Operation of Vacuum Transfer System (VTS)

In this post Standard Operating Procedure of Operation of Vacuum Transfer System (VTS) in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for Operation of Vacuum Transfer System.

2.0 SCOPE:

This SOP is applicable to the Operation of Vacuum Transfer System in granulation area.

3.0 RESPONSIBILITY:

Production: Technical Associate/ Officer /Executive/Assistant Manager.

Head Production: To ensure execution & compliance.

Head QA: To ensure the compliance.

4.0 PROCEDURE:

4.1 OPERATION:

4.1.1 Machine Setting

4.1.1.1 Ensure that the equipment is cleaned and ready for use.

4.1.1.2 Ensure that the Emergency is in closed condition.

4.1.1.3 Assemble suction air filter and lid of filter housing chamber and tighten the eye bolt rotating in clockwise direction.

4.1.1.4 Connect suction inlet valve and purging assembly with VTS by tightening the TC clamp and also connect hose pipe with the suction outlet port.

4.2.2 Operation

4.2.2.1 Operation of VTS for Co-mill

4.2.2.1.1 After line clearance from QA, put the “UNDER PROCESS” label on the machine.

4.2.2.1.2 Enter the start time in equipment sequential log book as per SOP.

4.2.2.1.3 Use hand gloves and nose mask during the process.

4.2.2.1.4 Connect hose pipe fitted with VTS at one end of previously cleaned IPC/BIN and also connect a hose pipe with another end of above IPC/BIN to the discharge port of the Co-mill and connect another hose pipe with feeding port of Co-mill to material to be transferred from

FBD bowl.

4.2.2.1.5 Release the emergency and start the VTS and feed the material from FBD bowl into Co-mill and collect the milled material into the IPC/BIN through suction. Ensure that the VTS filter purging is working properly throughout the process.

4.2.2.1.6 Stop the VTS after completion of operation.

4.2.2.1.7 Enter the completion time in equipment sequential log book as per SOP.

4.2.2.1.8 Remove the “UNDER PROCESS” label and affix “TO BE CLEANED” label on the machine

4.2.2.2 Operation of VTS for Octagonal blender (3000 litre)

4.2.2.2.1 After line clearance from QA, put the “UNDER PROCESS” label on the machine.

4.2.2.2.2 Enter the start time in equipment sequential log book as per SOP.

4.2.2.2.3 Use hand gloves and nose mask during the process.

4.2.2.2.4 Connect hose pipe connected with VTS to one port of Octagonal blender and connect another hose pipe with another port of blender to the material to be transferred from IPC.

4.2.2.2.5 Release the emergency and switch ON the VTS and charge the material from IPC into the octagonal blender through suction.

4.2.2.2.6 Stop the VTS after completion of charging.

4.2.2.2.7 Enter the completion time in equipment sequential log book as per SOP.

4.2.2.2.8 Remove the “UNDER PROCESS” label and affix “TO BE CLEANED” label on the machine.

5.0 ANNEXURE (S):

Nil

6.0 REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating Procedure (SOP).

SOP: Procedure for area line clearance.

7.0 ABBREVIATION (S) / DEFINITION (S):

SOP : Standard Operating Procedure

BMR : Batch Manufacturing Record