Standard Operating Procedure for Handling and Disposal of Waste Materials from Form-Fill-Seal (FFS) Machine

1) Purpose

The purpose of this SOP is to establish procedures for the safe handling, segregation, and disposal of waste materials generated from the Form-Fill-Seal (FFS) machine operations to ensure environmental protection and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in waste management and disposal activities within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Operators

• Segregate waste materials according to waste management plan.
• Ensure proper labeling and handling of waste containers.

3.2 Environmental Health and Safety (EHS) Team

• Monitor waste handling procedures for compliance with regulations.
• Coordinate waste disposal with authorized waste management providers.

4) Procedure

4.1 Waste Segregation

1. Separate different types of waste (e.g., general, hazardous).
2. Use designated waste containers and labels as per waste segregation guidelines.

4.2 Storage and Collection

1. Store waste containers in designated storage areas.
2. Schedule regular collection and disposal with authorized waste management vendors.

4.3 Waste Disposal

1. Coordinate waste pickup and transportation to approved disposal facilities.
2. Ensure compliance with local and federal regulations for waste disposal.

4.4 Documentation and Record Keeping

1. Maintain records of waste generation, handling, and disposal activities.
2. Document waste disposal certificates and manifests.

5) Abbreviations, if any

SOP: Standard Operating Procedure; EHS: Environmental Health and Safety; FFS: Form-Fill-Seal

6) Documents, if any

• Waste Management Plan
• Waste Disposal Certificates
• Waste Handling Logs

7) Reference, if any

EPA Regulations: Resource Conservation and Recovery Act (RCRA)
OSHA 29 CFR 1910.120: Hazardous Waste Operations and Emergency Response

8) SOP Version

Version 1.0