by OBJECTIVE
To describe the procedures for cleaning of medicament storage tank.
2.0 SCOPE
This SOP is applicable for procedure for cleaning of medicament storage tank.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
5.0 PROCEDURE
5.1 Check “TO BE CLEANED” label on medicament storage tank as per SOP.
5.3 Ensure that the medicament storage tank is completely empty.
5.4 Bring the storage tank in to the cleaning area and dismantle the medicament storage tank And Fill the storage tank with hot water for 30 minutes. And continue scrub with nylon brush after drain water.
5.5 Take the teepol solution 2% for mopping as inner & outer surface.
5.6 Open the bottom drain valve to drain out water.
5.7 Fill the storage tank with tab water and stir for 5 minutes then after drain the water.
5.8 Check the storage tank for traces of medicament pest. If no traces found.
5.9 Final rinse the Storage tank with purified water.
- Remove
the drain valve check the cleanness of the valve. If required clean it using
hot water.
- Clean the outer surface of storage tank with wet cloth.
5.12 Scrub parts of the holding tank and lid with nylon brush and mop with clean lint free cloth take most care while cleaning the ‘Hard to clean area’ i.e. joints, corners, pipe bents etc.
- Intimate Quality Assurance (Q.A.) for taking wash out sample.
- Finally mopping inner surface with lint free cloth.
- Upon getting clearance for wash out report and take out the parts by wearing gloves and cover it with cling film and affix the label “CLEANED” on the medicament storage tank as per SOP titled SOP/QA/038-01 and keep them in equipment hold area or take back to the Medicament preparation area as and when required.
- Intimate to Q.A. for line clearance of medicament storage tanks.
- After release from Q. A. affix “READY FOR USE” label on the medicament storage tank as per SOP.
- If there is no planning of production for a longer time, rinse the medicament storage tank with Purified water before starting the operation.
5.23 Before using, mop with 70% IPA solution.
6.0 TRAINING
Trainer : Head Production
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. |
