Silicone Platinum AdvantaSil® APST
Activité : Single Use Process
Type : Single Use components, Tubing/Hose
Brand : AdvantaPure
Silicone Platinum AdvantaSil® APST
Low volatile grade, platinum-cured silicone tubing is clean room produced for critical pharmaceutical, biopharm, cosmetic, and food applications.
AdvantaSil® APST platinum cured tubing has undergone extensive physical, chemical, and biological testing, and meets USP Class VI, FDA CFR 177.2600, ISO 10993, NSF 51 and European Pharmacopoeia 3.1.9 standards.
Full BPOG standardized extractables test protocol has been performed by a fully-accredited, third-party test lab.
Main features :
- Tubing silicone platinum USP Class VI, FDA CFR 177.2600
- All assembly and final packaging of extruded tubing is performed in an ISO Class 7 clean room
- Extractibles validation according to BPOG
- 90% of the reference available in the USA and France
- Certified free of animal-derived ingredients
- Sterilizable by autoclave or gamma radiation
Some recommended applications :
- Aseptic transfer
- Media & buffer preparation
- Upstream (cell culture)
- Downstream (Chromatography, TFF)
- Fill & Finish
- Sterilizing Filtration
- Repartition, Formulation
- USP Class VI
- FDA CFR 177.2600
- ISO 10993
- 3A 18-03
- Pharmacopée Européenne 3.1.9
- Dossier de validation complet disponible sur demande
- Test BPOG
Additional features :
- Hardness : 50 Shore A
- Diamètres disponibles de 0,8 à 25 mm interne (1/32’’ à 1’’)
- General temperature range: -100° F (-73.3° C) to 400° F (204.4° C)
- Available in coils of 7,6 m, 15,2 m & 30,5 m (25, 50 ou 100 feet)
- Documented lot traceable with identification on packaging
- Particulate testing per USP 788 is performed quarterly