Last week’s post discussed the importance of selecting the right fabric, and how fabrics and formula chemistry work together. Today’s post discusses labeling best-practices and regulatory considerations.
(3) Know the FDA and EPA Requirements. Introduction of a disinfecting or sanitizing wet wipe product requires knowledge of kill claims, efficacy studies, and federal and state requirements for labeling.
Regulatory requirements vary depending upon the intended use of your wet wipe product. Wipes intended for cleansing or moisturizing the skin, such as those for baby care, hand washing, makeup removal, or the application of deodorants are regulated as cosmetics.
The Federal Drug Administration (FDA) has legal authority over cosmetics that is different from other products such as drugs, biologics and medical devices. Cosmetic products and ingredients do not need FDA pre-market approval, apart from color additives. However, cosmetics must be properly labeled and product safety information must be shared with FDA.
Wipes intended for a therapeutic purpose, such as killing germs on the skin, or treating acne, diaper rash, or other skin conditions, are considered Class I Medical Devices by the FDA and must meet requirements for FDA approval for safety and effectiveness before they go on the market.
Wipes intended to disinfect or sanitize against germs on inanimate surfaces are regulated by the Environmental Protection Agency. Wipes intended for cleaning objects in our homes, at work and in public places are regulated by the Consumer Product Safety Commission.
Figure 2: Multi-Pack Solutions Milwaukee WI location.
Multi-Pack Solutions is FDA registered and fully compliant at the Greenville, South Carolina and Milwaukee, Wisconsin facilities. Both are registered with the FDA as a Medical Device & Drug Establishment. In addition, all three Multi-Pack Solutions facilities, including the Chicago, Illinois location are registered with the EPA and compliant to applicable regulations. EPA requirements include proper registration of products, efficacy or kill claim data and product labeling.
In addition to FDA, EPA and Medical Device registrations, the Greenville, South Carolina facility of Multi-Pack Solutions partners with an industry-recognized ISO certification body to maintain registration and certification to ISO 13485 to meet all Medical Device directives, regulations and responsibilities.
Multi-Pack Solutions is proud of, and willing to share with its customers, an excellent history of FDA Inspections due to its diligence in maintaining quality systems.
(4) Avoid Any Preservative Surprises. Once a formula is added to a wipe fabric, it can serve as a food source or growth medium for various microorganisms; therefore, formulas must include the proper preservatives to kill microorganisms such as bacteria, mold or yeast that can grow on wipes.
A common way of preventing the growth of microorganisms in consumer products is to adjust the pH level making it either too acidic (low pH) or too basic (high pH) to support microbial life.
For example, many cleaning products have pH values of around 11 vs. the neutral value of seven which helps with the effectiveness of the cleaner. Very few microorganisms can grow in such a high pH level environment, so certain cleaning wipe formulas may not require additional chemical preservatives.
It is important to perform a Preservative Challenge Test on a formulation to determine if the preservative chosen for the product is compatible. FDA/EPA guidelines also recommend an additional challenge test as part of stability testing of the product’s intended shelf life. Subsequent testing will be necessary to re-evaluate the product’s preservative effectiveness whenever the formulation, an associated manufacturing process or product packaging changes occur.
Next week’s post will discuss labeling recommendations and regulatory considerations.