The objective of this document is to provide the procedure for capsule drying and cleaning of drying chamber.
This SOP is applicable for capsule drying and cleaning procedure of drying chamber.
Production Chemist & Operator : To follow the procedure
QA & Head Production : For system compliance
5.1 CAPSULE DRYING PROCEDURE.
5.1.1 Check and ensure the cleanliness of Drying Chamber.
5.1.2 Check and ensure the environmental condition of drying chamber as per specified in respective batch production and control records.
5.1.3 Transfer the capsules from encapsulation machine through tumbler by compressed air pressure to the chamber.
- Spread the capsules in trays and hold the trays to the trolleys.
5.1.5 Put the tray to the outlet of the tumbler at chamber. Fill the trays and put it in the tray holder trolley with label.
5.1.6 Affix the status label to the each trolley having capsules dully filled and signed by competent staff.
5.1.7 Dry the capsules approximately 30-48 hours or till the desired moisture content as per specified in respective batch production and control records.
5.1.8 Shuffle the capsules within 2 to 3 hours after encapsulation and do shuffling frequently.
5.1.9 Send the intimation to quality assurance for sampling of LOD sample and QA send the LOD sample In QC Department for analysis of moisture content in capsule shell.
5.1.10 After getting approval from quality control department, transfer the capsules for further process.
5.1.11 Record the details in respective log book.
- Clean the drying room floor.
- After cleaning of the floor transfer the trolleys to the inlet again.
Trainer : Head – Production Department
Trainees : Production Chemist, drying operator and QA chemist.
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department (If Required)
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11.0 REVISION HISTORY OF CHANGE
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