Leachable Studies

Validate suitability of disposable (single-use) components through studies designed to monitor compounds that may leach into the drug product or intermediate as a direct result of contact with the formulation under normal conditions.

A focus on collaboration between disposable (single-use) component vendors, laboratories, toxicologists, and the regulatory agency combined with open, effective, and timely communication ensures a successful study. Our extensive experience with mass spectrometry allows us to identify unknown compounds and specific contaminants that may be present when various disposable materials are used.

Service Overview:

Leachable compounds are a subset of extractables that leach into the drug product from the disposable component as a direct result of contact with the formulation under normal conditions. By applying their expertise in leachable testing to disposables, analysts at Lancaster Laboratories help clients verify that there are no adverse effects from the use of these components in their production process.

To test a disposable for leachable compounds, a protocol is developed that considers both the construction materials of the disposable and the manufacturing process where it will be employed. If needed, a toxicologist assists with risk assessment and establishes safe exposure levels as the use of disposables is still an emerging technology in pharmaceutical manufacturing and bioprocessing. Leaching of potential contaminants under normal (or sometimes accelerated) conditions is simulated to develop test solutions. The test solutions are then analyzed for a wide range of contaminants using techniques that provide qualitative data for use in identifying the source of any positive results.

Typical analytical techniques used to screen the resulting leachates include:

Liquid chromatography/mass spectrometry (LC/MS) to detect non-volatile compounds
Gas chromatography/mass spectrometry (GC/MS) to detect volatile and semi-volatile compounds
Inductively coupled plasma (ICP) or ICP/MS to detect metals

Spectra Libraries

Lancaster Labs has extensive experience using mass spectrometry as a tool to identify unknown compounds. In addition to information from commercially available libraries of spectra, analysts at Lancaster Labs has built our own library of spectra specifically containing compounds extracted or leached during studies of various disposable components. By purchasing standards, generating the mass spectra and maintaining a historical file of the information, analysts are gaining expertise with the specific contaminants that may be present when various disposable materials are used.

Leachable Studies

Service Details

Resource Library (1)

Service Overview:

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