AutoLys Tubes Instructions for Use (IFU)

Transparent microcentrifuge tube with orange screw cap, shown disassembled with insert separated

Intended Use

The AutoLys Tubes are specimen receptacles specifically intended for the primary containment, preservation, and automated lysis of liquid specimens, such as tissue, blood, saliva, urine, as well as biological evidence on carrier substrate, for the purpose of in vitro examination, e.g., forensic, genomic, clinical research, and food testing. The specimen receptacles are designed to facilitate automated cell lysis, releasing cellular components (e.g., nucleic acids) for subsequent analysis. They are intended to be used in combination with Hamilton liquid-handling robots, specifically the Microlab STAR. This ensures a fully automated workflow for specimen processing and analysis.

You can download the Instructions for Use (IFU) in multiple languages above. Additional languages are available upon request.

Transport and Storage

The Hamilton AutoLys Tubes and Caps are packaged in a sealed bag and packed in a cardboard box. They are
therefore protected against moisture and transport damage.

Transport: The product must be transported at temperatures between -15 °C (+5 °F) and +55 °C (+131 °F) up to a maximum of 90 days. This is indicated on the secondary label (cardboard box).
Storage: The product must be stored at temperatures between 0 °C (+32 °F) to +35 °C (+95 °F) until expiration. This is indicated on the primary label (bag)
Short-term temperature peaks: Up to +55 °C (+131 °F) for a maximum of 90 days and storage up to +45 °C (+113 °F) for up to one year at any point during the product shelf-life period are validated and do not affect product integrity.
Relative Humidity: Not required.

Important Note on Product Assembly

To ensure reliable application, it is essential that the inner tubes, outer tubes, and caps are used from the same production lot. Mixing parts from different lots is not recommended, as it may compromise the quality and functionality.

Purity Grade

The AutoLys Tubes are produced in a Cleanroom (ISO Class 8) and are free of Pyrogens, RNAse, DNAse, PCR Inhibitors, Human DNA, and ATP. With the packaging format described on the left, it is ensured that the AutoLys Tubes maintain their Purity Grade status during both transport and storage.

Sterility

The AutoLys Tubes are treated with ethylene oxide (EO). This is indicated on the primary and secondary label. On the secondary label is an indicator that turns green after treatment.

Shelf Life

The AutoLys Tubes have a shelf life of 5 years, after the date of production. The shelf life is indicated on the primary and secondary labels. After opening the sealed bag, the shelf life remains unchanged, but the product's purity can no longer be guaranteed. It is recommended to perform a visual inspection for damage to packaging prior to use and to open the sealed bag just before use

Legal Aspects

Hamilton Company and Hamilton Bonaduz AG are the Legal Manufacturers of the AutoLys Tubes,
all rights reserved.
This Instructions for Use (IFU) document may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Company or Hamilton Bonaduz AG.

Note
Any serious incident or near-incident that has occurred in relation to the consumables shall be reported to Hamilton and to the competent authority of the Member State in which the operator is established.
Contact Hamilton either by contacting a local Hamilton representative or by utilizing Hamilton’s webpage, which can be found on the footer of this document.
If you have questions on our other consumable products such as: reservoirs, plates, tubes, sealing consumables, and waste consumables please visit our website under this link:
https://www.hamiltoncompany.com/consumables-labware-accessories