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Medical Devices

 Description of Industry

The medical device industry is thriving and becoming more and more competitive. Mergers and acquisitions continue to make competition all the more challenging.  Equipment and devices employed by the medical industry are held to exceptionally high standards.  Anything that can create unwanted attention for your company such as  recalls and FDA investigations should be of highest priority for risk pre-mitigation.

Off-odors are particularly problematic in this industry  because they cast doubt on quality and cleanliness.  VAC has vast experience with odorous chemicals of importance to the FDA (for example, highly odorous haloanisoles such as TCA, TBA and their precursor compounds halophenols such as TCP, and TBP). Whether your company needs assistance with integrating odor prevention into your quality protocols or support with odor/aroma in product development, sensory training, aroma profile development, or  litigation,  Volatile works with your team to accomplish your requirements.

 

Applicable Services

What we do

All of VAC services apply to the medical device industry. Volatile can work with your existing protocols and demonstrate where odor evaluations needs to added and/or expanded. Additionally, our team can help by assessing production processes for precursor chemicals that contribute to the creation of unwanted odorous chemicals. Finally our team can help create monitoring tools including sensory and analytical for odor management.

Odor Analysis GC-MS/O

Gas chromatography-mass spectrometry/olfactometry provides the very best technique to quickly resolve off-odor issues. This method requires a trained odor judge to sniff GC effluent and rate odor character and intensity. This information is coupled by retention time automatically via software to GC-MS chromatogram data to allow for rapid odor identification. Our sensory and analytical team have more than 20 years experience with odor, analytical, and organic chemistry, and sensory analysis. Read more about our GC-MS/O Odor Analysis service by clicking HERE.

Odor Baseline Establishment

Baseline GC-MS/O measurements have proved extremely helpful to our clients because they establish the aroma and chemical profile of a product considered good.  When odor problems arise new GC-MS/O analyses can rapidly determine what chemical changes occurred compared with a product considered good to allow for production process examination and off odor mitigation. For more on this service click HERE.

New Product Development Aroma Support

To ensure new products exhibit desired aroma character and intensity, we employ spot-on sensory assessment, extraction methods and analytical analysis. Sensory includes quantitative descriptive analysis to ensure the attributes measured match those desired. Extraction methods depend on the nature of the material. Dynamic headspace extraction works for many products however specialized techniques such as sir bar sorptive extraction and solid phase micro-extraction also have a place. Analytical may employ GC-MS, GC-MS-MS,  GC-MS/O, or other method appropriate to answer a specific question. If you need more information about how we can provide aroma support for new product development click HERE.

Odor Investigation

We utilize the most advanced scientific techniques and instruments currently available to detect and measure volatile chemicals responsible for odor.  We utilize gas chromatography-mass spectrometry/ olfactometry  to quickly determine what retention index values from a chromatogram correspond with odor.  This capability dramatically improves our capability to identify trace level chemicals responsible for off-odors.

Odor Problems and Complaints

Medical instruments are a target for off odor. On FDA’s website, examples of recalls due to odor in medical devices are listed. One such example originated in the electronics of the device, yielding a burning odor (Nellcor Puritan Bennett, 980 Ventilator System – Component Failure May Cause Burning Odor.) Other examples of opportunities for odor to impact medical devices can be found in the use of common cleaning agents. These agents have chemicals that, in the right conditions, can create off odor such as the musty odor of TCA, TBA. Odor is a real problem in the medical industry.  It quickly brings attention by consumers and regulators even when chemicals are non-toxic. The unknowns can put you at risk.  Volatile will work with you to proactively prepare your team to address these issues before they impact your bottom line.

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