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SOP for Ring Extrusion Die

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SOP for Ring Extrusion Die

Operation and Maintenance of Ring Extrusion Die

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring extrusion die to ensure accurate and consistent production of rings.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the ring extrusion die 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 extrusion die.

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the extrusion process.
  2. Verify the availability and integrity of ring raw materials ready for extrusion.
  3. Inspect the ring extrusion die, including die plates and temperature controls, to ensure they are clean and calibrated.
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4.2 Extrusion Process

  1. Set up the extrusion parameters such as temperature, pressure, and speed according to ring specifications.
  2. Load the ring raw materials into the extrusion machine hopper.
  3. Start the extrusion process and monitor to ensure consistent extrusion of rings.

4.3 Cleaning and Maintenance

  1. Stop the extrusion machine after completing the batch.
  2. Disassemble the extrusion die carefully and clean all parts thoroughly to remove any residues.
  3. Perform preventive maintenance tasks such as inspecting die plates, replacing worn
parts, and lubricating mechanical components.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Extrusion die specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for extrusion die

8) SOP Version

Version 1.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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