Newsletter - August 2009

Welcome to our August 2009 Newsletter

CERAM offers new 3D SEM Technique

CERAM introduced a new technique last month, 3D SEM. Previously only 2 dimensional SEM images were obtained, however, utilising the new technique 3D SEM images are now available. The 3D images provide topographical data including line scans and surface roughness parameters as well as having the capability of being turned into movie clips.

The 3D SEM can be utilised on almost any sample type and has excellent resolution when looking at not only flat surface but also sharp edges and non-uniform samples such as bone, fabrics and hair.

For further details please contact Rob Mitchell, e-mail rob.mitchell@ceram.com or telephone +44 (0)1782 764416.

CERAM at MEDTEC Ireland

After our successful participation in last year’s show, we will again be exhibiting at MEDTEC Ireland, this time under the CERAM banner which now fully incorporates CSMA.  The event, which is being held at the Radisson SAS hotel in Galway, is taking place on Wednesday 23rd and Thursday 24th September.

Ursula Thompson will be on hand to talk about the full range of services that CERAM has to offer to the medical device industry. 
These include:

• Contamination analysis
• Coating characterisation, including drug release
• Cleanliness validation
• Passivation studies
• QA/QC testing and analysis
• Failure analysis
• Concept, prototyping and materials formulation
• Evaluation, verification and validation of materials and medical devices
• Modelling and prototyping facilities
• Powder processing.

CERAM has been lined up to give two presentations during this year’s conference:
“The Use of Surface Chemical Analysis for the Validation of Device Cleaning Processes” – Dr. Chris Pickles.
“Material related failure modes – how gaps in materials understanding can introduce fundamental flaws into your device design” – Dr. Phil Jackson.

Come along and visit us on Stand 213.  As well as the opportunity to speak to our experts you’ll also have the chance to win a Wii Console together with a Wii Fit.

For further details please contact Ursula Thompson, e-mail ursula.thompson@ceram.com or telephone +353 469 487671.

Healthcare Open Day
Testing, Analysis & Consultancy – a CERAM Showcase

We are pleased to announce that, following the success of our Surface Analysis workshop in February, we have decided to hold an event devoted to Materials in the Healthcare industry.

This free event is open to anyone with an interest in the Medical Device, Consumer Healthcare and Pharmaceutical industries.  The day will include a morning of presentations and an afternoon of tabletop presentations/discussions, a chance to ‘Meet The Expert’ in a one-on-one confidential session and a tour of our 3DP lab.

The presentations will cover topics including:

• Cleanliness Validation
• Glass and it’s applications to the healthcare industry
• The benefits of surface characterisation.

With guest speaker Dr Mark Edwards, Director of NPR Sensodyne Future R&D of GSK Consumer Healthcare who will talk about the different types of surface analysis that CERAM has undertaken for Sensodyne including the use of DSIMS and White Light Interferometry. He will explain how this work has supported the science underpinning their products in the market with both consumers and professionals.

More information and a registration form are available at www.ceram.com/health
Alternatively, please contact Jemma Melvin on +44 (0)1782 764269.

Testing for residual Bisphenol-A (BPA)

BPA (4,4’-isopropylidene diphenol) is a monomer used in the manufacture of Polycarbonate (PC) and certain epoxies. The major properties of polycarbonate—clarity, high strength and impact resistance, good heat resistance, low water absorption, and biocompatibility—have led to its use on its own and in blends in a wide range of critical medical devices, such as catheter components, needle free IV system, blood filters in by-pass procedures.
BPA mimics estrogen and thus raises concerns about possible developmental and carcinogenic effects.
There is increasing interest in the toxicity and exposure to BPA in every day products such as food containers, baby bottles etc. Health Authorities and regulatory bodies are also showing concern relating to medical devices. The FDA is currently reviewing issues related to BPA risks and have requested voluntary information on the presence and levels of BPA for products with either direct or indirect patient contact. This would include situations where the BPA is a component of the product or its packaging. Information relating to the leaching of BPA from the packaging to the product and/or from the product to patients is also of interest.

CERAM have developed a very sensitive method for the extraction, confirmation ( ion m/z 213) and quantification of BPA and screening for phthalates can also be performed at the same time.  The detection limit is 0.2ppm which allows quantification to levels less than 1µg BPA /g. 

For further information please contact Jemma Melvin, e-mail jemma.melvin@ceram.com or telephone +44(0)1782 764269.