by - OBJECTIVE:
To lay down a Procedure for Operation and Cleaning of Gelatin Mass Holding Tank.
- SCOPE:
This SOP is applicable to Operation & Cleaning of Gelatin Mass Holding Tank used in Soft Gelatin Capsule Section.
- RESPONSIBILITY:
Officer / Executive Production – Monitor the Operation & Cleaning of Gelatin Mass Holding Tank
- ACCOUNTABILITY:
Head Production – Training and effective implementation of the SOP
| 5.0 | PROCEDURE: Dismantle the SS valve from the tank. | |
| 5.1 | Cleaning | |
| 5.1.1 | Switch “OFF” the button and disconnect plug of gelatin holding tank. | |
| 5.1.2 | Remove “TO BE CLEANED” label from the tank | |
| 5.1.4 | Remove the residual gelatin paste, if any from the tank and transfer to washing area for cleaning. | |
| 5.1.5 | Wash the SS tank with hot purified water and dismantle the SS valve from the tank. | |
| 5.1.6 | Mop and clean the gelatin paste adhered to inner and outer surface of SS tank with nylon brush using purified water with 2% Teepol. Flush excess water to remove any sticked gelatin paste through valve. | |
| 5.1.7 | Finally mop with IPA 70% inner and outer surface of the SS tank with lint free cloth. | |
| 5.1.8 | Send the sample to Quality Control for wash water analysis through In process Quality Assurance. | |
| 5.1.9 | Assembling: Assemble the SS valve and SS tank after getting clearance for cleanliness from IPQA . | |
| 5.1.1 | Affix the label “CLEANED” on SS gelatin holding tank after getting signed by Production chemist and Verified by IPQA | |
| 5.1.1 | Record entries of cleaning in respective log book. | |
| 5.2 | Operation : | |
| 5.2.1 | Before operation ensure concerned person must be in proper over gowning and area should be neat and clean. | |
| 5.2.2 | Check proper fitting of assembled parts with status label. | |
| 5.2.4 | Place the preheated temperature about (60oC±5 oC) gelatin holding tank below the manufacturing tank. | |
| 5.2.5 | Open the valve and collect the gelatin mass in to gelatin holding tank. | |
| 5.2.6 | Transfer the gelatin holding tank to gelatin feeding area and connect its heated connection to the electrical supply point to maintain the temperature at (60oC±5 oC) throughout the encapsulation period. | |
| 5.2.8 | If gelatin mass is not to be used immediately, then hold the gelatin receiver tank in specified gelatin holding area. |
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees : Production Staff, QA & Operator
7.0 DISTRIBUTION
Master Copy : Quality Assurance
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. |
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