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Vaginal Dosage Forms: SOP for Cream Mixing Vessel

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SOP for Cream Mixing Vessel

Operation and Maintenance of Cream Mixing Vessel

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream mixing vessel to ensure thorough mixing of cream formulations.

2) Scope

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

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the mixing process.
  2. Verify the availability and integrity of cream formulations ready for mixing.
  3. Inspect the cream mixing vessel, including agitators and temperature controls, to ensure they are clean and operational.
See also  SOP for Tablet Sorter and Inspector

4.2 Mixing Process

  1. Set up the mixing parameters such as mixing speed, temperature, and duration according to product specifications.
  2. Load the cream ingredients into the mixing vessel and start the mixing process.
  3. Monitor the mixing process to ensure uniform dispersion of ingredients and achieve the desired cream consistency.

4.3 Cleaning and Maintenance

  1. Stop the cream mixing vessel after completing the mixing batch.
  2. Flush the vessel 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 mixing vessel

8) SOP Version

Version 1.0

See also  SOP for Gel Storage Unit
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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

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