Due to the COVID-19 pandemic, many organizations globally have transitioned from creating their standard product lines to manufacturing hand sanitizers and other disinfectants using their in-house raw materials due to a significantly increased need and limited supply. Companies may have little to no experience in this realm, but have the tools, materials and know-how to help in the fight against COVID-19.
With that being said, there are still quality guidelines set by the FDA, along with other regulatory agencies like the EPA, to ensure these sanitizers and disinfectants meet safety requirements and hold up to marketing claims.
Avomeen can help companies transform their raw materials into high-quality sanitizers and disinfectants in addition to final product testing ensuring safe, high-performing products enter the marketplace. We will determine the efficacy of your product, screen for known contaminants, and can provide your results in a certificate of analysis (CoA). It is incredibly important to do this to prevent product recalls and/or financial loss.
Why do Raw Materials Need to be Tested?
The testing of raw materials is extremely important to:
- Ensure the products are safe for the intended use, and
- Screen the ingredients for any potentially hazardous impurities
According to the FDA, ethanol and IPA-based hand sanitizers must contain 60% ethanol or 70% IPA by volume to be considered effective disinfecting agents. By testing your hand sanitizer solution, you can ensure efficacy as well as confirm that all necessary standards have been met.
How are Sanitizer & Disinfectant Raw Materials Tested?
Avomeen can test sanitizers and disinfectants raw materials, in addition to finished products. We can also verify the percentage of isopropyl alcohol (IPA) or ethanol in finished products and chemical characterization of product packaging including polymeric tubing, filters, plastic, polymers, etc.
There are two primary tests for ensuring alcohol content:
Ethanol Testing via USP Methodology
USP has specific standards to ensure ethanol meets the acceptance criteria to be utilized as a component. Avomeen can also test to verify not only is your ethanol free of any volatile impurities, but that it meets or exceeds the needed percentage for your sanitizer solution.
Isopropyl Testing per USP Methodology
Avomeen can also similarly test isopropyl to verify that as a component, your isopropyl has no hazardous impurities or foreign substances and that your final product, whether disinfectant or sanitizer, has the correct concentration for the FDA’s current guidelines.
Avomeen is Experienced in Rapid-Turn Sanitizer and Raw Material Testing
Avomeen is an FDA-Registered, DEA-Licensed, cGMP-Compliant laboratory equipped to handle any kind project you may have, large or small. Let our chemists guide you through the process while ensuring your much-needed products meet FDA’s temporary COVID-19 policies and guidance. Avomeen is prioritizing all COVID-19 related projects to guarantee timely project completion. If you’re ready to get started, connect with an expert here.
Our expert blogger is John Ferencz, Avomeen’s Project Lead, Trace Element & Contaminant Analysis. Clients benefit greatly from his extensive experience developing, implementing and optimizing analytical methods used in both research and development and current good manufacturing practice environments. John’s proficiency in performing validation and verification for both developed and transferred analytical methods per U.S. FDA, U.S. Pharmacopeial Convention, U.S. EPA and U.S. Geological Survey guidelines helps clients to ensure compliance with regulations such as USP 232 and USP 233, as well as California Proposition 65. John’s expertise extends to a variety of industries including nutraceuticals, food and drink, and regulatory compliance.