Problem: The issue of sample security in laboratories is becoming a prominent topic, especially with the abundance of biobanks opening up across the globe. In an ideal world, there would be industry guidelines to standardize, and in some cases even regulate, the storage of samples in all laboratories. However, in reality, storage is far from standardized.
The need for sample tracking and security is rising, but many laboratories do not have the funding or resources to update their processes with advanced sample management systems. Most laboratory freezers are opened and closed manually, which does not provide any level of sample security.
21 CFR Part 11 compliance, including sample audit trails, is an important requirement in pharmaceutical applications. In many government labs, biosafety is a critical issue requiring sophisticated storage access controls. Some of these concerns stem from the anthrax incident in 2001, after which investigators determined the chain of custody documentation was incomplete. In an effort to help prevent future incidents, Congress introduced the Select Agent Program and Biosafety Improvement Act of 2009 to help develop standards for laboratory biosafety. But even this bill does not provide universal standardization, and it does not cover all laboratories.
The bottom line is that without standards in place, most laboratory samples are not secure and sample integrity is not safeguarded.
Solution: Hamilton Storage Technologies has developed an automated sample management system that provides sample security, audit trails and complete chain of custody documentation. The Sample Access Manager (SAM) is the only -80°C automated storage module on the market equipped with 21 CFR Part 11-compliant software that provides a laboratory with the ability to manage and track samples. This is achieved by supplying access control functions and detailed reports that document the security of a sample.
In a manual freezer, samples can be accessed by anyone in the laboratory. With SAM, user rights and groups can be set up to limit access to specified libraries. Password protection ensures that a user can only access samples for which he/she is authorized. The system includes electronic signature capability for 21 CFR Part 11 applications. SAM maintains a complete sample log providing information such as who took out the sample, how long it was out and how many times it was taken out. These reports help a laboratory properly manage chain of custody.
Hamilton’s SAM is a compact, robust and localized storage system for secure sample management of plates and tubes. The SAM offers reliable automation, multiple sample type capability, cherry-picking, sample tracking and easy-to-use software. The SAM is environmentally controlled with a temperature range of -55°C to -80°C in the -80°C platform or +20°C to -40°C in the -20°C platform, which allows for storage of both compounds and biological samples. The SAM is useful for a wide range of biobanking, forensics, genetic analysis and drug discovery applications
For more information, visit www.hamilton-storage.com.