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SOP for Cream Heating System

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SOP for Cream Heating System

Operation and Maintenance of Cream Heating System

1) Purpose

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

2) Scope

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

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the heating process.
  2. Verify the availability and integrity of cream formulations ready for heating.
  3. Inspect the cream heating system, including heating vessels and temperature controls, to ensure they are clean and in good working order.
See also  Vaginal Dosage Forms: SOP for Cream Dispensing Pump

4.2 Heating Process

  1. Set the desired temperature and heating time on the control panel of the heating system.
  2. Transfer the cream formulation into the heating vessel and start the heating process.
  3. Monitor the temperature closely to ensure the cream formulation reaches and maintains the specified heating temperature.

4.3 Cleaning and Maintenance

  1. Stop the heating process after completing the heating cycle.
  2. Allow the heating vessel to cool down sufficiently before cleaning.
  3. Clean the heating vessel and associated
piping thoroughly to remove any residue or contaminants.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cream heating system specifications

7) Reference, if any

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

8) SOP Version

Version 1.0

See also  SOP for Storage Conditions of Raw Materials
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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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