Drug/device compatibility testing is a critical component of pharmaceutical and medical device development. It ensures that when a drug interacts with a medical device, there are no adverse effects on the drug’s efficacy, the device’s performance, or patient safety. Infinity Laboratories specializes in providing comprehensive drug/device compatibility testing to support product development and regulatory submissions.
Key Tests for Compatibility
Key Tests for Compatibility
Infinity Laboratories conducts a variety of tests to evaluate the interaction between drugs and medical devices. One of the most essential evaluations is in-use stability testing, which determines whether a drug remains chemically and physically stable during its interaction with the device. This includes assays to monitor drug impurities and appearance testing to assess chemical stability.
For devices, physical stability tests assess whether prolonged exposure to a drug affects the integrity of the device. For example, a catheter’s durability is evaluated to ensure that no degradation occurs during use. Testing for particulate matter and leachable impurities is also crucial, as these could pose significant risks to patient safety.
Identifying Potential Problems
Identifying Potential Problems
Many clients come to Infinity Laboratories unaware of potential compatibility challenges. Testing often reveals critical issues, such as flow rate inconsistencies in delivery pumps or the degradation of tubing materials. These findings allow clients to adjust their product formulations or select alternative devices to prevent further complications.
The earlier these evaluations are performed, the better. Identifying incompatibilities late in development can lead to costly reformulations or redesigns. Infinity Laboratories helps clients uncover these issues early, minimizing delays and ensuring a smoother path to market.
A Collaborative Approach
A Collaborative Approach
Infinity Laboratories stands out for its collaborative and flexible approach. Unlike larger, transactional laboratories, Infinity partners closely with clients, acting as an extension of their team. This partnership enables real-time problem-solving and tailored solutions for complex testing scenarios.
For example, when clients encounter unexpected changes in flow rates or stability concerns, Infinity Laboratories works with them to hypothesize potential causes and design experiments to pinpoint the source. This level of granularity and adaptability ensures that clients receive actionable insights to move their projects forward.
Supporting Innovation with Tailored Expertise
Supporting Innovation with Tailored Expertise
The expertise at Infinity Laboratories goes beyond routine testing. Their ability to design and execute studies that mimic clinical conditions ensures reliable and relevant results. This is particularly valuable for long-term stability studies, where precise conditions must be replicated to generate meaningful data.
With a focus on accuracy and collaboration, Infinity Laboratories helps clients navigate the complexities of drug/device compatibility testing. Their services provide the clarity and confidence needed to bring innovative products to market safely.
Start a Conversation Today
Start a Conversation Today
Infinity Laboratories is committed to supporting clients at every stage of their development journey. Contact Infinity Laboratories to discuss your drug/device compatibility needs and discover how their tailored solutions can help ensure the success of your project.