Medical Devices

Cleanroom Wipe Contamination Profiles for Medical Device Wipedown & Electronics

The ideal cleanroom wipe must meet industrial and regulatory standards concerning chemical, physical, and biological compatibility. Wipe fabrics undergo a strict examination to simulate manufacturing outcomes in the real world.

Stretch and strength, chemical compatibility, task efficiency, sorbency, shed, retention, and biological harmony have unique consequences in both high-tech cleanrooms and general manufacturing floors.

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Simco-Cleanroom-ESD

Air Ionization for Particulate & Contamination Control PDF from Simco-Ion

Our friends at Simco-Ion sent us this brilliant guide to ESD cleanrooms design, principles, and other considerations. Download the PDF you’ll find case studies and technical information about how static charges influence particle retention and impact manufacturing outcomes in controlled environments. Below we’ve highlighted important ideas in relation to medical device cleanrooms and provide additional resources.

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ISO 13485:2016 Medical Devices

ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).

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Sterilization of 3D Printing Materials

Sterile 3D Printing Materials for Medical Devices

Is sterile 3D printing possible? Are 3D printed parts sterile? This comprehensive guide to 3D printing sterile parts provides materials that withstand various sterilization techniques such as autoclaving, heat, ETO, and gamma. Here’s how 3D printing will enhance medical tooling and device manufacturing.

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