Private Labeling Services
Medical Device Original Equipment Manufacturer
Propper Manufacturing Company is a trusted OEM for some of the largest brands worldwide. Propper utilizes the latest technological advancements to offer OEM customers innovative medical devices. We collaborate with OEM customers to develop the most cost-effective, environmentally friendly, tailored products. All while maintaining customer-specific needs keeping the solutions ISO and FDA compliance. Propper’s experienced design team and professional research and development personnel work together to create products and marketing materials that fit existing product lines or develop new product categories.
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Propper has developed a complete line of non-toxic indicators that comply with both the FDA and ISO 11140-1,4,5 requirements. Type 1 through 6 indicators that comply with ISO 11140-1 are available. Also available are FDA cleared process indicators, air removal indicators, integrators and emulators. Propper indicators monitor attainment of critical sterilization parameters in steam, ethylene oxide, dry heat, formaldehyde/chemical vapor, peracetic acid, or hydrogen peroxide sterilization processes.
Propper manufactures chemical indicators that use environmentally friendly ink that can be printed in a variety of ways to be sure your product is perfect for you. Propper uses indicator inks that are biodegradable and latex, DNR, TSE, and BSE free, which can be either water or solvent based.
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, vaporized and liquid peroxide. The product line includes self-contained biological indicators, biological indicator strips, incubators, media, and biological indicator process challenge devices.
The Propper Equipment
Propper believes in investing in the latest technology and utilizes ISO 18472 compliant resistometers capable of maintaining extremely precise sterilization conditions. Propper also maintains a fleet of traditional hospital type sterilizers capable of running gravity and pre-vacuum steam, ethylene oxide, hydrogen peroxide gas plasma and dry heat sterilization cycles. Propper’s highly trained technicians handle equipment maintenance and calibration to make sure that all instruments in are in top working condition.
Propper also emphasizes novel approaches not specified in performance standards to enhance product development. Our lab capabilities include, spectrophotometric measurements of indicator color to reduce variability, programmable environmental chambers to test the effects of temperature and humidity fluctuations on component parts and products, UV lamps to simulate the effects of sunlight exposure, spectrometers to determine the presence of any leachables in product formulations.