The AlloSource Way
Transcription
The AlloSource Way
The AlloSource Way AlloSource makes the commitment to never compromise integrity for gain and expediency. Doing things “The AlloSource Way” means driving our decisions from a philosophy of respecting our donors, understanding the needs of our doctors and providing the best tissue for our recipients. Our filter of integrity means our commitment is working with our customers to doing it right, not just getting it done. AlloSource 6278 S Troy Cir Centennial, CO 80111 main fax 720. 873. 0213 720 .873. 0212 allosource.org © AlloSource 2012 M1S0946.00 09/2012 1 T HE A L L OSO UR CE WAY 2 DONAT ION •An unwavering focus on integrity in all we do •The only tissue processor and distributor founded by Organ Procurement Organizations (OPOs) for the purpose of supporting local communities •Devoted, committed, humane employees •Most tissue processed at AlloSource received from OPOs •Knowledgeable, technicallyastute processors steadfast in their drive to produce quality tissue •Strict donor criteria developed by renowned AlloSource Medical Advisory Board •A deep respect for our donors, our customers and our recipients •Stringent screening procedures include: -- A respectful and in-depth medical social history -- Extensive serology testing •A non-profit organization that works for the community – not the shareholders FROM DONOR THE ALLOSOURCE WAY 3 IN IT IAL T IS S U E P R O C E S S ING •Initial physical inspection and debridement to remove visibly defective tissue •Rigorous tissue inspection to eliminate substandard tissue and ensure suitability of tissue to be processed •Only Sterile or USP 24 Grade Water used in processing •ISO Class 5 to 7 clean rooms •Continuous environmental monitoring to detect potential contaminants -- Physical assessment DONATION INITIAL TISSUE PROCESSING 4 P R E PAR AT IO N FO R AlloTru e™ C L E A N S IN G PROCESS •AlloTrue technology’s customized cleansing and reagent administration based on specific tissue type and weight 5 TH E A l l oTr ue™ C LEA N SI N G P R OC ESS P OST TR EATM EN T/ EX TR A C TI ON •Reduces bioburden of the processed tissue •Utilizes low dose (10-13 kGy), low temperature irradiation •Utilizes a combination of treatments of antibiotics, alcohol, peroxide (cut tissue only) and multiple water rinses •Irradiation process gives tissue a Sterility Assurance Level (SAL) of 10-6 •Accurate weights obtained through sophisticated centrifugation process •Deep penetrating cleansing with minimal tissue manipulation results in microbial inactivation •AlloTrue’s technology prevents overexposure to solutions and temperature • The process includes: •Tissue aseptically placed in air tight ultrasonic canisters, thereby reducing the risk of tissue contamination PREPARATION FOR ALLOTRUE CUSTOM CLEANING 6 -- Sonication for loosening of bloods and lipids -- Rotation for even and dynamic distribution of reagents and rinses -- Temperature control to reduce the risk of tissue damage THE ALLOTRUE CLEANSING PROCESS •ISO 11137 Method 2B used for sterility validation •Low dose radiation (15kGy) does not compromise the mechanical integrity of the allograft tissue1 •Full water immersion extraction taken, as opposed to batch swab, to increase accuracy of microbial presence reading POST TREATMENT/ EXTRACTION TO RECIPIENT K.C. McGivray et al. Cell Tissue Bank. DOI 10.1007/510561-010—9170-2.2009 1