Standards Updates - October 23, 2017

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AATB Guidance Document No. 9 Is Now Available​

Bulletin 17-11

October 23, 2017

The Board of Governors acted on a recommendation from the Standards Committee and approved Guidance Document No. 9: Qualification of Packaging and Validation of Shipping/Transport Procedures.

This guidance was developed to address requirements for packaging used to protect tissue stored and transported in various states such as refrigerated, frozen, lyophilized, dehydrated, cryopreserved, or preserved by another suitable method. This guidance document is advisory in nature only.

Due to frequent questions regarding qualification and validation, subject matter experts discussed these requirements and, via this document, are recommending guidance for Qualification of Packaging and Validation of Shipping/Transport Procedures.

If you have questions please contact the AATB Executive Office at aatb@aatb.org.

The AATB recognizes the efforts of the following individuals who generously donated their time and expertise to creating this guidance document:

Marie Tkacik (Lead editor) - Beacon Converters

Jesse Adawag - Advanced Biologics, LLC

Scott A. Brubaker

Grace Bolton - LifeLink

Jackie Daly Johnson - Beacon Converters

Ellen Demont - LifeLink

Kevin Engemann - AxoGen Corporation

Agustin Carrillo Garcia - Novoinjertos

Joseph Hamby - Cryolife, Inc.

Kathleen Heath - GenCure

Matt Jenkins - Medtronic

Shanaz Kahn - Vivex, Powered by UMTB

Ann Kelly - Exactech, Inc

Alison Ling - MTF

Tom Moore - Biomet

Uzair Rajput - LifeNet Health

Kenneth Ying - MNX

Michelle Lewis - AATB liaison

Jason LoVerdi - AATB Standards Committee liaison

Special thank you to Grant Cleavenger for developing the Figures used in the guidance document.