Qualification of Packaging Materials (Cryotubes / Cryovials) for Biobanks according to DIN 13279:2022-05. Testing of Suitability for Storage, Dry Ice Transport, as well as Air and Road Transport.

We test and evaluate the container closure integrity of tubes used for your valuable samples. This helps prevent loss of viability, pH shifts by CO₂ ingress, and explosion hazards during thawing. Our detailed failure mode analyses provide confidence for manufacturers and end users, reduce storage-related risks, and safeguard sample integrity and long-term usability.

We offer comprehensive testing procedures to evaluate the product quality and safety of cryogenic primary packaging (cryotubes and cryovials):

• Transport Safety: IATA/ADR-compliant gravimetric leak tests under vacuum conditions (-40 °C to +55 °C) to simulate extreme cargo hold environments.
• CO₂ Leak Testing: Quantitative analysis of carbon dioxide accumulation during dry ice shipments to prevent sample damage caused by pH reduction.
• Storage Safety & LN₂ Resistance: Testing of material resistance against the ingress of gaseous or liquid nitrogen and minimization of burst hazards during thawing.- Aging Studies: Simulation of long-term storage scenarios (decades), including testing for leak tightness, burst pressure, and mechanical strength to determine material aging- Leaching Studies: Detection of potential contamination from leachable plastic components or production additives (lubricants/cleaning agents).
• Chemical Resistance Testing: Verification of label readability (barcode, 2D or 3D codes) after exposure to acids, alkalis, solvents, and other substances."