Product category:
R&D, Test and Evaluation Services
News Release from: Smithers Rapra
Edited by the Processingtalk Editorial
Team on 31 May 2005
Rapra Technology invests in
pharmaceutical growth
Rapra Technology has appointed Phil Rabone as business development manager to grow and develop the Rapra services and consultancy for the pharmaceutical industry
Rapra Technology, Europe's leading research and test centre for plastics and rubber, has appointed Phil Rabone, MSc, CChem, MRSC as business development manager to grow and develop the Rapra Technology services and consultancy for the pharmaceutical industry Rabone is a Chartered Chemist with over 30 years industrial experience; the last fifteen of which have been spent working in the developing pharmaceutical sector including periods with Fisons Pharmaceuticals, Rhone-Poulenc Rorer and CCL Pharmaceuticals
This article was originally published on Processingtalk on 12 Feb 2004 at 8.00am (UK)
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Pharmaceutical company compliance with an increasing volume of product regulation and testing is now growing Rapra's business in this marketplace- particularly in respect of polymeric materials that are in contact with pharmaceuticals, whether in packaging or in healthcare delivery systems.
'There is an undeniable volume growth in the amount of polymeric material and product knowledge - analysis, testing and validation - now needed in the pharmaceutical industry,' notes David Ingles, Manager for the Technology Sales Group.
'Developing regulations in Europe now make it compulsory, for example, for extractables and leachables studies to be carried out on new pharmaceutical products.
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These kinds of studies are precisely the kind of cost effective and expert services that we provide at Rapra Technology.
Part of Phil's new role will be to draw industry attention to these outsourced services in materials and product analysis and testing - and to then develop them further.
Phil Rabone says that 'the pharmaceutical industry is now in real need of the plastics and rubber expertise, which is readily available from Rapra Technology.
It is a significant part of my job to raise the Rapra profile within the pharmaceutical industry and my initial soundings show a real delight and relief among users that plastics and rubber expertise and services are indeed readily available and can be supplied either 'off the shelf' or customised to the specialist demands of the client'.
Rabone says that 'pharmaceutical producers are coming under more and more pressure: regulatory guidelines, particularly for the administration of pulmonary and nasal drugs specify that studies must now be carried out to establish levels of extractables and leachables from plastics or rubber componentry in drug products.
This increasingly high level of regulation means that pharmaceutical companies need to find peace of mind that their new material formulations will continue to perform as predicted throughout their shelf life.
We at Rapra supply the peace of mind through scientific method and validation - specifically with the appropriate studies, according to FDA/CDER guidelines.
We are also able to offer a method development and validation services for clients'.
Rabone adds that 'by virtue of its consumer marketplace, the pharmaceutical sector is somewhat similar to the food industry and has similar needs.
The recent public scare over the Sudan food colouring additive - and the subsequent large scale withdrawal from the marketplace of hundreds of products - gives a hint of the issues at stake when the testing and analytical services are not in place.
These issues weigh even larger for the pharmaceutical sector.
It is therefore essential for companies to be watertight in their product analysis and testing'.
The Rapra growing list of services to the pharmaceutical industry includes:.* Extractables and leachables testing.* Compliance testing to FDA/CFR Regulations.* Pharmacopoeia testing (USP, JP and EP).* Identification and quantification of degradation products from polymeric medical devices - ISO 10993.* Identification of polymeric contaminants in drug products.* Failure analysis of pharmaceutical and medical products.* Accelerated aging and stability studies.
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