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| Rapra
Healthcare - Polymer Analysis and Testing Services |
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 Over
the last decade Rapra has developed into one of Europe’s
foremost polymer testing and consultancy providers for the global
Healthcare Industry. The range of services offered draws on
the considerable expertise of our highly qualified staff and
the vast experience built up through over 90 years of problem
solving for industry.
Rapra’s
knowledge of the requirements of the healthcare industry has
enabled us to develop a range of services providing assistance
and support to the key disciplines that are part of the modern
product development and regulation throughout the lifespan
of the device.
'Aventis has often used Rapra Technology for work in "immediate"
situations - ie work that is not always foreseen or planned
- appropriate skilled resource to be committed at a moments
notice.I can say that, in these stressful situations Aventis
has never been let down by Rapra Technology who have probably
pushed their organisation out of shape to deliver.'
David
Shadwell, Aventis Pharma
Materials
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Materials selection
Rapra can assist with the selection of the most appropriate
materials for a given application giving consideration to
“fitness for purpose”, safety and quality, durability
and regulatory requirements.
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Design advice
We can assist with the transition from concept to production
taking account of “best design practise”.
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Materials equivalence
Demonstration of equivalence and sourcing of alternative
grades or materials.
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Process design and specification
Regulatory
- Interpretation
of product specific requirements of national and international
standards including FDA/CFR regulations and National Pharmacoepiae.
- Provision
of information to enable biological and chemical safety
assessments as part of the risk analysis process.
Testing
- Extractables
and leachables studies for drug or body contact materials
- Stability
studies
- Compliance
testing to CFR/FDA regulations
- Pharmacopeia
testing (USP, JP and EP)
- Materials
characterisation (eg 10993 Pt 18)
- Physical
and chemical testing
- Accelerated
ageing and stability studies
- Performance
testing
- Generation
of ad hoc test protocols
Failure
diagnosis
- Identification
of failure modes and effects
- Risk
analysis
- Corrective
actions
- Contamination
identification
- Specification
compliance
Training
and Education
We
offer courses in Healthcare materials characterisation –
with special reference to ISO 10993 Pt 18 – and training
and eduction in FDA approval and qualification, including
elements as extractables and leachables.
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| Contact Rapra Technical
Services at info@rapra.net or +44 (0)
1939 252413 |
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