CryoGen® Tubes 1D CLEARLine®

Are CLEARLine® CryoGen® Tubes CE marked?: Yes, they are classified according to the directive of In Vitro Diagnostic Medical Devices 98/79/EC – other devices.
Are CLEARLine® CryoGen® Tubes be used in accordance with IATA regulations?: Yes, they are. They can be used as primary container for the transport of biological substances (Category B) for air transport in compliance to packaging instruction PI650 of IATA.
Are the CLEARLine® CryoGen® Tubes of all sizes and shapes free from any animal origin materials?: Yes, they are. In plastic industry many of the polymers include small amounts of stearates derived from fatty acids, but for the manufacturing of CLEARLine® CryoGen® Tubes we do not use or intentionally add any ingredients of animal origin.
Are CLEARLine® CryoGen® Tubes suitable for IVF?: No, they are not classified for IVF (in vitro fertilization) or for working with human cells and human tissue which after frozen cycle applicable back to human.
Do operators prefer to use internal or external thread cap version?: Both closures are used in storage protocols without significant dominance of one in particular.
Do the raw materials used to produce the CLEARLine® CryoGen® Tubes conform to USP Class IV, safe for use for biologics?: Yes, they do.
Does the gasket (a thermoplastic elastomer) complies to the USP guidelines for elastomeric closures for injectable?: Yes, it does.
Does Biosigma performs any Leak test on CLEARLine® CryoGen® Tubes?: Yes, it does. After CLEARLine® CryoGen® tubes have been closed, they are positioned inside a specific container and subjected to a specific pressure to verify the perfect air-tight. The Leak test certificate is available upon request for each lot of production.
For how long the CLEARLine® CryoGen® Tubes are certified as sterile?: CLEARLine® CryoGen® Tubes are guaranteed sterile for 4 years from production date if the packaging is not damaged.
Is it also possible to store CLEARLine® CryoGen® Tubes in the liquid phase of the liquid nitrogen or it must be done only in the gas phase?: Storage in the gas phase is strongly recommended for security reasons. The immersion of CLEARLine® CryoGen® Tubes in the liquid phase may cause entrapment of liquefied nitrogen inside the vial and lead to pressure build-up, resulting in possible explosion or biohazard release.
Is it available any testing on extractable or leeching performed on CLEARLine® CryoGen® Tubes?: Yes, it is. The extractable study performed on CLEARLine® CryoGen® Tubes demonstrates that the analysed vials does not release significant amount of inorganic elements and/or organic substances in ethanol.
Is there a rule to consider for the CLEARLine® CryoGen® Tubes filling?: The important thing is that the CLEARLine® CryoGen® Tubes are not being completely filled, as the liquid may burst the tubes due to the volume expansion caused by the freezing process. Usually laboratories follow the rule that the tube should always be filled up to two thirds. The ideal filling volume corresponds to the upper marking on the scaling of the CLEARLine® CryoGen® Tubes .
Is there any documents where are indicated details and specifications on the method and process used to sterilize the CLEARLine® CryoGen® Tubes?: It is available a certificate of sterilization where it is stated that our CLEARLine® CryoGen® Tubes are sterilized by beta rays. The sterility assurance level (SAL) defined and to be used in routine sterilization in accordance to EN 556-1 is 10-6. Certificates of validated Beta rays treatment are available for download on www.biosigma.com.
What is the test-tube and cap material?: Test-tube is made in medical grade polypropylene and the cap is made in medical grade polyethylene/rubber. The combination of cap in PE and test tube in PP assures a better sealing and makes easier screwing. It avoids the grip effect caused by the use of the same raw material for both components.
What should be considered when storing samples in liquid nitrogen?: The storage of cells at temperatures below -130°C is essential in order to preserve the material unaltered. Many workers achieve that by the use of liquid nitrogen (at –196°C). The immersion of samples in the liquid phase may cause entrapment of liquefied nitrogen inside the vial and lead to pressure build-up, resulting in possible explosion or biohazard release. In order to prevent this, CLEARLine® CryoGen® Tubes should either be stored in the gas phase or they should be frozen and thawed inside an additional protective covering. So when dealing with liquid nitrogen, the following safety precautions should absolutely be taken: wear protective clothing, including protective glasses and cryogenic gloves. If the tubes should be removed from the liquid nitrogen without any protective covering, users should store them for 24 hours in the gas phase and then be removed safely.
Which is that maximum speed centrifugation for CLEARLine® CryoGen® Tubes?: The maximum speed centrifugation for CLEARLine® CryoGen® Tubes is 14.000 rpm.