One-stop expertise for combination device testing
The rapidly accelerating demand for combination pharmaceutical products continues to fuel innovation and create many exciting opportunities that will bring promising new options to the medical community in advancing patient care and outcomes. However, the convergence of drugs/biologics and devices brings a host of new challenges in product development and testing.
DDL has nearly 30 years of first-hand experience navigating complex testing standards and industry regulations for medical devices and combination products. Our expertise and reputation for extraordinary, responsive service keep projects on track through tight development timelines.
We specialize testing the following types of combination products:
- Pre-filled Syringes
- Needle-based Injection Systems
- Vials and Cartridges
Our testing expertise includes:
- Test method and protocol generation
- Design verification testing
- Shelf-life/stability studies
- ISO 11607 packaging validation
- USP 1207 container closure integrity testing (CCIT)
- Particulate identification and analysis
- Complaint handling
- Delamination studies
Pre-Filled Syringe Testing
The use of pre-filled syringes is becoming more and more prevalent as the preferred delivery device for parenteral drug products. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration, helping to reduce drug waste and dosage errors while also improving safety.
We conduct performance and mechanical testing of pre-filled syringes per the recommendations set out by the FDA in their guidance document and the related industry standards, including long-term stability studies to validate performance throughout the target shelf-life.
Contact us for more information or to talk to an engineer.
Designing a Pre-Filled Syringe Test Plan Webinar
Companies developing pre-filled syringe combination products are often put in a bind when it comes to timing and execution of design verification studies. All too often, product rolls off the manufacturing line and then is rush shipped to testing sites for expedited service. Working with a test lab that is seasoned, responsive and flexible can certainly make these hectic situations less severe for the entire program. This information-rich webinar highlights DDL’s best practices for ensuring a test program is established on firm ground and executed flawlessly.
What we do at DDL matters to the lives of people. This is what drives us to become the most responsive and intelligently resourceful testing experts.
“As Medtronic Sofamor Danek begins to offer more sterile product, we rely heavily on DDLto support our integrity testing to validate the package. Different scenarios occur with each project and it is good to know that we can discuss each situation with Scott and the gang at DDL. The experience we have with DDL is good in that we always get quick responses and attentiveness with all our projects. It’s also nice to work with experienced people that are there whenever we ask for the impossible.”