Chemotherapy Cleanroom

USP 800 Gowning – Chemotherapy Gloves, Gowns

USP 800 Hazardous Garments

Appropriate PPE must be worn when handling HDs including during:

  • Receipt
  • Storage
  • Transport
  • Compounding (sterile and nonsterile)
  • Administration
  • Deactivation/decontamination, cleaning, and disinfecting
  • Spill control
  • Waste disposal

Summarized Requirements for USP 800 Gowning [source]

  • Compounding of chemotherapy or hazardous drugs require chemotherapy gowns and chemotherapy rated gloves.
  • Chemotherapy gloves are to be powder free, changed every 30 minutes, and thoroughly inspected before each use
  • Gowns must be disposed after use, close in back, have no front opening, and have closed cuffs that are elastic or knit.
  • Gowns should be replaced as required by governing body, after splashes and every 2 – 3 hours.
  • An additional pair of shoe covers is required when entering secondary areas into HD handling areas
  • Gloves must extend over the cuff of the gown and meet standards for the American Society for Testing and Materials (ASTM) Standard D6978 or later

When Are Chemotherapy Gloves Required?

Handling of all hazardous drugs (HDs), including non antineoplastics, and any HD with reproductive risks requires chemotherapy gloves. The standard for chemotherapy gloves is defined under the American Society for Testing and Materials (ASTM) standard D6978.

Chemotherapy Glove Requirements

  1. Always powder free.
  2. High integrity, no pin holes.
  3. Meets ASTM Standard D6978
  4. Double gloving determined by CSP risk factors

Chemotherapy Glove Standards

  1. Must be inspected for physical defects before use
  2. Sterile HD compounding requires sterile chemotherapy gloves
  3. Change gloves at least every 30 minutes or by manufacturers recommendation
  4. Changed after any tears, punctures, or contamination.

Gowns for Hazardous Drugs and Chemicals

Gowns for HD handling require chemical resistance and non-permeability after HD exposure. Permeability tests and standards are covered by ASTM F739-12. All gown manufacturers should provide results of ASTM F739-12 for certification and validation purposes.

Solution: One of our most commonly suggested hazardous compounding gowns is the Kimtech A7. Its liquid barrier is certified for compatibility with USP 800 hazardous compounding.

One of our most commonly suggested hazardous compounding gowns is the Kimtech A7. Its liquid barrier is certified for compatibility with USP 800 hazardous compounding.

Kimtech™ Certified Liquid Barrier Gown, Blue

Proper Procedure for Liquid Barrier Gowning and Removal

Not all cleanroom garments are made equal. One reason that many facilities favor Kimberly Clark garments is because they provide some unique features which make donning and gowning more simple. For example, color markings on garments help the operator remove the packaging from the garment with fewer variables, and reduce the risk of the operator transferring contamination. 

“The material offers enhanced liquid barrier protection- fabric tested for blood and blood-borne pathogen penetration, chemotherapy drug and hormone permeation (passes ASTM F1670 for penetration of blood and body fluids and ASTM F1671 for blood borne pathogens) and the built-in thumb loops help maintain glove and garment interface. The gowns are low lint to minimize contamination.”

Disposable sleeve covers may be used to protect areas of the arm that may come in contact with HDs. Disposable sleeve covers made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of undercoated materials.

The proper cleanroom gowning room design, gowning supplies and equipment are an essential component of cleanroom contamination control. This informational guide should never take precedence over consulting with a cleanroom contamination specialist who is familiar with your specific equipment and classification needs. For help with cleanroom construction, gowning selection, or furniture purchases, our controlled environment specialists are available for a zero-cost consultation by phone or email.

USP <800> Certified Gowns

Overview of the Kimtech A7

  1. Thumb loops maintain glove and garment interface; preferred among compounding pharmacists.
  2. Seamless front and closed back; Easy to don and doff design
  3. Enhanced liquid barrier protection- fabric tested for blood and blood-borne pathogen penetration, chemotherapy drug and hormone permeation (passes ASTM F1670 for penetration of blood and body fluids) to help protect people and processes from liquid splashes
Kimtech™ Certified Liquid Barrier Gown, Blue

Share this Article:

Facebook
Twitter
LinkedIn
Reddit
Email
Print
Mitch Walleser

Mitch Walleser

Mitch is a contributing writer for Production Automation Corporation. PAC is a factory-direct distributor of products and environmental solutions for industrial and critical requirements within electronics, medical device, life science, pharmaceutical, and general manufacturing industries. Mitch has worked with manufacturing engineers, in-house specialists, and factory experts to highlight and uncover manufacturing solutions. His background includes 3D printing, electronics, and cleanroom manufacturing.

Leave a Reply

Search Posts

About Production Automation

Production Automation Corporation (that’s us) is an essential business supplier for medical device, cleanroom, and general manufacturing industries.

All products featured on the PAC blog are available through the www.gotopac.com webstore. Online orders are shipped and fulfilled Monday – Friday from PAC warehouses in California, Minnesota, and Texas.

Production Automation Corporation (PAC) stands 100% behind a product catalog of over 40,000 products, which includes support for factory warranties, value added services, and returns. Get help from a PAC sales rep during business hours via email, phone, or live chat.

Shop Online: www.gotopac.com
Toll Free: (888) 903-0333
Email: [email protected]
Office Hours: 8am - 5pm CST