LexaMed now offers Total Organic Carbon (TOC) analysis compliant with United States Pharmacopeia (USP) Chapter . 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.
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. Read more….
LexaMed ISO 13485 certified laboratories provide quality services in routine microbiology and chemistry testing, specific project testing, client R&D, sterilization, and packaging. Dedicated laboratory space and personnel are available for the execution of custom R&D protocols.
LexaMed manufactures “Growth-Chek” Microbial Suspensions that are derived from cultures traceable to a recognized culture collection identified in USP. They are specially prepared for simplifying the performance of Quality Control measures for growth media.
LexaMed offers consulting services in all aspects of the pharmaceutical, medical device and biotechnology industries. We integrate our subject matter experts into problem-solving teams to provide the most cost-effective and practical solutions to our clients’ specific needs.
LexaMed offers consulting services to the pharmaceutical, medical device and biotechnology industries, provides microbiology and chemistry testing in our corporate laboratories, and manufactures microbial suspensions. LexaMed compliments its consulting and validation services, laboratory operations and microbial suspension product line with additional integrated services in quality management systems, regulatory assistance, auditing, testing programs for sterilization of packaging systems, cleaning and sterilization validation of reusable devices, client research & development, environmental monitoring, container closure integrity testing, and training and seminars. Please contact us to discuss your specific requirements and determine how our staff can best support you and your operation.