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SOP for Gel Packaging Machine

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SOP for Gel Packaging Machine

Operation and Maintenance of Gel Packaging Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel packaging machine to ensure efficient and accurate packaging of gel formulations.

2) Scope

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

See also  SOP for Tablet Polishing Machine

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the packaging process.
  2. Verify the availability and integrity of gel formulations and packaging materials ready for packaging.
  3. Inspect the gel packaging machine, including conveyor belts and sealing units, to ensure they are clean and operational.

4.2 Packaging Process

  1. Set up the packaging parameters such as packaging material type, seal integrity test, and labeling requirements according to product specifications.
  2. Load the gel containers or sachets into the packaging machine and start the packaging process.
  3. Monitor the packaging process to ensure proper filling, sealing, and labeling of gel packages.
See also  SOP for Validation Protocols (IQ, OQ, PQ)

4.3 Cleaning and Maintenance

  1. Stop the gel packaging machine after completing the packaging batch.
  2. Clean the conveyor belts, sealing units, and
packaging area thoroughly to remove any packaging material residues.
  • Perform routine maintenance tasks such as lubrication of moving parts and inspection of sensors.
  • 5) Abbreviations, if any

    N/A

    6) Documents, if any

    Batch production record, Cleaning log, Gel formulation specification

    7) Reference, if any

    GMP guidelines, Manufacturer’s operating manual for gel packaging 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

    • 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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