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SOP for Gel Filling and Sealing Machine

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SOP for Gel Filling and Sealing Machine

Operation and Maintenance of Gel Filling and Sealing Machine

1) Purpose

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

2) Scope

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

See also  SOP for Stability Storage Conditions

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the filling and sealing process.
  2. Verify the availability and integrity of gel formulations ready for filling.
  3. Inspect the gel filling and sealing machine, including filling nozzles and sealing mechanisms, to ensure they are clean and properly set up.

4.2 Filling and Sealing Process

  1. Set up the filling parameters such as fill volume, speed, and container specifications according to product specifications.
  2. Load the gel containers onto the machine conveyor and start the filling and sealing process.
  3. Monitor the filling and sealing process to ensure accurate filling and proper sealing of gel containers.
See also  SOP for Batch Record Review and Approval

4.3 Cleaning and

Maintenance

  1. Stop the gel filling and sealing machine after completing the filling and sealing batch.
  2. Clean the filling nozzles, sealing heads, and conveyor belts thoroughly to remove any gel residues.
  3. Perform routine maintenance tasks such as lubrication of sealing mechanisms and inspection of conveyor belt tension.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel formulation specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel filling and sealing machine

8) SOP Version

Version 1.0

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Next Post: SOP for Pharmacovigilance Development Safety Update Reports (DSUR)

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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