This interview with Mark Turner was originally published in Medical Device Developments Magazine, October 2019.
Increased interest in biologics and biosimilars is one of the factors driving the need for delivery devices at the interface between devices and pharmaceuticals.
Medical Engineering Technologies SAS, is headquartered in France and will be providing services from a base in Calais.
MET Ltd, société Britanique basée à Douvres, annonce le lancement de sa filiale Medical Engineering Technologies SAS, ouvrant ses portes en France dans la Côte d’Opale
ISO 21726:2019 Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents - is a new standard which is an aid to applying risk analysis chemical characterisation to information.
The Parliamentary Review is an organisation which promotes ‘best practice’ largely in the business environment, but also in education and healthcare. The idea is to showcase successful and well run organisations through the written word and use this information to help other organisations excel at what they do. It is supported a large group of MPs and Peers.
Both sections one and two of ISO 11607 Packaging for terminally sterilized medical devices, have been revised this year. The changes are mostly subtle, the biggest is (maybe) the addition of user evaluation of the sterile seal opening procedure and re-validation requirements.
We are very pleased to welcome Sarah Philpott into our sales department. Sarah is responsible for business development and customer relations, with a special interest in the English speaking markets: the USA, the UK, and Ireland.
MET will be exhibiting at: 2019 The Universe of Pre-filled Syringes and Injection Devices
Testing is provided to ISO 20072 Aerosol drug delivery device design verification. Requirements and test methods.
Traditionally the main area of concern regarding interactions between a formulation and a device has been limited to the container storage system for the formulation, now interest is growing in effects of drugs on devices and devices on drugs when they are used in close proximity.
This year’s audit of MET by UKAS was conducted to the new version of the gold standard QMS for testing laboratories.
Dow Corning are revising their syringe lubricant formulation. There is a surfactant change and the removal of parabens with the replacement of DC365 by DC366 (at least in Europe). Will your injection system need revalidating?
The European Medicines Agency has published draft quality requirements EMA/CHMP/QWP/BWP/259165/2019 for delivery devices and other integral and non-integral DDCs.
Non integral DDCs include such thing as refillable injector pens, inhalers and pumps. Examples of integral DDCs are non-refillable items, implants
As part of the celebration of the inauguration of or new laboratories MET staff provided conducted tours of our facilities.
Lumi explained the use of our analytical equipment and chemical characterisation services. In support of ISO 10993-18 and pharmaceutical container studies Lumi has at her disposal a wide variety of instrumentation. Here is a description of the most significant items.
Published in January, ISO 11040-6:2019 Prefilled syringes -- Part 6: Plastic barrels for injectables and sterilized sub assembled syringes ready for filling, has several changes from previous versions.
MET’s new laboratories will be opened at 11am on the 5th of April 2019 by Lord Pickles. Former member of the UK Parliament, the Right Honourable Eric Pickles has been Secretary for Communities and Local Government. He is now also the Chairman of the Parliamentary Review (a series of publications which are intended to promote best practice in business).
As part of MET’s laboratory expansion programme we are adding a dedicated physical performance testing area to implement dose accuracy studies and design validation of drug delivery devices. The new area will have 21 CFR part 11 compliant tensile equipment and balances for GMP studies. There will also be an isolation area for testing of syringes and cartridges containing cytotoxic drugs.
If a medical device has short term, surface contact it clearly does not require the same amount of vigour in the investigation of the availability of chemicals (to the end user) as a permanent implant. MET has introduced the concept of different levels of materials characterisation based on the biocompatibility matrix in ISO 10993 and part 18 of this standard.
Work on the expansion of our Chemical and Physical testing labs is now well advanced with an opening ceremony planned for the 5th of April.
The standard ISO 19761 Additional Lubricants for natural rubber condoms – effects on strength, has some significant variations from ASTM D 7661.
The EC funded SAPHELY project has now concluded with the development of a low cost microRNA analysis device being significantly advanced. The European Commission has published brief results on the Cordis web site.
Analytical Evaluation Threshold / Safety Concern Threshold, Explained
We are very pleased to announce the appointment Kevin Claris as Manager for Good Manufacturing Practice and ISO 17025 documentation, here at MET.