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SOP for Ventilation and Environmental Controls in Nanoparticle Production Areas

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SOP for Ventilation and Environmental Controls in Nanoparticle Production Areas

Standard Operating Procedure for Ventilation and Environmental Controls in Nanoparticle Production Areas

1) Purpose

This SOP outlines the necessary ventilation and environmental controls in areas where nanoparticles are produced to minimize airborne nanoparticle exposure and ensure safe working conditions.

2) Scope

This SOP applies to all nanoparticle production, research, and quality control environments where airborne particles could pose a risk to workers.

3) Responsibilities

  • Facility Manager: Responsible for maintaining ventilation systems and ensuring proper environmental controls in production areas.
  • Operators: Must adhere to safety protocols related to ventilation and containment.
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4) Procedure

4.1 Ventilation Controls

4.1.1 Local Exhaust Ventilation

  • 4.1.1.1 Use local exhaust ventilation (LEV), such as fume hoods or downdraft benches, to capture nanoparticles at the source during production.

4.1.2 HEPA Filtration

  • 4.1.2.1 Ensure that ventilation systems are equipped with HEPA filters to trap airborne nanoparticles before releasing air back into the workspace.

4.2 Environmental Monitoring

4.2.1 Air Quality Monitoring

  • 4.2.1.1 Regularly monitor the air quality in nanoparticle production areas to detect any buildup of airborne nanoparticles and adjust ventilation settings as needed.

4.3 Containment and Isolation

4.3.1 Containment Zones

  • 4.3.1.1 Use containment barriers or enclosures for high-risk nanoparticle production processes to prevent the spread of nanoparticles beyond the work area.
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4.4 Maintenance of Ventilation Systems

4.4.1 Regular Maintenance

  • 4.4.1.1 Schedule regular
maintenance of ventilation and filtration systems to ensure they are functioning properly and replace filters as needed.

5) Abbreviations, if any

  • LEV: Local Exhaust Ventilation
  • HEPA: High-Efficiency Particulate Air

6) Documents, if any

  • Ventilation System Maintenance Logbook

7) References, if any

  • Guidelines for air quality control in nanoparticle production environments

8) SOP Version

Version 1.0

Annexure

Ventilation System Maintenance Logbook Template

Date System Maintained Maintenance Performed Filter Replacement Operator Initials Supervisor Initials
DD/MM/YYYY System Name Description of Maintenance Yes/No Operator Name Supervisor Name
           
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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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