Projects

This client was experiencing field failures in a critical component of a gas valve. The polymer was degrading and the client needed to know if this failure was due to chemical or mechanical erosion. ACCTA, Inc. assisted in reviewing in-house testing and simulations, evaluating operating environments, and studying the known chemical reactivity of the polymer. A review of the entire assembly, and its operating environment, suggested that the failure was due to chemical erosion, catalyzed by a nearby metallic component that was degrading. A series of thermogravimetric experiments proved the degradation hypothesis. These results allowed the manufacturer to make better decisions about the choice of components for this system.

ACCTA, Inc. reviews the components and formulation of water purification devices such as tap filters, reverse osmosis units, and water softeners. From this review, ACCTA, Inc. provides a list of target compounds that may inadvertently leach into drinking water during use. We are able to provide this information through our extensive experience in chemical analysis, materials formulations, and a knowledge of the behavior of chemical species. The laboratory uses this report to plan appropriate testing and to help identify the source of unwanted leachables.

This client wanted additional information on the composition of products it was selling to customers. The information was needed to support existing sales and aid in development of companion products. ACCTA, Inc. provided a complete analysis of the major components and developed analytical methods to determine the quantity of active ingredient present.

This client needed new formulations for existing products, and new formulations for new products and product variations. In some cases, completely new formulations were needed, while in other cases, a variation on existing products was desired. ACCTA, Inc. provided the necessary review of formulation options, prepared initial batches for field testing, and developed initial procedures to support manufacturing.

One series of studies involved preliminary testing of implantable device stability under simulated use (stored in physiological saline). The study design, developed in cooperation with the client, involved storage of multiple replicates at three different temperatures over various time periods. Several physical and chemical parameters were measured at initiation, during storage, and at study termination. Some parameters followed an Arrhenius relationship. After statistical data interpretation, a study report was completed for each product design.

In other studies, both real-time and accelerated storage stability studies were designed and implemented. ACCTA, Inc. coordinated storage and testing, and prepared both interim and final reports.

This client was experiencing problems with the analytical method for verifying purity of a raw material. ACCTA, Inc. assisted in selecting new chromatographic stationary phases and operating conditions. An experimental design strategy helped to identify the critical operating variables. These improvements reduced the cost of testing from approximately $9/sample to less than $2/sample.

Each facility was using packed column gas chromatography to determine ethylene oxide (ETO) residuals in finished medical devices. Training in the fundamentals and operation of a gas chromatograph was required after transfer of the instrument to a different group. ACCTA, Inc. developed training materials and performed the training, using both lecture and hands-on activities.

At one facility, the instrument was upgraded to capillary column technology, and conditions were optimized so that the manufacturer could determine the three analytes of interest in a single injection, rather than two, for each sample. The final method was then validated.

For a more detailed description of this upgrade project, click here.

This startup company had a novel, non-surgical idea for treating a medical condition that normally required major surgery. This device would only be useful if a suitable carrier could be developed to allow easy insertion in a non-surgical environment. ACCTA, Inc. performed literature searches to identify candidate hydrogels, obtained materials, and performed initial experiments to optimize the design.

These manufacturers were completing their applications for a CE mark, which would allow unrestricted sales of their medical devices in Europe. This effort involved the following services:
1) review of technical file sections for scientific and grammatical correctness,
2) response to reviewer comments and questions, and
3) risk analysis (literature review, identification of risks, discussion of risks).

For one client, ACCTA, Inc. also assisted in preparation and review of an IDE, which was ultimately approved by FDA.