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SOP for Tablet Deduster

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SOP for Tablet Deduster

Operation and Maintenance of Tablet Deduster

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet deduster to ensure efficient removal of dust and particles from tablets.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the tablet deduster 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 tablet deduster.

4) Procedure

4.1 Preparation

  1. Ensure the work area and equipment are clean and sanitized before starting the dedusting process.
  2. Verify the availability and integrity of tablets ready for dedusting.
  3. Inspect the tablet deduster, including dedusting brushes and vacuum systems, to ensure they are clean and operational.
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4.2 Dedusting Process

  1. Set up the dedusting parameters such as brush speed, air flow rate, and dedusting time according to product specifications.
  2. Feed the tablets into the deduster and start the dedusting process.
  3. Monitor the dedusting process to ensure thorough removal of dust and particles from tablets.

4.3 Cleaning and Maintenance

  1. Stop the tablet deduster after completing the dedusting batch.
  2. Clean the dedusting brushes, vacuum systems, and dedusting chamber thoroughly to remove any dust or residue.
  3. Perform routine maintenance tasks such as replacement
of dedusting brushes and inspection of vacuum filters.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet deduster

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

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