by OBJECTIVE
To lay down a Procedure for Handling of Encapsulation Dies and Segment.
2.0 SCOPE
This SOP is applicable for Handling of Encapsulation Dies and Segment.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY:
QA & Head Production : For system compliance
5.0 PROCEDURE:
5.1 ISSUANCE USES, CLEANING AND RETRIEVAL:
5.1.1 Officer / Executive Production shall prepare the list of Dies & Segment “List of Dies and Segment”.
5.1.2 When Dies & Segment are required, Officer / Executive Production shall issue the number of
Dies to the concerned operator and make entry in Dies Utilization Record
“Die and Segment Utilization Record”.
5.1.3 Operator shall check the condition of left and right Dies and enter the details
Die and Segment Utilization Record”.
5.1.4 Transfer the Dies & Segment to respective Encapsulation area by trolley.
5.1.5 Set up and fix Dies & Segment on the machine as per specified in respective BPCR.
5.1.6 Remove the Dies & Segment after encapsulation.
5.1.7 After removing dies from the machine clean with 2% teepol and mop with 70% Isopropyl alcohol using
dry Lint free cloth.
5.1.8 Check visually for damage of dies occurred during handling, if any damages are there inform Immediately to Officer / Executive Production and make necessary entry in the Dies Utilization Record and sign and put STATUS LABEL as “REJECTED DIES DO NOT USE” the damaged Dies in separate box and send to engineering department for destruction.
5.1.9 Investigate the cause of damages to the Dies and make necessary action plan to avoid in future as per current version “Incident Reporting System”.
5.1.10 Smear the good Dies & Segment with light liquid paraffin and put into the box.
5.1.11 Transfer the Dies & Segment to the respective SS cabinet by trolley, lock the cabinet and make Entry in Dies Utilization Record.
5.2 DESTRUCTION OF DIES:
5.2.1 Visually inspect the Dies & Segment after receiving from the machine.
5.2.2 After inspection of Dies & Segment if Dies & Segment are not meeting to its standard, send to
Engineering department for destruction.
5.2.3 After receiving damaged Dies from production, engineering department has to be defaced the Dies on grinding machine and record. “Destruction Record of Dies and Segment”.
6.3 CLEANING PROCEDURE:
6.3.1 Take the Change Part (Die & Segment) to the washing area and rub the inner surface using nylon brush
6.3.2 Wash the Die & Segment using 2 % v/v Teepol solution with hot water using nylon brush.
6.3.3 Clean the potable water and finally rinse with purified water.
6.3.4 Again rinse the purified water and examine the water visually for any turbidity.
6.3.5 If there is no any turbidity, Officer/Executive QA shall collect the rinse sample with intimation slip cum analysis report and send to QC for analysis.
6.3.6 Take the cleaned Die & Segment vessel to production area.
6.3.7 Mop the Die & Segment with 70% IPA solution.
6.3.8 Affix a status label as “Cleaned”.
6.3.9 Enter the cleaning details in “Machine Utilization Record”.
6.0 TRAINING
Trainer : Head – Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
8.0 ATTACHMENTS
| ANNEXURES NO. | TITLE OF ANNEXURE | FORMAT NO. |
| Annexure-I | NA | NA |
- 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. |
