About FUJIFILM Wako
FUJIFILM Wako Chemicals U.S.A. Corporation (FUJIFILM Wako) is recognized around the world as a trusted supplier of pure chemicals and laboratory reagents. After establishing a sales office in Dallas, Texas, in 1981, we grew significantly in the U.S. and in 1989, relocated our corporate headquarters and manufacturing facility to Richmond, Virginia. In 2012, we culminated three decades of research and development by introducing our PYROSTAR™ ES-F series of endotoxin detection reagents, consumables and instrumentation to the global market. As a licensed facility, FUJIFILM Wako is committed to ensuring that our production site and products comply with the strictest quality standards set forth by the FDA and that the processes used to prepare our products adhere strictly to current Good Manufacturing Practices (cGMPs).
Being a principle manufacturer of Limulus Amoebocyte Lysate, FUJIFILM Wako is committed to the sustainability of the Atlantic horseshoe crab (Limulus polyphemus) population and voluntarily follows a set of best practices that involve careful handling and selection of healthy, viable animals. Our bleeding procedures, which take place at our facility in Cape Charles, VA. are conducted with the utmost diligence to prevent any injury to the donor crabs, and our fishermen always return them to the same waters from which they were collected. FUJIFILM Wako cooperates with the U.S. Fish and Wildlife Service to tag and monitor horseshoe crabs as part of an ongoing conservation effort.
FUJIFILM Wako LAL Products
FUJIFILM Wako provides a suite of complementary products designed to offer a complete solution for your endotoxin testing needs and which support perform each of the three endotoxin detection assays: the gel clot assay, the kinetic turbidimetric assay (KTA) and the kinetic chromogenic assay (KCA).
The PYROSTAR™ ES-F series of reagents, our flagship products, are endotoxin-specific and specially formulated to be unreactive to (1,3)-ß-D-glucan. In addition, these products are dual-purpose, meaning they are formulated to be used as either a gel clot or kinetic turbidimetric assay. They are available in a single-test or multi-test configuration. All reagent kits are matched with a specific Control Standard Endotoxin (CSE) and work well with samples that have color or with samples that present difficulties in quantification by the KCA.
The Limulus Color KY Series are quantitative kinetic chromogenic assays (KCA) that are endotoxin-specific and unreactive to (1,3)-ß-D-glucan. This series includes both a multi-test kit and a single-test kit, which utilize a synthetic substrate that produces a yellow color to detect endotoxin with high sensitivity. All reagent kits are matched with a Control Standard Endotoxin (CSE) and work well with samples that are very turbid or show difficulty in quantification by the kinetic turbidimetric assay (KTA).
The Limulus PS Single Test contains endotoxin-specific single-test vials and an affinity resin suspension called PyroSep™, which is designed to overcome any product interference by adsorbing potential endotoxin in samples while washing away the inhibitory components.
Software and Instrumentation
FUJIFILM Wako also provides analysis systems with software that is user friendly and capable of performing all methodologies for LAL testing. The Toximaster® QC8 software supports data processing based on the protocols complying with three types of pharmacopeia (USP/EP/JP) for bacterial endotoxin testing. This software is compliant with FDA 21 CFR Part 11 ERES (electronic records/electronic signature), which requires the proper information from all parties involved in the testing of the sample. Toximaster® QC8 offers excellent audit trail capabilities, can provide statistical processing of means and standard deviations, and has robust data processing functions. These data processing functions can be performed by defining sample types such as standards, controls and test samples.
The Toxinometer® ET-7000 is a computer-operated kinetic incubating tube reader, designed to be exceptionally user-friendly. Our state-of-the-art expansion modules can be connected to allow for endotoxin testing in a wide range of fields and sample quantities. The Toxinometer® ET-7000 can perform all LAL testing methodologies (gel clot, kinetic turbidimetric and kinetic chromogenic assays). The instrument has 16 wells for single-test configuration in order to easily detect erroneous readings or contamination associated with each well. The kinetic incubating tube reader has uniformity temperature settings of 30°C and 37°C.
The BioTek ELx808 microplate reader provides the flexibility to manipulate and analyze your data. This multi-channel reader continues BioTek’s tradition of offering the strictest specifications of any microplate reader that ensure both accurate and repeatable results. The ELx808 offers a superior 4-zone™ incubator, providing excellent stability for temperature-sensitive assays such as endotoxin analysis and long-term bacterial and yeast growth studies. FUJIFILM Wako now offers this highly reliable instrument with a convenient laptop and software package specifically dedicated to LAL testing.
Endotoxin Free Accessories
FUJIFILM Wako offers a premiere collection of endotoxin-free accessories including pipette tips, microplates, test tubes, caps and LAL Reagent Water designed for worry-free endotoxin testing.
Endotoxin Test Related Products
Our Endotoxin Test-Related Products are additional specialty kits that assist with the successful completion of bacterial endotoxin tests and include control standard endotoxin, endotoxin challenge vials, LPS for endotoxin indicators, endotoxin specific buffer and endotoxin extracting solution.