Clean-Room Packed Sampling Assemblies for WFI
aSURE® water for injection (WFI) Samplers are a simple, single-use solution for achieving a contaminant-free sample from a WFI use point. The assemblies come double bagged in an easy-peel, low permeability, medical-grade pouch and are available gamma irradiated to ensure microbial control. aSURE WFI samplers can also be sterilized in an autoclave.
All assembly is conducted in a state-of-the-art ISO Class 7 clean-room.
Patent-Pending aSURE® Fused Gasket Technology!
TBL’s patent-pending aSURE® Fitting with a fused gasket creates a new paradigm in aseptic, sanitary Tri-Clamp connectivity. It eliminates the need for hand contact with the gasket, eliminates misalignment and the possibility of using the wrong gasket material or mistakenly not including a gasket.
Low TOC Materials
The materials in aSURE® WFI sampers were selected in part because they do not contribute materially to TOC levels. In addition, a representative sample of all fluid-contact materials have been tested in accordance with USP Class VI, ISO 10993, and FDA requirements. Parts are animal-derived-ingredient free (ADIF), RoHS, REACH, and California Proposition 65 compliant.
Autoclave |
Gamma Irradiation |
Ethylene Oxide (ETO) |
USP Class VI |
ISO 10993 |
Meets FDA Requirements |
Animal Derived Component Free (ADCF) |
REACH, RoHS, California Prop. 65 |
Part Number | Description |
---|---|
AS-LH04.3.1299-18 | aSURE™ WFI Sampler Hose Mini (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 18″ Length, Double Bagged/ Gamma Treated |
AS-LH04.3.1299-36 | aSURE™ WFI Sampler Hose Mini (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 36″ Length, Double Bagged/ Gamma Treated |
AS-LH04.3.2499-18 | aSURE™ WFI Sampler Hose 1-1/2″ (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 18″ Length, Double Bagged/ Gamma Treated |
AS-LH04.3.2499-36 | aSURE™ WFI Sampler Hose 1-1/2″ (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 36″ Length, Double Bagged/ Gamma Treated |
ASNG-LH04.3.1299-18 | aSURE™ WFI Sampler Hose Mini (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 18″ Length, Double Bagged |
ASNG-LH04.3.1299-36 | aSURE™ WFI Sampler Hose Mini (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 36″ Length, Double Bagged |
ASNG-LH04.3.2499-18 | aSURE™ WFI Sampler Hose 1-1/2″ (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 18″ Length, Double Bagged |
ASNG-LH04.3.1299-18 | aSURE™ WFI Sampler Hose 1-1/2″ (TC) Connection W/ Size #24 Pharm-A-Clear LH Tube X 36″ Length, Double Bagged |
Specifications are subject to change without notice.