Bio-Simplex Media Bottle Assembly Systems
Each closed-system design includes a PETG Square Media Bottle and a 2-port EZ Top¨ closure assembly consisting of a 0.2 _M vent filter, an 18-inch length of tubing with a plug end, a notched dip tube that extends to the bottom of the bottle, and a polyethylene cap. The EZ Top assembly is made from C-Flex¨ pharmaceutical-grade thermoplastic elastomer (TPE) resin.
The entire system is engineered to ensure an unobstructed fluid path, extremely low levels of extractables and a secure elastomeric seal between closure and bottle. Economically designed for the single-use market, these systems are easily used with sterile connecting devices and thermal tubing sealers.
They are sold as single items, double-bagged and gamma irradiated to achieve a Sterility Assurance Level (SAL) of 10-6 per ANSI/AAMI/ISO 11137. For unique applications that require modification or customization, contact our customer service department. Customer-generated designs, sizes, packaging and other options Ð such as connectors, heat-sealed ends or alternate bottle materials Ð are available on request.
- Designed for single use
- Unobstructed fluid path
- Extremely low levels of extractables
- Easily used with sterile connecting devices and thermal tubing sealers
- Available in sizes from 60 mL to 2 liter
- Sterility Assurance Level (SAL) of 10-6 per ANSI/AAMI/ISO 11137
- System delivered double-bagged
- Biopharmaceutical
- Fed-batch bioprocess
- Sample collection
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At Liquidyne, we prioritize our commitment to quality and consistency. In 2017 we achieved ISO 9001:2015 Quality Management System certification to ensure we can repeatedly deliver consistently high-quality products and solutions. Being ISO 9001:2015 QMS Certified by Orion Registrar, Inc, together with our USP Class VI Testing, ASME Bioprocessing Equipment (BPE), and EHEDG certification guarantee, we have the methodologies to assure quality. We will quickly and accurately rectify any issues if any of our products are ever in non-conformance.
