A new product is available from AdvantaPure: AdvantaSil Ultra Low Temperature Silicone Tubing. This platinum-cured tubing is designed for single-use, cold temperature applications in biopharma and pharmaceutical processing such as bulk drug storage and transport.
AdvantaSil Ultra Low Temperature Silicone Tubing offers a solution to the challenge of safeguarding today's high-value drug products. AdvantaSil Ultra Low Temperature tubing is the first commercially-available silicone tubing engineered to withstand flexing and manipulation within a 86°C (122.8°F) freezer. Flex and crush testing conducted on gamma-irradiated tubing showed no cracking or loss of integrity – see the video above. The tubing has also undergone drop and storage testing.
"Customers have been asking for this,” noted Gregg Donovan, AdvantaPure Product Manager. "They need tubing they can have confidence in – a product they know won't break down or crack in the extremely low temperatures used for cell, drug and media storage and sampling. AdvantaSil Ultra Low Temp was designed specifically for these types of applications."
Other features include:
- Meets USP Class VI, FDA CFR 177.2600, ISO 10993, and European Pharmacopeia 3.1.9 standards
- Optimises freezer utilisation – no protective clam shell is needed for the tubing
- Available as bulk tubing, molded manifold tubing assemblies, BioClosure® container closures with tubing, or as part of a bag assembly
- General temperature range: 112°C to 175°C (169.6°F to 347°F)
- Sterilizable by autoclave or gamma irradiation
- Certified free of animal-derived ingredients
- Documented quality control per ISO 9001:2015
- Full BPOG standardised extractables test protocol is in process
AdvantaSil Ultra Low Temperature Silicone Tubing is offered in five sizes ranging from 1/8” through 1/2” I.D. Single-Use assemblies with moulded tees, wyes, crosses and reducer connectors are available through custom order, as are bag assemblies and container closures. Gamma irradiated tubing and assemblies are also available.