What are Extractables & Leachables - and what is their significance for your single-use process?

Extractables are compounds that can be extracted from a packaging component, a delivery system or a manufacturing surface via laboratory manipulation, such as exposure to solvents or heat. Extractables can be potential leachables.

Leachables are compounds that passively migrate into the medicinal product over time from the packaging system, components in use or a manufacturing surface as a result of direct contact.


Extractables and Leachables (E/L) studies are important in identifying and quantifying potentially harmful leachables that may migrate from the container, equipment and packaging, thereby contaminating the pharmaceutical products as this may pose a risk to the patient's health and result in significant problems in terms of quality.

That is why all our single-use components come with full documentation - including E/L and BPOG, which is the strictest standard in the field.

Data package

Our single-use products can be delivered with full documentation - including:

  • FDA
  • USP Class VI
  • EN10204-3.1
  • E&L data
  • Gamma irradiation & Sterility Assurance Level SAL 10-6
  • Produced in minimum ISO Class 7 Cleanroom
  • USP 85
  • USP 87
  • USP 88
  • USP 788
  • ADIF
  • TSE/BSE statements available
  • CoA
  • BPOG protocol


The products that we offer our customers all live up to the requirements that are set in relation to use, hygiene, environment and serviceability.


This means that all our products are type approved and produced in appropriate materials, such as platinum-cured silicone and TPE.


We know the importance of absolute cleanliness in pharmaceutical processes, and with single-use systems you not only achieve perfect cleanliness, but also savings in time and in the use of cleaning agents.



We sell various types of single-use equipment, including:

  • Tubes
  • Fittings
  • Assemblies
  • Bottles and containers
  • Tube sealers and welders
  • Pass-through systems
  • Clamps
  • Bags
  • Pumps
  • Valves
  • Moulded assemblies

Would you like to find out more?

Contact us if you require any help, advice or want to find out more about our single-use solutions.
Silvia Roma Bentin
Internal Technical Sales
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