Sample Management Services and Precautionary Practices required

to maintain functional & identity integrity of the specimens associated with each service:

A KEY FACTOR FOR THE SECURITY AND INTEGRITY OF BIOSPECIMENS AND EXPERIMENTAL DATA

To assist in getting meaningful outcome of any study, KTI lays high emphasis on the maintenance of functional, physical and identity integrity of bio-specimens during all phases of bio-repository operation.

Sample Management

process must start at the time and method of sample procurement. During transport care must be taken to:

• control the temperature of the samples,

• safeguard their container from breakage and

• Take measures against any labeling compromise

The most important component of receiving & accepting biological reagents & specimen shipments at KTI is, thus, Validating the Integrity of Specimens.

Storage temperature of specimens is maintained during all shipment processes.

All incoming bio-specimen shipments

by ground or air transport must be packed and shipped in full compliance with all requirements for the shipment of dangerous goods, infectious substances and biological products & may also include temperature recording devices.

KTI coordinates with its customers and assist them if needed, to ensure that such packaging requirements are fully adopted before handing the package to a courier service.

During Transit

During transit, KTI tracks samples and stays ready to receive and log them in.

At KTI facility

Each incoming package of reagents undergoes an external visual inspection for any physical damage. The package is opened and the contents are checked for vial/container integrity and reagent condition. The contents of each shipment is audited to validate the material received for any discrepancies, missing vials or incomplete reagent product information. The inspection results of each shipment are recorded as a part of log-in process to include:

► Date and time received

► Carrier,

► Shipment temperature upon arrival,

► Air-way bill number,

► Number of vials of each reagent,

► Assigned catalog (ID) numbers and

► Condition of reagents upon arrival.

Client is notified within two hours or by the next business day of all reagent shipments that arrive at the repository. All receipt
information about the reagents and their storage locations are entered into the inventory database and communicated to the client.

TRANSPORT OF BIO-SPECIMENS IN THEIR FREEZERS

For new projects where clients want to have their freezers with their bio-specimens be transferred to KamTek,

• we work with third party vendor with a track record of such transport for KamTek.

• Freezer temperature is recorded during the transport process and

• reports are generated for the client.

In addition, infra-structure arrangements are made ahead of time to make sure those freezers are up and running upon arrival at the facility and are ready to be monitored.

For Ultra freezers,

KTI makes sure that the electrical connection requirements are fully addressed, i.e. we have electric lines and receiving plugs of correct voltage and configuration for the coming freezers.

For LN2 Freezers,

KTI make sure there are LN2 feeding lines are also available for newly arriving freezers and our vendor is ready to program if needed to set up the feeding control unit for appropriate level of LN2, consequently appropriate temperature.

The underlying objective is that the specimens do not undergo substantial temperature change duringthe transport and re-installation process at KTI.

In addition, appropriate Rees CMS probes are acquired and have Rees technician available to install them and connect them to data receiving sensors.