Cleanroom safety eyewear product illustration by Klaritex
Cleanroom safety eyewear product illustration by Klaritex

The Importance of USP 800 Compliance

In the healthcare and pharmacy industry, protecting workers from hazardous drugs, such as chemotherapy agents, is a top priority. The United States Pharmacopeia (USP) Chapter 800 establishes stringent guidelines for ensuring safety through the use of personal protective equipment (PPE).

Understanding USP 800 Cleanroom Requirements

USP 800 aims to enhance safety measures in facilities handling hazardous drugs. It outlines specific requirements for PPE, which acts as a crucial barrier against contamination and exposure.

Key PPE Requirements:

  • Gloves: Use ASTM-tested, powder-free, double-gloved protection to prevent exposure.
  • Gowns: Wear single-use, disposable gowns made of polyethylene-coated polypropylene for maximum protection.
  • Head, Hair, Shoe, and Sleeve Covers: Utilize waterproof, non-shedding covers to prevent contamination.
  • Eye and Face Protection: Wear goggles and full-face respirators to shield against potential exposure.
  • Respiratory Protection: Use NIOSH-certified N95 masks or activated-charcoal R95 masks for airborne particle and vapor protection.

The Role of PPE in Compounding Pharmacies

Compounding pharmacies must adhere to USP 800 guidelines to ensure employee and customer safety. This includes selecting appropriate cleanroom garments that meet stringent cleanliness and protection standards.

Choosing the Right Cleanroom Apparel

When selecting cleanroom garments, consider:

  • Particle Cleanliness: Ensure garments meet specific particle cleanliness levels.
  • Electrostatic Properties: Choose garments with anti-static properties to prevent particle attraction.
  • Durability and Comfort: Select garments that are durable, comfortable, and allow for easy movement.
  • Chemical Compatibility: Ensure garments are resistant to hazardous drug chemicals.

 

 

By adhering to USP 800 guidelines and selecting appropriate PPE, healthcare facilities can significantly reduce exposure risks. Klaritex offers a wide range of USP 800-compliant cleanroom apparel designed for safety, performance, and reliability.

USP Cleanroom PPE Requirements – Frequently Asked Questions (FAQs)

What PPE is mandatory under USP ?

 Chemically resistant gowns, sealed goggles, double gloves, and respirators.

To prevent exposure to cytotoxic drug splashes.

 Pressure-controlled rooms, HEPA filters, and validated PPE processes.

After spills, contamination events, or per facility SOP.

Incorrect PPE, insufficient airflow, lack of documentation, and poor waste disposal.