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SOP for Cream Filling Machine

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SOP for Cream Filling Machine

Operation and Maintenance of Cream Filling Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the cream filling machine to ensure accurate and efficient filling of cream formulations into containers.

2) Scope

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

See also  SOP for Tablet Compression Tool

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the filling process.
  2. Verify the availability and integrity of containers and cream formulation ready for filling.
  3. Inspect the cream filling machine, including filling nozzles and conveyor systems, to ensure they are clean and operational.

4.2 Filling Process

  1. Set up the filling parameters such as fill volume, fill speed, and container handling according to product specifications.
  2. Load the containers onto the filling line and start the filling process.
  3. Monitor the filling process to ensure accurate filling of cream into containers and proper sealing of containers.
See also  SOP for Ring Forming Tool

4.3 Cleaning and Maintenance

  1. Stop the cream filling machine after completing the filling batch.
  2. Clean the filling nozzles, conveyor systems, and filling
area thoroughly to remove any product residues.
  • Perform routine maintenance tasks such as inspection of seals, lubrication of moving parts, and calibration of fill volume.
  • 5) Abbreviations, if any

    N/A

    6) Documents, if any

    Batch production record, Cleaning log, Cream formulation record

    7) Reference, if any

    GMP guidelines, Manufacturer’s operating manual for cream filling machine

    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

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