Safely transfer, sample, and store biopharmaceutical products and reagents
- Secure, single-piece cap/tubing assembly eliminates contamination and product loss due to loose connections
- Assemblies are gamma irradiated—eliminates labor and validation costs associated with assembly and cleaning
Cap assembly includes a seamless liner with premolded TPE fill and vent tubes to create an unobstructed fluid path. The 24” (61 cm) fill tube is plugged at the terminal end to maintain assembly sterility until use. Vent tube includes a 25-mm diameter, 0.2-micron PVDF disc filter to prevent contamination. The vent filter is hydrophobic to offer protection loss of product during filling or emptying. The one-piece liner eliminates the risk of bacterial entrapment and contamination and forms an elastomeric seal between the cap and bottle rim.
Puri-Flex™ biopharma tubing meets USP Class VI, FDA 21 CFR 177.2600, and ISO 10993 Part (S) 4/5 requirements. This sealable/weldable TPE tubing has excellent gas barrier properties, low permeability, and is resistant to acids and alkaline. The smooth inner surface reduces platelet adhesion and protein binding.
Bottle assemblies are assembled in an ISO Class 7 cleanroom and are gamma irradiated up to 40 kGy. Each assembly is individually double bagged with a cleanroom label and gamma dot.