Why is the use of mould release agents in the production of cryovials a problem?

  • UV stabilisers (e.g. benzophenone, benzotriazole, oxalanilide)
  • Antioxidants (e.g. organo phosphites)
  • Thermo stabilisers
  • Nucleation starters
  • Plasticisers (e.g. phthalate esters)
  • Mould release agents (also known as slip agents)
  • Antistatic agents
  • Irradiation protectors
  • Clarifiers.

Although useful in the manufacturing process, several studies have shown that polymer additives can leach from tubes and affect the outcome of biochemical assays. [i] [ii] [iii]

With cryo small-volume tubes being designed to store samples for open-ended periods of time, the risk of contamination caused by chemical elements and agents in the tube is something that researches and procurement professionals should be aware of when choosing such laboratory consumables.

Analysis has demonstrated that the absence of leachables is not a guaranteed feature of tubes intended for sample storage in biobanking. Raw material types vary between individual tube manufacturers and commonly accepted standards for materials with low additive content are still missing.

When purchasing cryovials, there are already many things to be considered such as the optimum size of tube to maximise storage capacity, traceability and all-round quality. However, purchasers should look beyond these and add other key indicators that a product is suitable for the intended application. These include:

  • USP class VI certified polypropylene tube material.
  • Free from:
    • DNA, RNase and RNase
    • Endotoxins
    • Heavy metals
    • TSE and BSE
    • Phthalate esters
    • Mould release agents
    • Antistatic agents
  • Sterility (for the storage of viable cells for future cell culture or cell lysis with subsequent biomarker analysis).

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i J Biomol Screen. 2014 Dec;19(10):1409-14.
ii Can J Physiol Pharmacol. 2012 Jun;90(6):697-703.
iii Clin Chem. 2009 Oct;55(10):1883-4.
IV Greiner Bio-One, Forum 21