Standard Operating Procedure of Operation Of Material Transfer Hatch in Pharmaceuticals is describe in this post.
{getToc} $title={Table of Contents}
1 PURPOSE
1.1 The purpose of this SOP is to describe the standard procedure for the use of materials transfer Hatch.
2 SCOPE
2.1 This SOP is applicable in liquid injectable section.
3 RESPONSIBILITIES & AUTHORITIES:
3.1 Concerned Officer Production
3.2 Supervisor
3.3 Operators
3.4 Workers
4 REFERENCES
NA
5 DEFINITIONS
5.1 List of GMP Definitions
6 PROCEDURE
6.1 Check the cleaning status of the materials transfer hatch.
6.2 Check the materials transfer hatch for proper Function.
6.3 Following materials are transferred through materials transfer hatch:
6.3.1 Raw Materials
6.3.2 Empty capsules
6.3.3 Empty Glass bottles/ampoules/vials/caps/seals/unit cartons/labels/alu-tubes etc.
6.4 Spray the container with IPA and then dry it with lint free cloth.
6.5 De-dust the boxes of packaging materials before shifting from material transfer hatch.
6.6 Switch ON the main power supply of material transfer hatch.
6.7 Open the window and place the material.
6.8 Close the window and switch ON the UV light for 5-10 minutes.
6.9 Open the window from other side and take off the materials.
7 PRECAUTIONS
7.1 In case of electricity failure, switch OFF the Hatch.
7.2 Never open both the windows of hatch at a time.
7.3 Always make sure the locking of hatch windows.
8 REFERENCE AND DOCUMENTS
8.1 Line clearance certificate
8.2 Identification Slip
8.3 Machinery / Equipment cleaning log sheet.
{getButton} $text={Download in Microsoft Office} $icon={Download} $color={Hex Color}