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ARTICLES & NEWS

News and Medical Device Packaging Insights from Pro-Tech Design & Manufacturing

EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging

EO Sterilization & Medical Device Packaging Sterilization is a critical step in the manufacture of medical devices, as it helps to ensure that the devices are free of harmful microorganisms and safe for use. Ethylene Oxide (EO) sterilization is one of the most...

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The Medical Device Packaging Development Process

The Medical Device Packaging Development Process

The Medical Device Packaging Development Process When it comes to successfully commercializing medical devices, the packaging process plays an incredibly important role. This process involves various steps, such as design and layout, materials selection, sterilization...

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What is ASTM F1980 and Why Should You Care?

What is ASTM F1980 and Why Should You Care?

What is ASTM F1980 and Why Should You Care? For medical device packaging, one essential criterion is that the packaging you choose protects the device and maintains its sterile integrity over the shelf-life of the product. ASTM F1980 is the industry standard that...

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Fundamentals of the CAPA Quality Process

Fundamentals of the CAPA Quality Process

An Introduction to Medical Device Contract Manufacturing A good medical device contract manufacturer must have a rigorous quality system in place to ensure that the device is protected and safe for use.  Part of that system should include a detailed corrective and...

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How to Navigate an Audit During a Pandemic

How to Navigate an Audit During a Pandemic

For anyone in the medical device industry, ISO Audits are stressful enough and there is a lot riding on them. However, in the current situation, now you add the challenges of a pandemic and remote communication on top of it. As part of a recent renewal audit for our...

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NEWS

ISO 17025 Lab Testing Accreditation

We are excited to share that PRO-TECH has been officially certified to conduct bioburden, LAL, and sterile barrier system testing at our Santa Fe Springs, CA headquarters. After months of quality testing, submissions, and a virtual certification audit, our lab is...

PRO-TECH Response to COVID-19

12/16/2020 Update Given the increase in COVID cases around the country, we wanted to provide an update as we close out 2020. We continue to be vigilant about cleaning, mask-wearing and social distancing protocols to keep our employees safe and to maintain operations....