Product Overview

UPDATE (Mar 2018):

Beginning in late March, our 100 ml (P/N W50-100), 500 ml (P/N W50-500) and 1000 ml (P/N W50-1000) LAL Reagent Water will be produced by a qualified contract manufacturer in addition to in-house manufacturing. This change is being made in order to ensure availability and maintain security of supply for these products. The contract manufacturer has been qualified by Lonza internal procedures and vendor audit. The lots sourced from the contract manufacturer will meet the release criterion that has been previously established for LAL Reagent Water produced in-house. We are therefore confident that this change will have no impact to the quality of the product.

UPDATE (FEB 2015):

Beginning late February 2015, the following changes will be made to our 100mL (P/NW50-100) and 500mL (P/N W50-500) LAL Reagent Water:

   
• Container/Closure - The 100mL (P/N W50-100) and   500mL (P/N W50-500) containers will be   changed from a glass bottle with a plastic cap to a plastic bottle with a   plastic cap.  The container/closure is   consistent with the packaging used for the 1 liter LAL Reagent Water product (P/N   W50-1000).  The type of plastic used for   the bottles is PETG - a type 1 recyclable plastic.  The type of plastic used for the cap is HDPE   - a type 2 recyclable plastic. A stability study, on file at the Lonza   Walkersville site, was conducted prior to the change to ensure no adverse   effect would result from the container/closure change.   
• Positive   Product Control (PPC) – Harmonization of the PPC specification across Lonza LAL   Reagent Water products will occur. For the W50-100 and W50-500 products, the   specification will be tightened from 50-150% to 75-150%.   

Product Overview:

Lonza's LAL Reagent Water (LRW) is manufactured at theWalkersville, MD, USA facility and is tested to purity requirements beyond thatof Water for Injection (WFI) and most other non-pyrogenic water products. Thepurified water system used to produce the LAL Reagent Water is routinelymonitored and tested to meet all USP requirements for WFI. Lonza LAL ReagentWater is tested to ensure the endotoxin levels are < 0.005 EU/mL, which isfifty times lower than the USP/EP WFI requirement of < 0.250 EU/mL. Additionally,Lonza has a Positive Product Control (PPC) requirement for the LAL ReagentWater of 75-150%, which is more stringent than the 50-200% PPC recovery allowedby the Pharmacopeia. This ensures the absence of any inhibitory or enhancingproperties in the LAL Reagent Water.Use Lonza’s LAL Reagent Water for preparation of any controlor sample when performing the endotoxin detection test. Lonza’s water is testedto be endotoxin free and compatible with your endotoxin assay. LAL ReagentWater is equivalent to Water for Bacterial Endotoxins Test (BET).