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SOP for Safe Handling of Nanoparticles and Nanomaterials

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SOP for Safe Handling of Nanoparticles and Nanomaterials

Standard Operating Procedure for Safe Handling of Nanoparticles and Nanomaterials

1) Purpose

This SOP outlines the procedures to safely handle nanoparticles and nanomaterials in the laboratory and manufacturing environments to minimize exposure risks and ensure compliance with safety regulations.

2) Scope

This SOP applies to all personnel working with or around nanoparticles and nanomaterials, including those in research, production, and quality control areas.

3) Responsibilities

  • Operators: Responsible for safely handling nanoparticles and using appropriate PPE as outlined in this SOP.
  • Safety Officer: Monitors the work environment to ensure compliance with safety standards and regulations.
  • QA: Ensures safety protocols are followed during nanoparticle production and handling.
See also  Nanoparticle Formulation : SOP for Use of Cryoprotectants in Nanoparticle Formulations

4) Procedure

4.1 PPE Requirements

4.1.1 Personal Protective Equipment

  • 4.1.1.1 Wear appropriate PPE, including gloves, lab coats, and eye protection, when working with nanoparticles.
  • 4.1.1.2 For processes generating airborne nanoparticles, use respiratory protection or work in a fume hood.

4.2 Safe Handling Techniques

4.2.1 Containment of Nanoparticles

  • 4.2.1.1 Use enclosed processes or containment devices to prevent the release of nanoparticles into the work environment.

4.2.2 Minimizing Exposure

  • 4.2.2.1 Use wet methods when possible to reduce the generation of airborne nanoparticles.

4.3 Clean-Up and Disposal

4.3.1 Cleaning Procedures

  • 4.3.1.1 Use HEPA-filtered vacuums or wet wiping techniques to clean surfaces where nanoparticles are handled.
See also  SOP for Formulation of Protein-Based Nanoparticles

4.3.2 Waste Disposal

  • 4.3.2.1 Dispose of nanoparticle waste in accordance with hazardous waste regulations, labeling all waste containers properly.

5) Abbreviations, if any

  • PPE: Personal Protective Equipment
  • HEPA: High-Efficiency Particulate Air

6) Documents, if any

  • Nanoparticle Handling Logbook

7) References, if any

  • OSHA guidelines for nanoparticle handling

8) SOP Version

Version 1.0

Annexure

Nanoparticle Handling Logbook Template

Date Material Handled Safety Measures Used Waste Disposal Method Operator Initials Safety Officer Initials
DD/MM/YYYY Material Name Safety Measures Used Disposal Method Operator Name Safety Officer 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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