SOP Guide for Pharma

Vaginal Dosage Forms: Vaginal Dosage Forms: SOP for Ring Forming Tool

SOP for Ring Forming Tool

Operation and Maintenance of Ring Forming Tool

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring forming tool to ensure accurate formation of rings during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the ring forming tool in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the ring forming tool.

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the forming process.
  2. Verify the availability and integrity of materials ready for forming rings.
  3. Inspect the ring forming tool, including molds, heating elements, and controls, to ensure they are clean and in good working condition.

4.2 Forming Process

  1. Set up the ring forming tool as per the specifications of the ring design.
  2. Adjust the heating temperature and pressure settings according to the material being used.
  3. Place the material into the forming molds and activate the forming process.

4.3 Cleaning and Maintenance

  1. Stop the forming process after completing the batch.
  2. Allow the forming tool to cool down before disassembling for cleaning.
  3. Clean the forming molds, heating elements, and controls
using approved cleaning agents.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring forming tool specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring forming tool

8) SOP Version

Version 1.0

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