by OBJECTIVE
To lay down a Procedure for Cleaning of Medicament Vessel
2.0 SCOPE
This SOP is applicable for Cleaning of Medicament Vessel used in production area
3.0 RESPONSIBILITY
Production Chemist & Operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
5.0 PROCEDURE:
5.1 CLEANING
5.1.1 Switch “OFF” the button and disconnect of the wire of medicament mixing assembly
5.1.2 Remove “TO BE CLEANED” label from the equipment.
5.1.3 Dismantle the parts of the equipment and transfer to washing area for cleaning.
5.1.4 Top dome (clean in place)
Mop the inner and outer surface of top dome with lint free duster soaked in purified water and to remove adhered material Repeat this activity. Finally dry mop inner and outer surface of the top dome with dry lint free duster.
5.1.5 Vacuum pump line
Flush the vacuum pump line (dismantled) with purified water and rinse with purified water
5.1.6 Vacuum break air filter
Flush the vacuum break air filter with purified water and rinse with purified water
5.1.7 Circular gasket
Flush the circular gasket with purified water followed by scrubbing with nylon scrubber using 2 % teepol solution /liquid soap. Again flush with purified water and followed by scrubbing with purified water. Flush with purified water and finally rinse with warm purified water Intimate to QA for wash water sampling and send wash water to QC department for analysis.
5.1.8 Clean the outer body of mixing assembly with lint free cloth dipped in purified water and mop with 70% IPA.
5.1.9 Washing parameters for dismantled parts:
5.1.10 Assembling: Assemble the Top dome, Circular gasket, Vacuum pump line, Vacuum break air filter, stirrer and bowl, and intimate to QA person to Wash Water sampling after sampling send to QC department for analysis and getting clearance for cleanliness from IPQA Executive.
5.1.11 Affix the label “CLEANED” on medicament mixing assembly by sign of production executive and verified by IPQA
5.1.12 Cleaning record entries in respective equipment log book
6.0 TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of the production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
8.0 ATTACHMENTS
Nil
- REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
