A recent feature in NONWOVENS INDUSTRY reveals a movement toward manufacturers achieving FDA, EPA approval to demonstrate safety and effectiveness in certain types of wipes. The article includes insights from Kleen Test Products. See the excerpts below. Read the full article, Focus On: Regulated Wipes.
Barb Noel, business development manager at Kleen Test Products, adds that it is important that wipes manufacturers have regulatory staff who are familiar with the processes and procedures in place to comply with strict cGMPs when manufacturing regulated products. Kleen Test Products helps many of its customers launch regulated products with both the FDA and the EPA.
“Many customers who want to sell a disinfecting or sanitizing product will work with a company who already has a product registered with the EPA,” she says. “They will sub-register the product from the owner of the registered product.”
FDA, EPA Approval for Wipes
As far as FDA approved wipes, Kleen Test manufactures many FDA regulated products for the medical and health and beauty markets. These products, which are used on the skin, include acne pads and first aid wipes and have active ingredients such as benzoyl peroxide, hydrogen peroxide, isopropyl alcohol and salicylic acid.
Kleen Test also produces a number of EPA surface disinfecting products for wipes that are used on hard surfaces. Typical active ingredients that are used in these products are Quaternary compounds, alcohol, bleach and hydrogen peroxide.
“Some of these active ingredients require specialized filling facilities and equipment. Kleen Test Products has the infrastructure and equipment necessary to manufacture these products under both FDA and EPA guidelines,” Noel explains.
Registered wipes are good business for companies that can comply with the regulations, she adds. “If you can meet these requirements, it sets you apart from other manufacturers who do not have the infrastructure to handle the FDA, EPA approval and requirements for these products. Since Kleen Test Products offers these technical services in house, we can help our customers get products into the marketplace efficiently and in compliance with all applicable regulations.”
Take a closer look at Kleen Test Product’s wet wipe innovations.