PYROSTAR® Bacterial Endotoxin Testing
Endotoxin testing is a vital, regulatory mandated assay for all injectable or implantable products. PYROSTAR® is a range of instruments, consumables & reagents for testing, using the established & trusted Limulus Amebocyte Lysate (LAL) method.
Endotoxin testing will ensure all injectable or implantable products are free from bacterial endotoxins, which have the potential to cause damaging and sometimes fatal fevers. PYROSTAR® is a range of instruments, consumables and reagents manufactured by FUJIFILM WAKO for Bacterial endotoxin testing, using the long established and trusted Limulus Amebocyte Lysate (LAL) method.
Endotoxin testing is a vital, regulatory mandated assay for all injectable or implantable products. Using the PYROSTAR range of products to perform your endotoxin testing in house gives you full control over one of the most important aspects of your quality control.
When used in conjunction with the corresponding kits, the ET-7000 toxinometer allows for endotoxin testing by 3 methods, each utilising the Limulus Amebocyte Lysate (LAL) clotting principle:
Gel Clot Assay (GCA)
Kinetic Turbidimetric Assay (KTA)
Kinetic Colorimetric Assay (KCA)
Alpha laboratories can supply all the reagents, accessories, consumable and equipment necessary for this testing, providing you a one stop shop for all your endotoxin testing needs.
The PYROSTAR® range is perfect for those looking to take control of their endotoxin testing by moving it in house. This, and the advanced features of the PYROSTAR® range, provides many advantages over outsourcing:
Greater Control– You control every aspect of your testing process allowing you to ensure that it is carried out to your standards
Quicker Results – With samples tested in-house results are available as soon as the assay finishes, no more waiting for samples and results from external laboratories
Improved Troubleshooting – Fix issues with testing and products as soon as they occur, don’t rely on other laboratories to alert you to or fix problems. Track product results over time to identify potential problems before they affect quality.
Testing that Grows with You – With the modular nature of the ET-7000 Toxinometer your testing capabilities can grow as you need them. Each testing module can process 16 per run with up to 11 modules connected to a single PC. This allows you to test up to 176 samples per run for each PC.
Testing that Fits You – PYROSTAR® assays are available in different formats and pack sizes at a range of specificities allowing you to tailor your testing and workflow to your needs.
FDA Approved – The GCA and KTA endotoxin testing methods have been approved for use by the FDA when used with the Part 11 software, PC and testing module set.
PYROSTAR ® Color KY Series endotoxin testing kits use the Kinetic Colorimetric Assay (KCA) method.
PYROSTAR ® ES-F Series endotoxin testing kits use the Kinetic Turbidimetric Assay (KTA) and Gel Clot Assay (GCA) methods.
Pyrosep Kits and Accessories
PYROSTAR® kits and accessories using the Pyrosep™ method reduce sample interference and allow testing of previously unusable samples.