Medical Device Manufacturing Cleanrooms
Pollutants like dust, microbes, and particulates can negatively impact the efficacy of medical devices. As a result, patient health and well-being depend on the manufacturer’s ability to maintain a safe and sterile environment during production.
Hudson Medical Innovations takes every step possible to ensure each component leaves our facility without a doubt of compromise. Our Wisconsin medical device contract manufacturing facility contains four spaces that exceed the requirements of ISO 14644, which sets the standard for cleanroom manufacturing.
Benefits of cleanrooms
A medical device manufacturing cleanroom is a controlled environment where pollutants like dust, airborne microbes, and aerosol particles are filtered out to create the cleanest area possible. Cleanrooms are regulated by the International Organization for Standardization, or ISO, in the United States by ISO 14644-1.
By fabricating, assembling, inspecting, and bagging medical devices in cleanroom environments, sterility and regulatory compliance is easily achievable. Other advantages of clean room manufacturing are:
- Stability
- Reliability
- Control
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contact us request informationWhy Hudson Medical Innovations
Advanced Technology and Personnel
Specialize In Custom Based Projects
Inhouse Equipment Experts
Converting Technology Patents
The high purity edge
Quality standards are increasingly stringent in the medical device industries. It’s for that reason Hudson Medical Innovations offers ISO 14644-certified cleanroom environments to all our customers.
To ensure the cleanroom meets the required standard, a pressurized environment is created by introducing air passed through a ceiling-level filter. It keeps contaminants from entering the room. Personnel working in the cleanrooms wear protective clothing.
Improve your medical device’s performance by partnering with Hudson Medical Innovations. Our cleanrooms provide an elevated amount of control over operations and functionality, reassuring clients that the medical devices they receive are reliable.
If you have questions regarding our cleanrooms’ suitability for your requirements, please feel free to contact our expert team. They’re happy to discuss your situation in further detail.
Hudson Medical Innovations
2251 Willis Miller Drive
Hudson, WI 54016
715.386.3774
