Resources and Expertise

News & Information

Our Expertise, Your Competitive Advantage

Life Science Outsourcing’s veteran team of experts shares cutting-edge resources, regulatory insights, and partner-ready solutions.
Technical Terms Glossary
Decoding the language of medical device manufacturing
Plastic tray filled with syringes and needle holder with a Tyvek lid.
Medical Package Testing

Unveiling the Vital Role of the Sterile Barrier in Medical Device Packaging

A packaging sterile barrier acts as a super-shield around the device. This protective cocoon prevents contamination during storage and distribution. Validating the sterile barrier is essentially a quality check to ensure the device can withstand its shelf life with sterility intact until the end user is ready to open it.
Medical device neatly placed in a tray, securely sealed with a Tyvek cover.
Medical Package Testing

Tyvek: The Ideal Versatile Solution for Medical Device Packaging Needs

Tyvek has taken the medical device packaging world by storm, becoming the preferred choice over many plastic and paper options. Its unique properties satisfy stringent regulations and ensure the safety and efficacy of medical devices during transportation, handling, and opening. Manufacturers now have access to this versatile solution that not only meets regulatory demands but also guarantees numerous benefits (like being waterproof AND tearproof).
Package design is critical to a new medical device product launch. Avoid costly delays and better understand the process with our medical device packaging checklist.
Medical Package Testing

Unpacking Success: Medical Device Packaging Checklist for Successful Product Launches

This article discusses the importance of understanding packaging requirements for medical device companies during product launches. While the launch of a new medical device can be exciting, it can also be accompanied by anxiety, especially for start-up companies who may not fully comprehend the packaging process.
Conducting a sterile barrier testing, such as the ASTM F1929-12 dye leak test, is crucial for confirming the integrity of medical packaging seals.
Medical Package Testing

6 Methods for Medical Package Sterile Barrier Validation Testing: INFOGRAPHIC

Validation testing ensures your medical device’s packaging sterile barrier stays intact – no matter what it’s exposed to during processing, sitting on a shelf, or during transit. View an infographic tool with details on the six different ways validation testing occurs based on packaging elements.
Why Medical Device Distribution Testing is Necessary
Medical Package Testing

Preventing Damage and Maintaining a Sterile Barrier: Why Medical Device Distribution Testing is Necessary

Medical devices must be reliably shipped across the country and around the world to arrive intact at their destinations for a positive impact on human health. Yet improper packaging preparation can mean the sometimes life-saving medical devices arrive in less-than-optimal condition. Medical device manufacturers must take all mandated and recommended packaging steps to ensure such a dismal outcome does not come to pass. That includes medical package testing.
Medical Package Testing: Anatomy of a Protocol
Medical Package Testing

Medical Package Testing: Anatomy of a Protocol

When does medical package testing require a protocol? What exactly is involved? Read the answers here, along with why a proper written and approved protocol should always be considered.
Medical Package Testing

What is Dunnage and How Can it Reduce Medical Package Testing Costs?

What is dunnage and what does it have to do with medical package testing? Find out in our latest article which details the ways dunnage can reduce medical package testing costs without derailing regulatory approvals.
Medical Package Testing

Design Terminally Sterile Packaging 3 Ways to Prevent ISO 11607 Package Design Failure (Infographic)

Your medical device product likely needs terminally sterile package design to deliver to market.

We're going to MD&M Minneapolis!

Booth #3820

Let's meet at the show!