Cambridge Polymer Wishes You a Swell 2024
Thirsty the Hydrogel Was a sodium polyacrylate soul With a Bakelite pipe and a resin nose And two eyes made by injection mold Oh, Thirsty the Hydrogel Is a feat of science, so they say He was made of fake snow And the lab techs know How he wicked moisture away There must have been […]
Look Where the Bullets Are Not
Figure 1: Compilation of bullet hole damage found on planes that returned from battle. In analysis of data, bias can lead to an incorrect interpretation of the data if the analyst has a firmly-held preconceived notion of the study outcome, or if a complete dataset is not considered. The analyst may not be aware that […]
Recent Non-Volatile Residue Standardization at ASTM
Although this title manages to capture three yawn-inducing groups of words[1] (“non-volatile residue,” “standardization”, and “ASTM”), when these groups are combined, they represent an important subject for manufacturers of medical devices. Non-volatile residues (NVR) are those residues that can be removed from a medical device that are not intended to be part of the device, […]
Going the Distance for Material Science and Ironman
CPG Employee Spotlight: Dr. Rebecca Bader Dr. Rebecca Bader is Cambridge Polymer Group’s Associate Director of Chromatography and our biocompatibility specialist. She has a PhD in Materials Science from Oregon State, a master’s in chemistry from Princeton, and has taught biomedical engineering at Syracuse University. Becky worked for CPG for four years until 2019 when […]
Powder Bed Additive Manufacturing of Medical Devices
Many medical devices, including surgical tools, cutting templates, trial devices, and long term implants, are produced using additive manufacturing technology via the powder bed fusion (PBF) process. PBF offers a significant benefit in medical device production by enabling the creation of highly customized and patient-specific solutions. PBF in Medical Device Manufacture However, this unique manufacturing […]
Highlights from the ASTM F04 Workshop on Medical Device Cleaning Limits 2023
Committee F04 on Medical Devices sponsored a workshop on discussion setting limits for residues on medical devices during cleaning validation on May 9, 2023 in Denver, CO. The conference was organized by Stephen Spiegelberg (Cambridge Polymer Group) and Ralph Basile (Healthmark), and included presenters from testing laboratories, device manufacturers, material manufacturers, regulators, toxicologists, and cleaning […]
New Ethylene Oxide Sterilization Standards Proposed
The Environmental Protection Agency (EPA) is proposing new standards on chemicals used to sterilize medical devices, including ethylene oxide (EO/EtO), one of the more commonly used sterilants. However, ethylene oxide has recently been scrutinized due to safety concerns about workers’ EtO exposure at sterilization facilities. The EPA is proposing a decrease in the highest allowable […]
Registration Open for ASTM F04 Workshop on Cleaning Medical Devices
Registration is open for ASTM International’s Workshop on Setting Acceptance Limits for Cleaning Validation of Medical Devices, to be held May 9, 2023 at the Sheraton Denver Downtown Hotel (Denver, Colorado, USA). The event is sponsored by ASTM’s medical and surgical materials and devices committee (F04) and will be held in conjunction with the May […]
O Thou, My Muse! Guid Auld Scotch Drink!
At the end of January, Scots and poetry lovers around the world gather to celebrate the birthday of Scotland’s most famous poet, Robert (or Rabbie) Burns. Burns Night guests sit at long tables sipping Scotch while the haggis is paraded about the room, followed by a bagpiper playing musical tribute to Scotland’s traditional Haggis. Burns’ […]
ASTM F04 Cleaning Validation Workshop – Call for Presentations
May 9, 2023 – Setting Acceptance Limits for Cleaning Validation of Medical Devices Sheraton Denver Downtown, Denver, CO, USA. For general information about the workshop, please visit the event website. About the Event Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices, the workshop will be held in conjunction with the May […]