By Jennifer Gygi, Study Director, Packaging
Over the last 5+ years, the FDA has been tightening the regulations on personal lubricants to ensure they are safe since they are often used in body contact and also to ensure they do not degrade condoms. The new ASTM D7661-10 standard is the FDA approved method for determining condom compatibility. This new standard clearly lays out the required sample numbers and test methodology for demonstrating condom compatibility.
By Adrianne Sandall, Aerobiology Study Director, Nelson Laboratories Inc.
If you are a manufacturer of respirators, one of the most important processes you must go through is to receive certification from the National Institute for Occupational Safety and Health (NIOSH). NIOSH respirator certification is necessary in order to label your respirator with one of the three “N” certification categories: N95, N99 or N100. N95 respirators are used to filter contaminants such as dust, fumes, mists, as well as microbial agents including tuberculosis bacteria and flu virus. They are certified to filter greater than or equal to 95 percent of all challenged particles free of oil and greater than 0.3 microns in size. N99 respirators filter greater than or equal to 99 percent, and N100 respirators filter greater than or equal to 99.97 percent of all challenged particles free of oil and greater than 0.3 microns in size.
By Tonya Morris, BS, SM(NRCM), ASQ CQA, Pharmaceutical Section Leader, Nelson Laboratories
Antimicrobial Preservative Efficacy (APE) testing ensures that preserved products are sufficiently protected from microbiological contamination that has been introduced during or subsequent to the manufacturing process. A wide variety of products require APE testing including injectable drugs, toothpaste, contact lens solution and cosmetics.
By Derek Peterson, EO Sterilization Study Director
Ethylene oxide (EO) is a widely accepted form of sterilization for medical devices that are sensitive to radiation or heat.
Batch release sterilization is ideal for medical device manufactures whose devices are very specialized and expensive to produce thus limiting device quantities, or devices that are not in the final device or packaging configuration where conducting a full EO sterilization validation would be impractical. Batch release sterilization is an efficient way to obtain small quantities of devices that are deemed suitable for human use regardless of the design or production phase of the device. Batch release sterilization can produce as much as hundreds or thousands of sterile product for human use or as little as one single device.
-Scientist to highlight additional testing processes and strategic plans-
SALT LAKE CITY – April 11, 2012
– Nelson Labs (www.nelsonlabs.com
) Laboratory Manager Dan Floyd, RM(NRCM), will present to medical device manufacturers attending the BIOMEDevice Boston Exposition and Conference,
April 25-26 at the Boston Convention and Exhibition Center. Floyd was selected to present Ethylene Oxide Sterilization of Small or Infrequent Lots: Batch Release Method
at the Innovation Briefs Theater
, booth #1051, on Wednesday, April 25 at 12:30 p.m.