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SOP for Cream Emulsion Tank

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SOP for Cream Emulsion Tank

Operation and Maintenance of Cream Emulsion Tank

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream emulsion tank to ensure proper emulsification of cream formulations.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the cream emulsion tank 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 cream emulsion tank.

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the emulsification process.
  2. Verify the availability and integrity of cream formulations ready for emulsification.
  3. Inspect the cream emulsion tank, including agitators and temperature controls, to ensure they are clean and operational.
See also  SOP for Cream Homogenization Tank

4.2 Emulsification Process

  1. Set up the emulsification parameters such as mixing speed, temperature, and emulsifying agents according to product specifications.
  2. Load the cream ingredients into the emulsion tank and start the emulsification process.
  3. Monitor the emulsification process to ensure thorough mixing and stabilization of the cream emulsion.

4.3 Cleaning and Maintenance

  1. Stop the cream emulsion tank after completing the emulsification batch.
  2. Flush the tank with appropriate cleaning solutions to remove any residues.
  3. Perform routine maintenance tasks such as inspection of
agitator blades and calibration of temperature sensors.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cream formulation specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for cream emulsion tank

8) SOP Version

Version 1.0

See also  SOP for Tablet Crushing Machine
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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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