RESUMEN
OBJECTIVE: To verify the technics of inactivating/removing virus in collagen sponge derived from bovine Achilles tendon. METHODS: Possible pathogen species were determined according to the raw material of bovine Achilles tendon used in production, then vesicular stomatitis virus (VSV), theiler's mouse encephalomyelitis virus (TEMV), pseudorabies virus (PRV), and simian vacuolating virus 40 (SV40) were selected as indicator virus. Virus suspension was prepared in accordance with Technical Standard for Disinfection. 60Co radiation 25 kGy of collagen sponge was determined as inactivating/removing virus process according to the analysis of the manufacture process, the virus inactivation/removal effect was verified by the measurement of median tissue culture infective dose (TCID50) and showed by virus reduction factor (sample average values of numerical difference before and after processing). RESULTS: Reduction factors of VSV, TEMV, PRV, and SV40 after 60Co radiation 25 kGy were 5.646, 4.792, 5.042, and 5.292 logTCID50/0.1 mL (logs), respectively. Reduction factor of each indicator virus was greater than 4 logs, showing that 60Co irradiation 25 kGy can effectively inactivate and remove viruses. CONCLUSION: 60Co radiation 25 kGy of collagen sponge derived from bovine Achilles tendon can be used as the technics of inactivating/removing virus during the preparation process of collagen sponge to guarantee the safety of the product.
Asunto(s)
Radioisótopos de Cobalto , Colágeno , Esterilización/métodos , Inactivación de Virus/efectos de la radiación , Virus/efectos de la radiación , Tendón Calcáneo/química , Tendón Calcáneo/virología , Animales , Bovinos , Línea Celular , Seguridad de Productos para el Consumidor , Equipos y Suministros de Hospitales , Esponja de Gelatina Absorbible , Herpesvirus Suido 1/efectos de la radiación , Virus Maus Elberfeld/efectos de la radiación , Virus 40 de los Simios/efectos de la radiación , Vesiculovirus/efectos de la radiaciónRESUMEN
The risk of transmitting human pathogenic viruses via allogeneic musculoskeletal tissue transplants is a problem requiring effective inactivation procedures. Virus safety of bone transplants was achieved using peracetic acid (PAA)-ethanol sterilisation. Proteins are known to have an adverse effect on the virus-inactivating capacity of PAA. Therefore we investigated virus inactivation by PAA in collagenous tissues. Achilles tendon, skin and cartilage were cut into small pieces, lyophilised and contaminated with pseudorabies virus (PRV) or porcine parvovirus (PPV). The inactivating capacity of PAA-ethanol was investigated by determining virus titres in the supernatant or the tissue pellet at different time-points. In all virus-contaminated tissue samples treatment for 10 min with PAA-ethanol resulted in titre reductions by a factor of >10(3). PRV was rapidly inactivated below the detection limit (< or =2.8 x 10(1) TCID(50)/ml). After 240 min a reduction by a factor of >10(4) was obtained for PPV in all samples, but a residual infectivity remained. Collagenous proteins of Achilles tendon, skin and cartilage had no adverse effect on the virus-inactivating capacity of PAA. PAA-ethanol used in the production process at the Charité tissue bank can therefore be recommended for treatment of non-osseous musculoskeletal tissues.