by - OBJECTIVE
To lay down the Procedure for bottle packing.
2.0 SCOPE
This SOP is applicable for bottle packing.
3.0 RESPONSIBILITY
Production Chemist & operator : To follow the procedure
4.0 ACCOUNTABILTY
QA & Head Production : For system compliance
- PROCEDURE
- Bottle Filling
- Ensure the bottle filling area should be clean before the start of bottle filling.
- Take the line clearance by IPQA Officer.
- Received the dispensed quantity of bottle after cleaning on the presence of IPQA & Production department.
- Received the capsules from quarantine on the presence of IPQA & Production department.
- Ensure the bottle filling person wear proper Cap, nose mask, gloves & Gowning.
- Count the capsules by capsules counter/Manually and fill in cleaned bottle.
- And put the silica gel in the filled bottle if recommended.
- Bottle Sealing
- After filling of capsules in bottle affix induction seal in bottle cap and closed the bottle cap and seal the bottle through induction sealing machine by pressing the induction heat bottom on filled bottle cap upto 0.5 to 0.8 seconds.
- Labeling of bottle
- After filling and sealing the bottle transfer the bottle in secondary packing department.
- Take the printed label and pest on the bottle manually.
- After labeling of bottle pack in outer carton if recommended.
- After carton packing pest the hologram, Barcode on specific place of carton.
- And finally packed in corrugated box and send into the finished good storage area.
- Maintain the record in respective log book.
- Bottle Filling
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
Nil
- 9.0 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. |
| 1 | NA | New SOP | 00 |
