February 19, 2016- LexaMed now offers Total Organic Carbon (TOC) analysis compliant with United States Pharmacopeia (USP) Chapter <643>. TOC provides a quantitative measurement of carbon dissolved in water or other solvents. Pharmaceutical and medical device manufacturers using purified water need to ensure the water entering their facility and produced in their facility contains safe levels of organic compounds. Purified Water must meet the requirements of the USP for TOC content along with Conductivity and Bioburden Count.
February 18, 2016- LexaMed has expanded its Filter Integrity Test offerings by now offering Bacterial Retention Testing as recommended in the Food and Drug Administration (FDA) Guidance on Sterile Drug Products Produced by Aseptic Processing. When filtration is used as a method for sterilizing drug product solutions, the filter must be validated to demonstrate that it can reproducibly remove viable organisms from the process and produce a sterile product. Testing is conducted using scaled down processing parameters with direct inoculation of a challenge organism into the drug product to provide an assessment of the effect of the drug product on the filter matrix. In the case of products with inherent bactericidal activity appropriate alternative methodology is employed.