Extractable and Leachable Studies

Extractables and leachables (E&L) testing is used to analyze product packaging to ensure the packaging components will not leach harmful chemicals into the product during its meaningful lifespan. Avomeen’s expert chemists are trained to identify and quantify both extractables and leachables, validate the analytical methods utilized, and determine potential safety implications that may be present, as well as suggest alternatives if necessary.

Safety is Paramount in Biopharmaceuticals & Product Packaging

Even in carefully produced packaging, potentially harmful organic and inorganic compounds are released by containers and leached into the pharmaceutical and medical device products. Avomeen’s trained and experienced scientists help ensure the overall safety of the finished product.

Beyond Testing with a Modular Approach

In today’s world of pharmaceutical and product innovation, it is not enough to just run tests and generate reports. Effectively approach risk mitigation of extractables & leachables with the assistance of Avomeen’s consultative expert scientists who are well-versed in advanced analytical technology, interpretation of data, and regulatory guidance and standards.

Scientists with decades of industry and laboratory experience are on-hand to work directly with your team. Avomeen’s industry-leading experts will consult with your team regarding the safety implications of your test results and suggest alternative container systems where necessary.

Our risk-based methodology expertise results in a customized approach for your specific phase of biopharmaceutical development. It is an ideal way to selectively choose only the testing you need at your current stage of the drug development process.

Specialization Makes a Difference

Our skills are wide-reaching, but we take exceptional pride in our ability to handle extractables & leachables studies. Avomeen’s E&L chemists specialize in:

  • Extractables & leachables evaluations
  • Extractables screenings (intelligent planning for materials selection)
  • Ensuring the compatibility of drug & containers and closures
  • Method development & validation for leachables studies
  • Developing routine extractables control methods
  • Ensuring safety relative to packaging adulterants that may enter the supply chain

Avomeen will work with you to develop a customized testing protocol. Our scientists will address requirements for pharmaceutical packaging, medical device registration, and label migration studies to determine the presence of unknown contaminants.

We Will Handle the Science

Routine testing labs are unable to provide customized, risk-based protocols and complex method development and validations. Furthermore, they will not have the resources to make informed and pertinent recommendations according to data, regulations, and guidance. That is why so many people trust Avomeen for a complete solution. Industry-leading chemists and scientists work hands-on with individual projects and clients to tailor every test and consultation to ever-changing needs.

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