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Laboratory Gains ISO 17025 Accreditation for Transit Simulation

Medical Engineering Technologies Ltd


Medical Engineering Technologies’ packaging laboratory now has ISTA 2A and ASTM D4169 transit testing added to its accreditation.

The lab is fully equipped with vibration simulators for road and air transport, and impact testers for rail switching, concentrated impact and rough handling, with support from stacking simulators.

These processes are normally preceded by 72 hours conditioning. We have many options available – freezing, tropical, desert and more. The following process is sterile barrier validation through seal strength and integrity testing.

Combine this service with our stability studies and on-site machine validations and you will have everything covered for ISO 11607.

For more information click here.

To see our new accreditation certificate click here.
phone +44 845 458 8924
email solutions@met.uk.com
web WWW.MET.UK.COM
email Unit 16, Holmestone Road, Dover, Kent, CT17 0UF, UK
 
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News and Press Releases

Haselmeier Relies on DQIQOQ Qualified Testing Machines and Zwicks Materials Testing Laboratory

Haselmeier is a leader in the development and manufacture of innovative self injection devices. Numerous international pharmaceutical manufacturers are customers of this Swiss company. In addition to testing production batches of pen injectors, Zwick's Materials Testing Laboratory offers DQ/IQ/OQ qualification and measurement system analysis of the testing system used for the tests.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

Clinical Trial Supply East coast 2018

16-17 October 2018, King of Prussia, PA

This unique event brings together leading pharma, device and biotech professionals from across the East Coast region, to collaboratively enhance the clinical supply chain. Over the two days, delegates and speakers will discuss how to select forecasting and planning technology, how to reduce waste in clinical trials supplies, how to choose your packaging strategy, but we will also discover all the new technologies that will disrupt your clinical trials supplies.
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