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MANUFACTURING MEDICAL DEVICES IN THE USA SINCE 1935

MANUFACTURING MEDICAL DEVICES IN THE USA SINCE 1935

OEM

The Propper Research & Development Team

Propper Research and Development

Propper’s Research and Development teams are all headed by project leaders with PhDs and years of experience in medical device development. Propper employees serve vital positions on national medical device committees, such as AAMI (the Association for the Advancement of Medical Instrumentation) and help to shape the recommended practices used by manufacturers, hospitals and other healthcare facilities.

Propper researchers are trained in all aspects of product development, from initial design through product scale-up to final production. This allows employees to be able to directly answer any technical questions regarding product performance or capabilities.

Medical Device OEM

Propper Manufacturing Headquarters

Propper utilizes the latest technological advancements to offer the most innovative solutions to medical device OEM customers throughout the world. Propper puts an emphasis of cost-effective solutions that are environmentally friendly and can tailor products to meet particular requirements while maintaining ISO and FDA compliance. Propper’s experienced design teams and flexible research and development personnel work together to generate designs that can fit into already existing plans or potential product lines.

Propper is capable of designing chemical indicators that use sterilant specific inks that can be printed in a variety of ways: offset, flexographic, silkscreen, or lithographic processes. Propper uses indicator inks that can be either water or solvent based.

Chemical Indicators

Class 5 Integrator


Propper has developed a complete line of non-toxic indicators that comply with both the FDA and ISO 11140 requirements. Class 1 through 6 indicators that comply with ISO 11140-1,4,5 are available. Also available are FDA cleared process indicators, air removal indicators, integrators and emulators. Propper has developed indicators that can validate steam, ethylene oxide, dry heat, formaldehyde/chemical vapor, or hydrogen peroxide sterilization processes.

 

 

Biological Indicators

Biological Indicators

Propper manufactures a complete line of biological indicators that are compliant with FDA and ISO requirements. Available biological indicators may be compliant with USP and/or ISO 11138 and are available for saturated steam, ethylene oxide, dry heat, and formaldehyde/chemical vapor processes. The product line includes self-contained biological indicators, biological indicator strips, incubators, media, and biological indicator compatible process challenge devices.

 

The Propper Equipment

Propper believes in investing in the latest technology and has eight ISO 18472 compliant resistometers capable of maintaining extremely precise sterilization conditions. In addition to these resistometers, Propper also maintains a fleet of traditional hospital type sterilizers capable of running gravity and pre-vacuum steam, ethylene oxide, formaldehyde, hydrogen peroxide gas plasma and dry heat sterilization cycles. Propper’s highly trained technicians handle equipment maintenance and calibration in house and utilize dataloggers to verify that the resistometers are in top working condition.

Propper also emphasizes novel approaches not specified in performance standards in order to enhance product development. Examples include spectrophotometric measurements of indicator color in order to reduce variability, programmable environmental chambers to test the effects of temperature and humidity fluctuations on component parts as well as completed products, UV lamps to simulate the effects of sunlight exposure, spectrometers to determine the presence of any leachables in product formulations, and pulping studies to test product component recyclability.