Standard Operating Procedure of Sops For Transfer Of Raw Material In Sterile Area is describe in this post.
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1. PURPOSE
1.1 The purpose of this SOP is to describe the standard procedure for the transfer of Raw Material in the Sterile Manufacturing Area.
2. SCOPE
2.1 The SOP is applicable to the transfer of Raw Material in the Sterile Manufacturing Area of Liquid Injectable Section.
3. RESPONSIBILITY
3.1 Area Supervisor is responsible for conducting the activities as per SOP.
3.2 Production Officer is responsible for checking the activities as per SOP.
3.3 QA Officer is responsible for monitoring the activities as per SOP.
3.4 Production Manager is responsible to ensure implementation of this SOP
4. MATERIALS & EQUIPMENTS
4.1 Raw Material
4.2 IPA (70% Solution)
4.3 Transfer Hatch
5. PROCEDURE
5.1 The materials which are required in sterile area for manufacturing are sent through transfer hatch.
5.2 Before transferring the materials through transfer hatch, mop the material container with IPA 70% solution.
5.3 Transfer the container into transfer hatch using the outside door of hatch and close the door.
5.4 Switch ON the main power supply and press the start button of transfer hatch. Check that air supply and UV light is ON. Now wait for 5minutes.
5.5 Open the hatch from sterile side and take the material into the section for use. Close the door.
5.6 Precautions
5.6.1 Check that the materials are properly sealed while entering into the area.
5.6.2 Do not open both doors of the hatch at the same time.
6. REPORTING
NA
7. REFERENCE DOCUMENTS
7.1 SOP for operation of Transfer Hatch
7.2 SOP for cleaning of Transfer Hatch
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