InVitroCare Incorporated Information

Our IVC Media series is designed to support embryo growth at each stage of development providing maximum flexibility in managing the assisted reproductive process. InVitroCare® has almost twenty years experience in providing consistently high quality ART products to a global customer base. All of our products are manufactured in FDA registered facilities in full compliance with all cGMP and ISO 9002 standards. InVitroCare® is committed to provide customers with products and services meeting all specifications and fulfilling customers' needs and expectations. The highest priority and emphasis is placed on the integrity of our products, their safe manufacture and distribution and the compliance with all relevant regulations. To achieve these goals, InVitroCare® media is manufactured in facilities which operate local quality management systems that comply with internal policies as well as with national and international standards (e.g. ISO) and regulations (e.g. cGMP, PIC, HACCP). The fundamental elements of these systems are continuously undergoing improvement. They include:Comprehensive validations processesImmediately available technical support for customersComplete documentation and traceability for all manufactured lotsResponsive Customer ServiceMANUFACTURINGLiquid Media - Membrane filtration procedures used for the sterile filtration of InVitroCare® media are routinely validated. Filtration membranes are chosen from approved vendors and are sized to exclude particles greater that 0.2 microns. Membrane material must pass a microbial challenge test of being able to absolutely retain at least 10 7 organisms of Brevundimonus diminuta per square cm of filter area. Each sterilizing filter unit is integrity tested by the manufacturer and provided with a Certificate of Quality. Integrity testing of each filter, when positioned in its appropriate housing, is performed both before product filtration and after filtration. An automated forward flow integrity tester, Palltronic, is used to perform filter integrity testing. Redundant 0.2 Micron filters are used in series to assure that the microbial challenge hitting the final sterilizing filter does not exceed the validated retention capabilities of the filter. Chemicals - All chemicals used in InVitroCare® media products conform to at least ACS, USP, NF and other International Pharmacopeia standards where appropriate. Certificates are obtained from vendors. Samples of components are tested for endotoxin, efficacy and toxicity as appropriate. Human Source Raw Materials - HSA used in InVitroCare® products is therapeutic grade. Parent HSA is derived from blood from CBER licensed Blood Banks. All donors used to obtain the Human Serum Albumin were individually tested and found to be non-reactive for HbsAg, HCV and antibodies to HIV-1 and HIV-2 by approved testing methods. Source material is also screened by questionnaire at the donor level for risk factors associated with Creutzfeldt-Jakob Disease (CJD). Water - All InVitroCare® media products are formulated using water which is aseptically processed from a validated system that meets current USP specifications. The method for the production includes: ultra filtration, reverse osmosis, deionization, and sterile filtration. The system is validated and monitored daily for chemical quality, bioburden and endotoxin. It is also routinely shutdown for cleaning and preventative maintenance annually. QUALITY CONTROL