AATB Guidance Document No. 9 Is Now Available
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 firstname.lastname@example.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.