Tissue License

HealthLink Europe adheres to the European Tissue Bank Standards and regulations established by the Medical Device Directive in the storage and distribution of tissue. Our certified facility provides temperature monitored storage based on the products specifications requirements and the storage conditions for the various types of tissue.

Our monitored warehouse facilities have a multitude of storage environments based on the product needs equipped with alarms and back up controls. Each temperature monitored space is inspected daily and our monitoring system allows a web portal to view the temperature controls throughout our accredited facility. Our rigorous quality system understands the controls needed to support specific handling requirements.

Freeze-dried tissues do not require any form of temperature maintenance during transport and can be stored without the need for refrigeration or freezing for a period of up to five years. While the recommended storage temperature for this type of allograft is generally between 15ºC and 30ºC, the most important consideration is package integrity. Graft packaging should be checked at the time of receipt to ensure all seals are intact and that no damage to the packaging materials has occurred. HealthLink preforms an inspection upon receipt of all product received within our facility.

Tissue that requires refrigeration should not be frozen, nor should it reach temperatures outside the range of 1ºC to 10ºC for storage. The shelf life of refrigerated tissue is specific to each graft type and should be reviewed by examining the individual package label for the graft expiration date. Graft packaging should be checked at the time of receipt to ensure all seals are intact and that no damage to the packaging materials has occurred.

Frozen tissue is aseptically processed and then frozen to -80ºC for storage and distribution. Tissue should be maintained in the range of -80ºC to -40ºC, but can be stored above -40ºC and below -20ºC for a period of six months. Graft packaging should be checked at the time of receipt to ensure all the seals are intact and that no damage to the packaging materials has occurred.

Specific shipping containers can be sourced based on the transporting requirements.  Each of the containers used for transporting tissue have been validated for temperature control and durability. The validations include calculation of sublimation rates, which are used to determine the expiration time of the transport container based on the amount of dry ice or gel packs placed in the container. These transport expiration times are posted on the shipping label on the outside of the container.

HealthLink has the ability to include a temperature logger within each shipment to view the temperature excursions during transportation from our facility to the end destination. Our experience with cold chain shipments and understanding of the tissue handling requirements has allowed us to support multiple types of products. This validated certifications is only offered in our European platform and upon accreditation by the AATB our North American location will be able to offer this service pending approval.