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Avomeen Blog

Thursday, June 26, 2014

Medical Device Removed from Market Due to Life Threatening Manufacturing Error

This May Ventlab LLC. in Grand Rapids, Michigan, initiated a voluntary recall of resuscitator bags after discovering that the duckbill valve was sticking thereby preventing air to pass through the patient valve. The bags affected could be life threatening if used, as the lack of airflow could result in patient hypoxia and hypoventilation.

The product defect is thought to be due to incomplete curing during the manufacturing process. This error only effects certain lots and the full list of suspected failed lots can be found at:

Manufacturing errors such as incomplete curing are not an unusual failure, however they have dire consequences. There have been 31 reports of delayed medical care due to professionals having to use two or three of the resuscitation devices to assist a patient. There has also be one reported injury due to the defective bags.

Especially when it comes to medical devices, product defects and failures are of the utmost concern. Companies must take immediate action to not only remove the defective product from the market, but also to solve the production error by finding the source of the product defect. When this occurs the manufacturer is often unable to identify the cause of the failure and must consult expert help to pin point the defect source.

Avomeen Analytical Services provides exceptional product failure analysis. Utilizing state-of-the-art instrumentation and methodology our scientists examine products at the elemental level to isolate contaminants, compare good vs. batches of product, and determine the source of a manufacturing failure. These services help companies such as Ventlab identify and address their problem, allowing them to quickly resume production and sale of their medical devices.

More information regarding Avomeen’s Product Defect/Failure Analysis can be found on our website at:

For immediate assistance with product analysis call us at 800-930-5450 or email Scientist@avomeen.com

We look forward to working with you to solve your complex production problems!

Friday, June 13, 2014

Avomeen Invites Attendees at BIO 2014 International Convention to Connect at Booth #1259

June 23-26, 2014 Avomeen will be exhibiting their wide range of pharmaceutical services at this year’s 2014 BIO Convention. They invite all attendees to visit their booth #1259 to learn more about how their specialized chemists can solve even the toughest problems throughout the pharmaceutical development process. As a top contract research organization (CRO) we offer services from pre-formulation through to stability analysis.

Our chemists have over 30 years of experience providing expert analysis for early stage drug development through to extractables/leachables testing and so much more. We are excited to share our skills with the thousands of organizations attending the event this year and hope to develop lasting relationships to benefit attendees’ current and future project needs.

Many biotech companies, pharmaceutical researchers, and academic institutions come to BIO with specific questions and current project needs already in mind. Avomeen’s representatives will be meeting individuals at booth #1259 to set up consultations and provide answers to even the toughest of these problems.
Whether your company is attending the conference with current analytical testing needs, or simply looking to network for future collaboration, we hope to meet you at this year’s convention.

Our pharmaceutical services include:
  • ·         Method Development & Validation
  • ·         Preformulation & Formulation
  • ·         Extractables & Leachables
  • ·         Stability & Release Testing
  • ·         Degradation Analysis
  • ·         Clinical Trial Manufacturing
  • ·         Defect & Failure Analysis
  • ·         Counterfeit Analysis
  • ·         Litigation Support Services

Call our Ph.D. scientist today to receive an initial consultation and visit us at BIO to discover how we can take you product to the next step.

Phone: 800-930-5450

Monday, June 2, 2014

Michigan’s Great Lakes Threatened by Pollution Caused from Cosmetic Microbeads – New Study Reveals

06/02/14 - NPR recently reported Dr. Sherri Mason’s research on the newest pollutant in the Great Lakes, cosmetic microbeads.  These beads which are used in a variety of exfoliating body scrubs, facial cleaners, and other cosmetic products are actually tiny pieces of plastic.  Lead by Professor Mason the State University of New York at Fredonia students collected samples of debris in the lakes by dragging a net that caught all objects greater than a third of a millimeter.

This sampling revealed there to be approximately 17,000 of these plastic pieces per square kilometer in Lake Michigan.  Lake Erie and Ontario have higher levels of plastic particles while Lake Huron and Superior have lower.

The concern of these bits of plastic entering the lakes revolves around their impact to the total ecosystem.  Primarily, these beads are thought to potentially increase the level of harmful toxins entering the food chain.  These microbeads can absorb toxins and the researchers are concerned that those toxic chemicals could then be passed to wildlife and eventually humans as the beads are so small in size they appear as food to many organisms living in the water. 

These findings are effecting New York legislature as a ban on microbeads is quickly rising through legislative branches. If this legislation is indeed made law, New York manufacturers will only have until December of 2015 to completely phase out products with microbeads. This legislative change will not only effect New York but equivalent laws are making their way through Illinois while the other lake states are thought to quickly join suite.

Product manufacturers are urged to proactively begin creating alternative products with natural exfoliants such as apricot seeds, sand, or cocoa beans.  Avomeen’s product development laboratory has already helped manufacturers reformulate facial scrubs modifying their formulations to include alternative bio-degradable materials instead of utilizing microbeads.  Avomeen’s  CEO Shri Thanedar Ph.D. hopes more companies will realize that their products’ formulations can be reformulated or re-engineered to remove harmful ingredients while creating an end product that meets the same or even improved upon specifications as the original product.

Reach out to Avomeen’s skilled chemists today for a complimentary initial consultation and see how they  can help you keep the Great Lakes clean, protect your brands image, and keep your products ahead of upcoming legislative changes.

Avomeen Analytical Services
Product Testing & Formulation Development Laboratory
4840 Venture Drive
Ann Arbor, MI 48108

Phone: 800-930-5450

Website: www.avomeen.com

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Avomeen Analytical Services
4840 Venture Dr.
Ann Arbor, MI 48108
Phone: 1-800-930-5450
Fax: 1-800-930-5479
Email: scientist@avomeen.com