• Pharmaceutical
• Biologics
• Combination Product
• Medical Devices
• Toxicology

News for the Combo Product/Device Industries

WuXi AppTec sends out a periodic e-newsletter to our contacts in the combination product/medical device industry. To access previous issues, click here.

If you are not currently receiving the newsletter and would like to be on our mailing list, please email us at info@wuxiapptec.com. Please put "Combo Product-Device News" in the subject line.

For questions about any of these items or other information on WuXi AppTec’s services, contact a WuXi AppTec Account Manager.

December 2011

INDUSTRY NEWS

FDA Publishes Proposed Guidance for Reprocessing Validations of Re-Usable Devices

Recently, the FDA issued a new draft guidance related to cleaning/reprocessing validation of devices intended for multiple use in health care settings. Particularly notable is the directive that cleaning validation studies should now include not only microbial markers but also markers that are components of potential soil materials that may be left behind after cleaning. With the FDA holding that spore log reduction is not relevant to show cleaning efficacy, the best approach for acceptance is to test several markers, such as TOC, hemoglobin and protein – either with or without the addition of a microbial marker. The proposed guidance might also have an impact on the types of soil used, study extraction parameters, validation of the IFU, and use of predicate devices.

All of these changes are likely to affect manufacturers’ timelines and budgets for reprocessing validation studies. Because the FDA has not set a standard for validation and has asked for a variety of markers, this testing now requires the development of a customized test plan to address the risks specific to a device and its use. Developing this plan may take more time than previously because of the level of complexity and numbers of endpoints required. And, while the tests themselves will not take longer than before, the breadth of studies – and, therefore, the time and cost needed to perform them – may expand.

Learn what the new guidance could mean for you...
A free, live technical webinar – “FDA's Reprocessing Guidelines: Impact to Cleaning and Sterilization Studies” – will be presented by WuXi AppTec on Thursday, Dec. 15th from 1:00 to 2:00 pm (EST). The featured speaker will be Trabue Bryans, a WuXi AppTec vice president and internationally recognized expert in sterilization validation testing. To register, please click here.

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Role Evolving for Risk Assessments in Bioevaluations

Risk assessments – conducted to support the overall biological evaluation of a medical device or material once all experimental data is complete – are playing an evolving role in regulatory submissions. Both the US FDA and European Notified Bodies are now putting more emphasis on risk assessments in conjunction with biocompatibility testing – in some cases, delaying submission approval until they receive risk assessment evaluations.

According to ISO 10993-1, the initial evaluation of a device should include review and evaluation of existing data on all of the device materials and processing aids to create a preliminary assessment that is used to determine what additional testing is necessary. The selection and application of additional biocompatibility tests and materials characterization studies will often be necessary to ensure a full biological evaluation that is relevant to the product’s clinical use.

Risk assessments can be performed at different stages of device development – and for different purposes – during conduct of a biological evaluation. The initial risk assessment should include a detailed material review, with consideration of process additives, contaminants and residues, and biodegradation over time. A toxicological risk assessment following chemical characterization can also be conducted, which is consistent with ISO 10993-18. Risk assessment evaluations might also be used to support cleaning validations, product failure analysis, and material or process changes.

For a finished device or material, extractable and leachable testing may be conducted to determine the toxicological risk of leachable substances. After extraction, the levels of released chemicals are determined using analytical methods, and evaluated for hazard potential. This is done by conducting an exposure assessment, followed by a toxicity (or dose-response) evaluation and a risk characterization. For leachable chemicals, the tolerable intake (TI) may be derived as described in ISO 10993-17, Method for the Establishment of Allowable Limits for Leachable Substances.

To speak with one of our experts or for information regarding our risk assessment services, please contact your WuXi AppTec Account Manager.

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TESTING / LAB NOTES

Materials Characterization and Extractable/Leachable Chemistry Programs Expand

In Q1 2012, WuXi AppTec will be cutting the ribbon on an expanded Analytical Chemistry Laboratory in its St. Paul facility. Construction is currently underway to create 1100 square feet of additional chemistry laboratory space that will include a sample preparation and extraction room and an additional analytical lab.

We have also invested in additional state-of-the-art equipment to increase our current capabilities, including: a TOF-UPLC, micro FTIR, Ion Chromatography, HPLC Refractive Index detector and SEM- EDS. The new equipment supplements our current technologies in ICP-MS, GC-MS, HPLC and spectroscopy.

With the new lab and new equipment, we will be able to perform more materials characterization and targeted extractables/leachables programs. Expanded service offerings include identification and quantification of metals, residual solvents, anions, cations, polymer targets, as well as volatile, semi-volatile and non-volatile chemical entities from device materials.

Our analytical chemistry team has also grown, with the addition of two new chromatographers. And complementing the chemistry expansions, we have technical experts available on staff to help design and perform biocompatibility safety testing and risk assessments for your regulatory submission packages.

For more information, please contact your WuXi AppTec Account Manager.

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Enlarged Vivarium Facility Means Faster, More Flexible Response to Growing Demand

In response to growing demand, WuXi AppTec is enlarging our small animal housing facility. Expansion at the St. Paul facility began in mid-August, with completion expected this month. The additional space is custom designed to be flexible in addressing housing for rabbits, guinea pigs and small rodents, giving us the ability to adjust quickly to client needs. Located adjacent to surgical suites, the new housing rooms are perfectly situated to be used for both custom animal studies and standard biocompatibility work, as demand dictates.

The expansion creates nearly 30% more animal housing capacity and is also supported by a new equipment warehousing room. By creating space that is divided into multiple, efficient rooms, we can adapt the space to handle large, complex studies that require tight control as well as standard biocompatibility assays. Designed in compliance with the most recent guidelines from AAALAC and USDA, the new space – as well as our testing program – received high marks during our recent three-year inspection by AAALAC auditors.

With the addition of the new, flexible vivarium space, WuXi AppTec can provide our clients with even more of the high quality and responsive testing services we are known for.

For more information, please contact your WuXi AppTec Account Manager.

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