Part cleanliness is critical in the medical device manufacturing process, helping to ensure product safety, quality, and consistency. Failure to meet required cleanliness standards can have catastrophic results, including part malfunction and the transmission of infection.
However, to achieve cleanliness standards and provide testing validation, medical device makers are burdened with costly equipment purchases, environmental regulations, staff training, and numerous certification requirements.
Not surprisingly, many device producers – from small machine shops to large corporations – outsource their cleaning and validation to specialty partners, thereby eliminating significant capital expenses as well as time-consuming tasks.
Treatment for Stainless Steel Devices
Stainless steel is a popular choice for medical devices, due to its corrosion resistance. However, stainless steel can become contaminated when subsequent forming and machining operations introduce free iron particles and other surface contaminants.
These stainless steel medical devices need to meet all standards for quality and safety. Through passivation, a chemical treatment using a mild oxidant such as citric acid, contamination is removed and the spontaneous formation of a protective passive film on the steel’s surface is achieved.
It is also important to ensure that the subsequent cleaning methods used are effective in the removal of endotoxins and/or bioburden from medical devices.
Partnering with Cleaning Specialists
PTI Industries is a one-stop cleaning specialist that offers you multiple cleaning methods and the accompanying certifications and approvals. Our proven solutions are designed for a wide range of demanding applications. For the medical device industry, we specialize in precision cleaning and cleanliness testing. Expert services include:
- Measurement of particle weight down to one milligram and particle size down to five microns (.0002”)
- Cleaning with Brulin 815 and Isopropyl Alcohol (IPA)
- Availability of clean rooms from Class 1,000 to Class 100,000
- Removal of endotoxins
Save time and eliminate potentially damaging results by outsourcing your precision cleaning and testing to PTI Industries. Together, we can determine solutions to help ensure the success of your medical device manufacturing process.