Do You Know the Difference Between Extractables and Leachables?

resin pellets

Understanding the subtle difference between extractable and leachables is important when selecting sample storage tubes, both can be present in inferior products due to poor manufacturing techniques but more importantly both can be avoided entirely.

The difference

Extractables

Extractable are chemical species / compounds that can be extracted from a primary container or component material (e.g. the elastomeric or plastic components) into drug or biological product & contaminate and/or cause various potential issues. Extractable are mostly generated by interaction between products and their packaging over time, usually under extreme conditions e.g. the presence of strong solvents or elevated temperatures. Extractables can be caused through gamma-irradiation (Shah et al, 2013).

Leachables

Leachables are compounds that leach into the drug or biological product from the container-closure system such as the elastomeric or plastic components, or coatings of the container and closure system. Leaching is mainly as a result of direct contact with the formulation under normal conditions of use. Leachables are typically a subset of extractables and have potential to affect the product in various ways (Shah et al, 2013). Leachables can be present due to additives or steps during the manufacturing process e.g. release agents, coatings etc.

 

These distinctions can create a little-known dilemma for researchers. Leachables and extractables can be present in sample storage consumables manufactured using either:

  • Inferior manufacturing techniques compared to FluidX Sample Storage Tubes
  • Lack of control of additives or agents used in the raw materials

Leachables could always be present in an inferior quality sample storage tube, whereas extractables may only be present after gamma irradiation to sterilize tubes produced in a non-sterile environment.

Do not risk your sample integrity, your sample may be in direct contact with the Polypropylene resin of the tube for more than 10 years and any leachables can have an impact on the quality of your sample – in independent testing FluidX tubes were the only sample tubes tested to consistently show no leachables or extractables.

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N. P. Shah, N. M. Patel, P. K. Patel, (2013) Impact of Steam and Gamma Processing on Extractable, International Journal for Scientific Research & Development.