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SOP for Ring Extruder

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SOP for Ring Extruder

Operation and Maintenance of Ring Extruder

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring extruder to ensure proper extrusion of rings during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

  1. Ensure the ring extruder is clean and calibrated before use.
  2. Verify the availability of raw materials ready for extrusion.
  3. Inspect the extruder, including dies and heating systems, to ensure they are clean and in good working condition.
See also  SOP for Suppository Packaging Conveyor

4.2 Extrusion Process

  1. Set the extrusion parameters (e.g., temperature, pressure) based on batch specifications.
  2. Feed the raw material into the extruder and start the extrusion process.
  3. Monitor the extruded rings for size, shape, and consistency.

4.3 Cleaning and Maintenance

  1. After completing the extrusion process, clean the extruder thoroughly using approved cleaning agents and procedures.
  2. Inspect and replace worn-out parts as per maintenance schedule.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring extruder specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring extruder

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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