Newsletter - March 2009

Welcome to our March 2009 Newsletter

New White Paper Stresses Importance of Understanding Materials for the Medical Device Industry

Last week we published a white paper, highlighting how critical a knowledge of materials and their characteristics is to the medical device industry. How A Detailed Understanding of Materials is Playing a Vital role in the Evolution of Medical Device Technology explains how access to comprehensive materials evaluation data will allow medical device companies to make informed decisions on material selection, substitution, and qualification and QA programs and how issues such as contamination and cleanliness can be investigated.

The white paper is available at www.ceram.com/medical

Low Volume Gas Analysis (LVGA) finds application in Vacuum Pack Testing

A leading manufacturer of orthopaedic medical device components commissioned a study to determine the extent of batch-to-batch variability in packaging gas composition following routine gas flushing and vacuum sealing of their UHMWPE implants. The gas composition of batches of packed products was compared to control samples (packaging with known gas composition) to ensure batches were within the acceptable range of gas concentrations. The products were routinely sealed under vacuum following flushing with an inert gas so that the residual gas volumes within the sealed pouch available for testing was low.

The method of gas composition analysis was developed by CERAM Surface and Materials Analysis using a specially modified mass spectrometer, Quadrupole SIMS. The instrument was fitted with a side chamber enabling in vacuo rupturing of the packaging combined with controlled leakage of the resulting internal atmosphere into a Low Volume Gas Analyser system. The mass of the gas fragments was measured in the LVGA to identify the whole pack gas composition.

The benefit of this technique over more conventional gas sampling methods, such as syringe extraction, is the ability to analyse the very small quantities of gas remaining once the packs have been evacuated following gas flushing.

A number of vacuum-packed pouches were analysed, following flushing with inert gas (argon). High quality data were generated giving superior compositional accuracy for a five-gas mixture with trace level sensitivity down to less than 0.05 atomic%. The variations in residual gas level were found to be consistent and acceptable. Only trace amounts of hydrogen, water vapour and oxygen were detectable, demonstrating the capacity of the technique to detect extremely low gas levels.

The study confirmed that there were no differences in gas composition between the tested batches and control batches of medical device packaging. The manufacturer concluded, therefore, that the gas flushing process was operating correctly and consistently.

Introducing Dave Shingler

Dave Shingler joined CSMA on the 2nd Feb from CERAM’s testing division.  Having joined CERAM in 1984, Dave has worked in areas such as physical testing, thermal analysis of ceramic materials, particle size analysis and ceramic research, as well as being involved in developing new tests and techniques including microwave digestion and laser ablation for ICP-OES, FIA Colorimetry and AFS spectrometry for a range of industries.
Dave comments: “I am very much looking forward to the challenge of applying my experience and problem-solving skills to the exciting and new area of surface analysis with the team at CSMA.”

Win a Sony eBook Reader by visiting CERAM at MEDTEC UK, Stand 4021

After our successful attendance at MEDTEC UK in 2008, we will be exhibiting at this year’s event at the NEC in Birmingham from the 25th-26th March.

Visit us on stand 4021 to discuss our services including:

• Delaminations and disbondments analysis
• Contamination analysis including fibres, specks, particulates and thin films
• Coating Characterisation including uniformity, composition and thickness
• Validation of raw materials, cleanliness and processes
• Investigation of packaging failures
• Quality control of gas-filled packaging
• Testing of orthopaedic implants; metallurgic
• Batch conformity testing of synthetic bone material and ceramic implants
• Consultancy Services
• And for a chance to win a Sony e-Book Reader PRS-505.

Another Successful Surface Analysis Workshop

CSMA’s latest surface analysis workshop was held on the 26th Feb, with attendees from a range of industries including defence, medical, automotive, material and composite manufacturers and suppliers.
As with previous workshops, the day was split between presentations and time in the laboratory.

Delegates commented “I took away a firmer understanding of how surface analysis can help my business”, “The one-to-one discussion was particularly helpful in determining my needs” and “A well organized and useful overview of surface analysis methodologies”.

The next workshop will be held on 22nd October with full details to follow. To register your interest please contact jemma.melvin@ceram.com