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SOP for Cream Manufacturing Vessel

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SOP for Cream Manufacturing Vessel

Operation and Maintenance of Cream Manufacturing Vessel

1) Purpose

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

2) Scope

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

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4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the cream manufacturing process.
  2. Verify the availability and integrity of cream ingredients ready for manufacturing.
  3. Inspect the cream manufacturing vessel, including mixing elements and temperature controls, to ensure they are clean and calibrated.

4.2 Manufacturing Process

  1. Set up the manufacturing parameters such as temperature, mixing speed, and batch size according to cream formulation specifications.
  2. Load the cream ingredients into the manufacturing vessel according to the batch recipe.
  3. Start the mixing process and monitor to achieve homogeneous mixing and heating of cream.

4.3 Cleaning and Maintenance

  1. Stop the manufacturing vessel after completing the batch.
  2. Empty the vessel and clean all surfaces, including mixing elements and internal walls, to remove
any residues.
  • Perform preventive maintenance tasks such as checking seals, inspecting agitators, and calibrating temperature sensors.
  • 5) Abbreviations, if any

    N/A

    6) Documents, if any

    Batch production record, Cleaning log, Cream manufacturing vessel specifications

    7) Reference, if any

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

    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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