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SOP for Handling and Disposal of Waste in MDI Production

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SOP for Handling and Disposal of Waste in MDI Production

Waste Handling and Disposal Procedures for MDI Production

1) Purpose

The purpose of this SOP is to outline the procedures for the proper handling and disposal of waste generated during the production of metered-dose inhalers (MDIs) to ensure environmental protection, safety, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the handling, segregation, storage, and disposal of waste generated at the MDI production facility, including production operators, waste management personnel, and environmental health and safety (EHS) staff.

3) Responsibilities

The responsibilities for this SOP include segregating waste types, ensuring proper storage and labeling, coordinating waste disposal, and maintaining documentation. Specific roles include:
Production Operators: Segregate waste at the point of generation.
Waste Management Personnel: Handle and store waste according to regulatory requirements.
EHS Staff: Oversee waste management practices and ensure compliance with environmental regulations.

See also  SOP for Energy Control Procedures in MDI Production

4) Procedure

4.1 Waste Segregation
4.1.1 Segregate waste into categories such as hazardous, non-hazardous, recyclable, and biohazardous.
4.1.2 Use designated waste containers and bins for different waste types.
4.2 Storage of Waste
4.2.1 Store waste in appropriate containers that are labeled with the type of waste and

accumulation start date.
4.2.2 Ensure waste storage areas are secure, well-ventilated, and inaccessible to unauthorized personnel.
4.3 Waste Disposal
4.3.1 Coordinate waste disposal with authorized waste management vendors or services.
4.3.2 Follow disposal procedures as per regulatory requirements and waste management contracts.
4.4 Spill and Emergency Response
4.4.1 Implement spill response procedures in case of accidental release of hazardous waste.
4.4.2 Maintain spill kits and emergency contacts for quick response.
4.5 Documentation and Recordkeeping
4.5.1 Maintain records of waste generation, segregation, storage, and disposal.
4.5.2 Document waste manifests, disposal certificates, and any incidents related to waste management.

See also  SOP for Training Personnel in MDI Production

5) Abbreviations, if any

MDI: Metered-Dose Inhaler
EHS: Environmental Health and Safety

6) Documents, if any

Waste management plan, waste disposal manifests, spill response procedures, and training records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the EPA, OSHA, and local environmental agencies for waste management regulations.

8) SOP Version

Version 1.0

Metered-Dose Inhaler Tags:Analytical Method Development MDIs, Batch Manufacturing Record MDI, Calibration MDI Equipment, Cleaning Equipment MDIs, Color Consistency Testing MDI, Contamination Prevention MDI, Documentation MDI Manufacturing, Final Product Inspection MDI, Formulation Development MDI, In-process Testing Inhalers, Inhaler Manufacturing Procedures, Inhaler Quality Control SOP, Labeling MDI SOP, MDI Production SOPs, MDI Storage Conditions, Metered-Dose Inhaler SOP, Microbial Testing Inhalers, Packaging of MDIs Procedure, Particle Size Analysis MDIs, Preservative Efficacy MDIs, Process Optimization MDIs, Process Validation MDIs, Propellant Testing MDIs, Quality Testing MDIs, Raw Material Inspection MDIs, Solvents Use in MDI Production, Stability Testing MDIs, Sterility Maintenance MDI, Training Personnel MDI Production, Waste Disposal MDI Production

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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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