Introduction: Leachables are chemical entities that migrate from one material matrix into another. In medical device and pharmaceutical development, leaching occurs under normal storage conditions, when chemicals from a delivery device or packaging migrate into and potentially impact the safety or efficacy of a drug substance. Consequently, regulatory bodies often require exhaustive investigations into the leachable profile of a device to ensure patient safety.
Case Study: A medical device manufacturer approached EKG Labs regarding the possibility of a plasticizer leaching from prototype pulmonary devices. There was growing regulatory concern that the plasticizer acts as endocrine disruptor and may pose a danger to human health. Therefore, the manufacturer was anxious to see if the plasticizer was leaching from their new device.
To determine if the plasticizer was a concern, EKG Labs extracted the device material in water over 30 days and took samples of the extract at days 1, 3, 5, 15 and 30. Control samples were similarly prepared. Then, all samples were tested by HPLC against the plasticizer’s reference standard.
The HPLC chromatogram of the plasticizer reference standard showed a retention time of 13.183 minutes:
Day 1 showed the presence of the plasticizer:
The concentration of the plasticizer continued to increase up to the 30 day end point of the study:
The full table of results from Days 1-30 is listed below.
Conclusion: The analysis showed conclusively that the plasticizer was leaching from the pulmonary device on Day 1. Continued leaching was seen up to Day 30. As a result, the medical device manufacturer began investigating plasticizer alternatives that would not cause potential health problems for end users.
Additional Analysis: Often an extractables (the chemical that can be forced out of device or packaging) investigation is done in conjunction with, or prior to, a leachables study in order to get a full profile of the potential hazards of a medical device. This typically incorporates an analysis of storage stability under a variety of controlled conditions. In the course of these programs it is often necessary to characterize and identify all relevant extractables and leachables. It may also be necessary to develop and validate methods to monitor these chemicals if they are a potential concern.
If you are looking to fulfill regulatory requirements or are experiencing challenges in your medical device development, please contact us at 810-354-5229 to find out how we can help you.
About EKG Labs
EKG Labs is an analytical service provider for the medical device and pharmaceutical industries. Our analytical services support regulatory filings, product development, and analytical chemistry investigations. Specialty analytical services include: extractables, leachables, biocompatibility, characterization, impurity identification, method development, method validation, deformulation, and other investigational activities.