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Vaginal Dosage Forms: SOP for Cream Cooling System

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SOP for Cream Cooling System

Operation and Maintenance of Cream Cooling System

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream cooling system to ensure efficient cooling of cream formulations.

2) Scope

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

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the cooling process.
  2. Verify the availability and integrity of cream formulations ready for cooling.
  3. Inspect the cream cooling system, including cooling tanks and circulation pumps, to ensure they are clean and operational.
See also  SOP for Ring Extruder

4.2 Cooling Process

  1. Set up the cooling parameters such as temperature, agitation speed, and cooling time according to product specifications.
  2. Transfer the cream formulation into the cooling tanks and start the cooling process.
  3. Monitor the temperature and viscosity of the cream during the cooling process to ensure proper cooling.

4.3 Cleaning and Maintenance

  1. Stop the cream cooling system after completing the cooling cycle.
  2. Drain and clean the cooling tanks and circulation lines thoroughly to remove any residual cream.
  3. Perform
routine maintenance tasks such as inspection of cooling coils and lubrication of pumps.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cream formulation specification

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for cream cooling system

8) SOP Version

Version 1.0

See also  SOP for Gel Filling 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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