Helping to Ensure Protection Against Infectious Disease Through ASTM Standards

Without a cure for infectious diseases like Ebola, measures to prevent their spread become the best line of defense for healthcare workers and the public at large. The use of optimal safety standards and protocols are critical, and technical standards from ASTM International guide the strength, integrity and potency of the key protective tools available to us today. Recent examples include:

ASTM Safety Standards in Action / 2014
• National Nurses United, the largest union and professional association of registered nurses in the United States, sent a letter to President Obama in October calling for the mandatory use of “full-body hazmat suits that meet the ASTM F1670 standard for blood penetration, the ASTM F1671 standard for viral penetration, and that leave no skin exposed or unprotected.”

• The California Department of Public Health and Cal-OSHA updated its mandates for hospitals to include that workers at risk of exposure to the Ebola virus must be provided full-body personal protective suits that meet the ASTM F1670 and F1671 standards.

• The InterAgency Board for Equipment Standardization and Interoperability (IAB) released a new set of recommendations for hospitals that certain personal protective equipment (PPE) meet ASTM safety standards, including ASTM E96, F1671, F1868 and for garments, ASTM D6319 for gloves and ASTM F1671 for footwear.

• The U.S. Occupational Safety and Health Administration (OSHA) suggests that coveralls should pass ASTM F1670 or F1671 in its fact sheet and PPE selection matrix intended to help employers select appropriate PPE for workers who may be exposed to Ebola.

ASTM F1670 and F1671 - Protective Clothing Safety
 “Protective attire is designed to protect wearers from exposures to blood and other body fluids that can contain pathogens. Virtually every manufacturer of protective attire for exposure to blood or pathogens — and the two usually go together — has used the F1670 standard for the development of their products and also for use during production,” says Phillip Johnson, vice president, customer and technical services, Johnson Moen and Co. Inc., Rochester, Minnesota. Johnson is a member of ASTM Committee F23 on Personal Protective Clothing and Equipment. Committee F23 develops the test methodology to help ensure that medical protective clothing materials serve their purpose in being a barrier to blood, body fluids and other potentially infectious materials. The companion standard is ASTM F1671, which is used to demonstrate the most protective level, Level 4, for surgical gowns, as described by the Association for the Advancement of Medical Instrumentation.

Antimicrobial Safety
Germs live and thrive on surfaces and ASTM standard E1053 is a method that assesses disinfection of surfaces. E1053 most closely simulates a real-life situation of a contaminant drying on a surface before it is disinfected with a solution. This standard is cited by the U.S. Environmental Protection Agency (EPA) for disinfectant formulation acceptance. “E1053 is one of the most important methods for verifying the efficacy of product disinfectant or antiseptic product,” says Steve Zhou, Ph.D., director of virology and molecular biology, MicroBioTest Division, Microbac Laboratories Inc., Sterling, Virginia.

Hand washing is so important for all of us, not to mention healthcare providers. Two ASTM standards address how well hygienic hand wash formulations eliminate viral contaminants from finger pads (E1838) and from the entire hand (E2011).

Biopharmaceutical Safety
Committee E55 on Manufacture of Pharmaceutical Products is now tackling potential new standards for single use systems, which differ from traditional process systems in that they are disposed of after use as opposed to being cleaned. SUS are an increasingly popular method of pharmaceutical production. 

Among the proposed ASTM standards are practices for testing single use system integrity and applying such systems in pharmaceutical and biopharmaceutical manufacturing, controlling the integrity of systems during the production process and characterizing particulates.

James Vogel, P.E., founder and director of the BioProcess Institute, North Kingstown, Rhode Island, and an E55 member, says, “The standards should enhance the ability to provide a safe and efficacious biopharmaceutical product. The standards will help the industry focus on what it does well: make effective therapies to improve health, not spend time on wondering if single use technology can be used.”

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Release #9748