- Validoinnin yhteenveto-opas
Pumpsil platinum-cured silicone tubing
Pumpsil and its raw materials have been tested under a range of pharmacopoeial and non pharmacopoeial standards. These include:
- USP Biocompatibility in vivo and in vitro
- European Pharmacopoeia, 3.1.9
- ISO 10993
- EC 1935/2004
Additional testing carried out includes extractables testing.
The full validation guide including additional information regarding test methods and actual test reports is available on request.
Pumpsil, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the Pumpsil compliance guide.
Pumpsil additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004. The declaration of compliance can be found here.
Both the full validation guide and the compliance guide can be requested by submitting the below form.
