Extractables and Leachables – Testing and Consulting. - Solvias
Extractables and Leachables – Testing and Consulting. - Solvias
Extractables and Leachables – Testing and Consulting. - Solvias
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<strong>Extractables</strong> <strong>and</strong> <strong>Leachables</strong> <strong>–</strong><br />
<strong>Testing</strong> <strong>and</strong> <strong>Consulting</strong>.
Ever wondered what leaks out of<br />
your single-use equipment?
Production System Materials<br />
Single-Use / Disposable Systems<br />
According to BPSA recommendations<br />
• Bags<br />
• Filters, columns<br />
• Syringes<br />
• Tubings, fittings, gaskets
What plastic additive migrates into<br />
your drug product?
Container Closure Systems<br />
In compliance with relevant FDA <strong>and</strong> EMA guidelines<br />
testing according to latest PQRI recommendations<br />
• Primary <strong>and</strong> secondary packaging<br />
• Inhalation devices, prefilled syringes<br />
• Bottles, blister packs, vials<br />
• Ophthalmic bottles <strong>and</strong> tubes, transdermals<br />
• Labels, adhesive, ink
Do you need to demonstrate the safety<br />
of your medical device?
Medical Devices<br />
According to ISO 10993 <strong>and</strong>/or relevant FDA/EMA guidelines<br />
• Inhalers (MDI, DPI)<br />
• Injection devices (pens, syringes)<br />
• Bags, tubings, LPVs <strong>and</strong> corresponding tubing <strong>and</strong> catheters<br />
• Infusion pumps<br />
• Implantable medical devices
<strong>Solvias</strong> Services...<br />
• Established workflow for rapid <strong>and</strong> meaningful<br />
extractables studies<br />
• Screening by high mass accuracy LC/MS <strong>and</strong> LC/MS/MS<br />
• Proprietary LC/MS database with over 3000 entries of<br />
polymer additives<br />
• Confirmation of LC/MS by GC/MS up to mol weight of 700<br />
• Data interpretation by experienced polymer chemists<br />
• In-house storage facility<br />
• Consultancy<br />
• Toxicological assessments<br />
• Full GMP compliance<br />
• Professional project management<br />
...provide perfect peace of mind.
<strong>Solvias</strong> AG<br />
Römerpark 2<br />
4303 Kaiseraugst<br />
Switzerl<strong>and</strong><br />
Tel. +41 61 845 60 00<br />
Fax +41 61 845 69 00<br />
info@solvias.com<br />
www.solvias.com
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