analytical chemistry
Welcome to STS Analytical Chemistry
Ethox STS offers customized and standard analytical chemistry testing for the medical device and pharmaceutical industries. Our Analytical Chemistry department is housed in a newly designed facility with state-of-the-art testing equipment, featuring an environmentally controlled suite and Class 100 laminar flow hoods.
our focus
 • Solutions customized to your product and needs
• Ethylene oxide residual analysis after sterilization
• Particle sizing and counting per USP, JP, EP or other guidelines
The wide variety of analytical techniques available include:
• gas chromatography (GC)
• high performance liquid chromatography (HPLC)
• infrared spectroscopy (FTIR)
• ultraviolet-visible spectroscopy
• classical wet chemistry
• particle size and number analysis using light microscopy and light obscuration techniques.
our services
Ethylene Oxide Residual Tests
Ethox STS takes great pride in being at the forefront of the ongoing continuing worldwide efforts to standardize ethylene oxide residual testing. Knowledge of the proper ways to process samples ensures reliable results, prompt turnaround, and cost savings.
Examination of a device before testing is critical in deciding how the testing is to be conducted (i.e. what parts to extract, duration of patient exposure, applicable regulatory limits).
Preliminary testing to identify any problems that could occur during actual testing is also conducted. This includes device dissection (if necessary), extraction procedure, and determination of any potential interfering substances which can cause erroneous (generally, "higher") residual values. Once these factors are understood, a an Ethox proposal for the analysis of your product is developed for your review and approval.
Ethox STS Analytical Chemistry performs all ethylene oxide residual testing in compliance with the guidelines provided by ANSI/AAMI/ISO 10993-7.
Ethox STS EtO residual tests are conducted using proven methodology and well established practices in instrumental analysis, calibration and system suitability criteria. Clients can be confident that all supporting data relevant to their test results are documented and traceable to procedures recognized and accepted by regulatory agencies. In addition, the department is skilled in working with clients to develop test protocols which will satisfy the requirements of non-US regulators.
See our Regulatory page»
our tests
Ethox STS offers a wide range of analytical chemistry tests. Learn more»
related services
 Coordinating Client Projects
Analytical Chemistry performs studies separately or in conjunction with other STS services. This approach serves to streamline client's studies utilizing our multi-service capabilities:
• Microbiology testing
• Toxicology testing
• Reusable medical device testing
• Contract Sterilization
• Biological Indicators
certifications
See certifications
To learn more call Dave Warner at 1.800.836.4850 or e-mail us!
|
