Pace Analytical Life Sciences provides material characterization testing to support our medical device clients by assisting in establishing biocompatibility of a Medical Device by identifying and quantifying the chemical constituents of the materials. This testing can be used to determine material toxicology, typically following ISO 10993-18 methods. Some of the material characterization testing that we perform includes:
Our material characterization testing lab is often tasked to help discern any qualitative and quantitative differences between similar materials from one or more suppliers. If materials are shown to be indiscernible through laboratory testing, and the materials have the same performance characteristics, the materials are usually considered interchangeable.
Material characterization testing can include Molecular Weight Determination and distribution utilizing Gel Permeation Chromatography (GPC) and using Refractive Index detection. Once the Molecular weight distribution of a polymer material is known, the Inherent Viscosity can be measured and mapped back to the GPC data to determine average Molecular Weight values. This provides a quick Quality Control check that can detect lot to lot variations. Inherent and Intrinsic viscosity measurements are determined using our automated viscometer.
An application frequently requested in our material characterization testing laboratory is a simple assessment of surface cleanliness. Materials and pieces used in medical devices may be handled multiple times, by multiple departments and/or specialty contractors. To maintain quality control through these multiple steps, a simple testing procedure is needed to confirm that the materials have been properly handled.
Variations on a frequently used procedure may include a rinsing with Purified Water for Injection (WFI), with or without agitation for a period of time at a specified temperature. The material will be removed from the container and the rinsate will be separated into aliquots for one or more analyses that typically include:
Our material characterization laboratory is often asked to develop a sampling technique to recover a specific analyte of interest and to develop an analytical method that is sensitive enough to quantify the recovered analyte at low levels. The specific analyte may be an ingredient of the product, a component related to product, and/or a commercially-available mold-release agent or cleaning agent / detergent.
The sample collection method might involve a collection of rinsate or a swabbing. This collection method is dependent upon analyte recovery and the needed detection limits. The analytical method might involve any of a number of laboratory instrumentation and techniques, dependent upon analyte recovery and detection limits. The method might be quantitative, semi-quantitative or simply a limit test, dependent upon the detection and sensitivity of analytic techniques and methodologies available.
If the parts are demonstrated to be adequately cleaned on multiple subsequent occasions, one may extrapolate the data to characterize the robustness and repeatability of the cleaning agents and standard cleaning procedures employed.
Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.
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