Reprocessing Single Use Medical Devices
Single use medical devices cannot be re-used without FDA compliant reprocessing procedures. Essentially reprocessing a single use device constitutes manufacturing it which requires compliance with FDA medical device manufacturing regulations. Appropriate cleaners must be chosen and cleaning validations done.
Alconox, Inc. cleaners can be used for medical device reprocessing cleaning. Alconox provides technical bulletins, books, and support for the use and validation of their cleaners, such as this Medical Device Whitepaper and Guidebook and our Medical Device Cleaning Validation References PDF.
Aluminum Eletrostatic Filter Soak
Q. I am looking for a soak cleaner for my aluminum electrostatic filter in my air purifier.
A. I recommend you soak in a warm 2% solution of Citranox. Citranox will not attack aluminum and is an effective soaking detergent. Download the Citranox MSDS or Technical Bulletin. To test an Alconox, Inc. detergent for free, please complete the questionnaire at Get Sample. And if you have a question for our experts about critical cleaning, please visit Ask Alconox.
Alconox Cleaning Validation Literature
Q. Does Alconox offer literature on cleaning validation?
A. Alconox, Inc, Critical Cleaning Experts, provide a variety of cleaning validation information, which includes validation literature. Click to access the download info.
Electronics Cleaner – Circuit Boards w/ Alodine
A customer needed to clean an assembly of a printed circuit board which had been sweat soldered to an aluminum plate/heatsink/carrier. The company needed a cleaner that would not attack the Alodine coated aluminum backside or the gold pockets or solder reflowed surface of the circuit board.
Unfortunately, the current cleaner was slightly base ph 9+ and the water slightly alkaline as well coming in at a ph of 8.0. This, along with other factors, caused staining, darkening and spotty discoloration of the 6061 Alodine coated (chemical conversion coating) aluminum parts.
Medical Device Cleaning – Silicone & Metal Adhesion
Q. We manufacture metal parts in house and overmold (LIM) with silicone. We often have adhesion problems between the silicone and metal. We believe the problem is with our current cleaning process. I would like you to recommend a new cleaner that we can test.
A. If having silicone and metal adhesion issues in medical device cleaning, use the hottest practical temperature you can to remove silicone residues. I recommend you clean with very hot 2% Alconox (20 g/L of 2.5 oz/gal) detergent.