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Antimicrobial Product Chemistry: Understanding EPA Requirements

The U.S. Environmental Protection Agency requires antimicrobial product registrants to provide product chemistry data to support purported label claims. Applicants must supply technical information describing the product’s active and inert ingredients, manufacturing or formulating processes, and physical an chemical characteristics. This white paper provides a simplified summary of the general guidance on these seemingly complex… Read More

Product Storage Stability: Considerations & Primary Concerns

To confirm product integrity and effectiveness throughout its shelf-life, EPA requires critical data  to support antimicrobial product storage stability.  While the EPA OPPTS guideslines have established a framework for testing, storage stability presents particular challenges including storage conditions, intervals and nominal concentration determinations. In an industry when time to market is critical, a clear understanding of the requirements,… Read More

Reusable Medical Device Challenges

Reprocessing IFU Development and Validation Reusable medical device manufacturers are required by the U.S. Food and Drug Administration (FDA) to ensure all sets of cleaning instructions are validated and meet the parameters indicated on a device’s labeling. In light of 2015  news items on the use of potentially contaminated endoscopes in Los Angeles, Seattle and Philadelphia.

Disinfection Qualification Testing: Considerations for the Aseptic and Cleanroom Manufacturing Environment

Disinfection qualifications are critical in assuring the microbial control of a manufacturing environment by qualifying the appropriate use and effectiveness of disinfection products and procedures. Obtaining the highest confidence that aseptic, cleanroom, and other critical manufacturing environments are properly cleaned, sanitized and disinfected is paramount in assuring the production of safe and effective pharmaceutical products… Read More

Enforcement Analytical Method Validation: 9 Parameters to Consider

The United States Environmental Protection Agency (EPA) requires registrants to provide toxicology data, antimicrobial efficacy data and product chemistry data to support the purported label claims for antimicrobial products designed to protect public health in the United States. As a part of the product chemistry data, the EPA’s Office of Chemical Safety and Pollution Prevention… Read More

Regulatory Overview of Antimicrobial Product Public Health Claims in the United States

Antimicrobial products intended to protect the public health are regulated as pesticides in the United States by the Environmental Protection Agency (EPA). Before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. This white paper,… Read More