Hazardous Substances

Handling of Pharma Hazardous and Flammable Solvents & Material in a Pharma Facility

Pharmaceutical products often involve the use of hazardous drugs and flammable solvents that pose risks to the health and safety of workers, patients, and the environment. Therefore, it is essential to follow proper procedures and guidelines for handling these materials in a pharma facility.

What are Hazardous Drugs and Flammable Solvents:

Hazardous drugs are those that have one or more of the following characteristics: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity, or genotoxicity. Examples of hazardous drugs include antineoplastic agents, hormones, immunosuppressants, and some antibiotics.

Flammable solvents are those that have a flash point below 100°F (37.8°C) and can ignite easily when exposed to a source of ignition. Examples of flammable solvents include acetone, ethanol, methanol, and ether.

What are the Risks of Handling Hazardous Drugs and Flammable Solvents?

Handling hazardous drugs and flammable solvents can expose workers to various health hazards, such as:

• Skin irritation, burns, rashes, or allergic reactions

• Eye irritation, damage, or blindness

• Inhalation of toxic vapors, fumes, or dust

• Ingestion of contaminated food or water

• Injection or puncture by needles or sharp objects

• Absorption through the skin or mucous membranes

• Cancer, infertility, birth defects, or genetic mutations

Handling hazardous drugs and flammable solvents can also pose fire and explosion hazards, such as:

• Ignition of flammable vapors by sparks, flames, or static electricity

• Spillage or leakage of flammable liquids or gases

• Accumulation of flammable vapors in confined spaces

• Mixing of incompatible chemicals or solvents

• Generation of heat or pressure by chemical reactions

What are the International Standards and Guidelines for Handling Hazardous Drugs and Flammable Solvents

There are several international standards and guidelines that provide recommendations for handling hazardous drugs and flammable solvents in a pharma facility. Some of the most relevant ones are:

• USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings1: This document describes requirements for personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.

• WHO Good Practices for Pharmaceutical Quality Control Laboratories2: This document provides guidance on the organization, management, personnel, equipment, facilities, documentation, quality assurance, safety, sampling, testing, validation, outsourcing, complaints, recalls, and audits of pharmaceutical quality control laboratories.

• ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients3: This document provides guidance on good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.

Best Practices for Handling Hazardous Drugs and Flammable Solvents

In addition to following the international standards and guidelines mentioned above, some of the best practices for handling hazardous drugs and flammable solvents in a pharma facility are:

• Conducting a risk assessment to identify the hazards and control measures for each process involving hazardous drugs or flammable solvents

• Implementing engineering controls such as closed-system transfer devices, ventilated cabinets, needleless systems, explosion-proof equipment, grounding and bonding devices, fire extinguishers, sprinklers, alarms, and emergency exits

• Using work practices such as proper handling, storage, disposal, labeling, segregation, and transportation of hazardous drugs or flammable solvents

• Providing training and education to workers on the risks and precautions of hazardous drugs or flammable solvents

• Wearing personal protective equipment (PPE) such as gloves, gowns, masks, respirators, eye protection, and shoes

• Cleaning up spills quickly and safely using absorbent materials, neutralizing agents, and spill kits

• Monitoring and evaluating worker exposure and health outcomes using biological monitoring, medical surveillance, and incident reporting

By following these best practices, workers can handle hazardous drugs and flammable solvents in a pharma facility safely and efficiency. You should label Container of hazardous Materials and substances and paste Mark type of solvents and handling Material. Never ignore .