STANDARD OPERATING PROCEDURE FOR CAPSULE DRYING AND CLEANING PROCEDURE OF DRYING CHAMBER.

1.   OBJECTIVE

            The objective of this document is to provide the procedure for capsule drying and cleaning            of drying chamber.

• SCOPE

           This SOP is applicable for capsule drying and cleaning procedure of drying chamber.

3.0       RESPONSIBILITY

           Production Chemist & Operator      : To follow the procedure

4.0      ACCOUNTABILTY  

QA & Head Production                  : For system compliance

•       PROCEDURE

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.

5.2   Cleaning:

• Clean the drying room floor.
• After cleaning of the floor transfer the trolleys to the inlet again.

6.0       TRAINING

Trainer   : Head – Production Department

 Trainees : Production Chemist, drying operator and QA chemist.

7.0       DISTRIBUTION

Master Copy                     :           QA Department

Controlled Copy               :           Production Department

Display Copy                    :           Production Department (If Required)

8.0       ATTACHMENTS

Sr. No	Annexure No	Title	Format No.
1	NA	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.