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The effect of temperature exposure during shipment on a commercially available demineralized bone matrix putty.
Cell Tissue Bank 2016; 17(4):677-687CT

Abstract

During August and September of 2013, temperature data loggers were shipped to and from an AATB accredited and FDA registered allograft tissue processing facility in Belgrade, MT (Bacterin International, Inc.) to five warm climate cities (Dallas, TX, El Paso, TX, New Orleans, LA, Phoenix, AZ, and Tampa, FL). Shipping data acquired from 72 independent shipments were analyzed to generate an assessment of temperature exposure, shipment times, and shipping event durations experienced during routine distribution. Overall the packages experienced an average temperature of 26.2 ± 2.3 °C which mirrored the average external ambient temperature of 25.8 ± 3.0 °C. However, temperature spikes above 40 °C were frequently observed. The data from the model shipments were extrapolated to provide a worst-case high temperature spike of 52.9 °C for 12 h and 14 min. Multiple lots of a commercially available demineralized bone matrix (DBM) putty (OsteoSelect® DBM Putty) were subjected to continuous heating at 50 °C, to multiple worst-case temperature spikes, and to multiple freeze-thaw cycles to assess the effects of these temperature extremes on the handling and osteoinductivity of the allograft tissue. Five weeks of continuous exposure to 50 °C and 12 simulated worst-case one-way shipments did not adversely affect the handling characteristics or the in vivo osteoinductivity of the product.

Authors+Show Affiliations

DCI Donor Services Tissue Bank, 1714 Hayes Street, Nashville, TN, 37203, USA.Bacterin International, Inc., a wholly owned subsidiary of Xtant Medical Holdings, Inc., 664 Cruiser Lane, Belgrade, MT, 59714, USA.Bacterin International, Inc., a wholly owned subsidiary of Xtant Medical Holdings, Inc., 664 Cruiser Lane, Belgrade, MT, 59714, USA.Bacterin International, Inc., a wholly owned subsidiary of Xtant Medical Holdings, Inc., 664 Cruiser Lane, Belgrade, MT, 59714, USA.Bacterin International, Inc., a wholly owned subsidiary of Xtant Medical Holdings, Inc., 664 Cruiser Lane, Belgrade, MT, 59714, USA. gjuda@xtantmedical.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27562800

Citation

Schallenberger, Mark, et al. "The Effect of Temperature Exposure During Shipment On a Commercially Available Demineralized Bone Matrix Putty." Cell and Tissue Banking, vol. 17, no. 4, 2016, pp. 677-687.
Schallenberger M, Lovick H, Locke J, et al. The effect of temperature exposure during shipment on a commercially available demineralized bone matrix putty. Cell Tissue Bank. 2016;17(4):677-687.
Schallenberger, M., Lovick, H., Locke, J., Meyer, T., & Juda, G. (2016). The effect of temperature exposure during shipment on a commercially available demineralized bone matrix putty. Cell and Tissue Banking, 17(4), pp. 677-687.
Schallenberger M, et al. The Effect of Temperature Exposure During Shipment On a Commercially Available Demineralized Bone Matrix Putty. Cell Tissue Bank. 2016;17(4):677-687. PubMed PMID: 27562800.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of temperature exposure during shipment on a commercially available demineralized bone matrix putty. AU - Schallenberger,Mark, AU - Lovick,Helena, AU - Locke,Jalane, AU - Meyer,Todd, AU - Juda,Gregory, Y1 - 2016/08/25/ PY - 2015/09/29/received PY - 2016/08/13/accepted PY - 2016/8/27/pubmed PY - 2017/2/9/medline PY - 2016/8/27/entrez KW - Allograft tissue KW - Demineralized bone matrix KW - Osteoinductivity KW - Shipping validation KW - Temperature effects SP - 677 EP - 687 JF - Cell and tissue banking JO - Cell Tissue Bank VL - 17 IS - 4 N2 - During August and September of 2013, temperature data loggers were shipped to and from an AATB accredited and FDA registered allograft tissue processing facility in Belgrade, MT (Bacterin International, Inc.) to five warm climate cities (Dallas, TX, El Paso, TX, New Orleans, LA, Phoenix, AZ, and Tampa, FL). Shipping data acquired from 72 independent shipments were analyzed to generate an assessment of temperature exposure, shipment times, and shipping event durations experienced during routine distribution. Overall the packages experienced an average temperature of 26.2 ± 2.3 °C which mirrored the average external ambient temperature of 25.8 ± 3.0 °C. However, temperature spikes above 40 °C were frequently observed. The data from the model shipments were extrapolated to provide a worst-case high temperature spike of 52.9 °C for 12 h and 14 min. Multiple lots of a commercially available demineralized bone matrix (DBM) putty (OsteoSelect® DBM Putty) were subjected to continuous heating at 50 °C, to multiple worst-case temperature spikes, and to multiple freeze-thaw cycles to assess the effects of these temperature extremes on the handling and osteoinductivity of the allograft tissue. Five weeks of continuous exposure to 50 °C and 12 simulated worst-case one-way shipments did not adversely affect the handling characteristics or the in vivo osteoinductivity of the product. SN - 1573-6814 UR - https://www.unboundmedicine.com/medline/citation/27562800/The_effect_of_temperature_exposure_during_shipment_on_a_commercially_available_demineralized_bone_matrix_putty L2 - https://doi.org/10.1007/s10561-016-9578-1 DB - PRIME DP - Unbound Medicine ER -