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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 in the manufacturing process.

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. Verify the availability of cream batches and batch records.
  2. Inspect the cream cooling system for cleanliness and ensure proper functioning of cooling pipes, temperature controls, and safety features.
  3. Ensure all safety protocols are followed, including monitoring coolant levels.
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4.2 Cooling Process

  1. Set the desired temperature on the cooling system according to cream specifications.
  2. Start the cooling process and monitor the temperature of the cream as it passes through the cooling pipes.
  3. Adjust cooling settings as necessary to maintain optimal cream temperature.

4.3 Cleaning and Maintenance

  1. After completing the cooling process, flush the cooling pipes with clean water or approved cleaning solution.
  2. Inspect and clean cooling filters and components regularly to prevent blockages.
  3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch

production record, Cleaning log, Cream cooling system specifications

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7) Reference, if any

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

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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