the vacuum cleaner.
5.4.6 After the dust is removed, stop the vacuum cleaner.
5.4.7 Switch “OFF” the mains and disengage the three-pin plug from the socket of main electric supply.
6.0 ABBREVIATION(S):
IPQA: In Process Quality Assurance
SOP : Standard Operating Procedure
7.0 REFERENCE(S):
SOP: Status labeling
SOP: Destruction of materials.
8.0 ANNEXURE(S):
8.1 Annexure- I: Vacuum Cleaner Cleaning Record
9.0 DISTRIBUTION:
9.1 Master Copy : Quality Assurance
9.2 Controlled Copy (S): Production Department, Quality Assurance, P & A.
9.3 Reference Copy (S) : Production department (10)
ANNEXURE I
VACUUM CLEANER CLEANING RECORD