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SOP for Gel Manufacturing Vessel

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SOP for Gel Manufacturing Vessel

Operation and Maintenance of Gel Manufacturing Vessel

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel manufacturing vessel to ensure efficient production of gel formulations.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel manufacturing vessel 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 gel manufacturing vessel.

4) Procedure

4.1 Preparation

  1. Verify the availability of raw materials and batch records for gel production.
  2. Inspect the manufacturing vessel for cleanliness and proper functioning of agitators, temperature controls, and other components.
  3. Ensure all safety procedures are followed, including checking emergency stop mechanisms.
See also  SOP for Cream Homogenization Tank

4.2 Gel Manufacturing Process

  1. Set the temperature and agitation speed according to batch specifications.
  2. Add raw materials into the vessel and initiate mixing.
  3. Monitor the gel manufacturing process, adjusting parameters as necessary to maintain quality.

4.3 Cleaning and Maintenance

  1. After completing the manufacturing process, drain the vessel and clean it thoroughly using approved cleaning agents.
  2. Inspect and sanitize all parts of the vessel, including seals and filters.
  3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning

log, Gel manufacturing vessel specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel manufacturing vessel

See also  SOP for Computerized Systems Validation

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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