A major concern to the pharmaceutical industry is determining the level of exposure and subsequent risk that potent pharmaceutical compounds pose to those who manufacture and prepare them
With 20 years experience in HPLC techniques, ESA Services offers method development, validation and analysis of actives and surrogates through its sister company, ESA Analytical, based in the UK.
ESA routinely provides custom analytical methods for air and wipe samples.
With access to a variety of detectors including HPLC-electrochemical detection, evaporative light scattering detection, UV/vis, fluorescence and LC/MS, the most sensitive and selective method for the compound is developed.
The first step in developing a process for air sampling is to search its extensive database.
If a fully validated method has already been developed or a method for QC or cleaning validation exists, this may be used as a starting point.
If no method exists, the development process proceeds in phases.
In phase 1 an analytical technique yielding the highest sensitivity and specificity is developed. Reporting Limit (RL) and the dynamic range of the analytical method are also determined in this phase.
Phase 2 determines the optimum sample collection/analyte desorption technique.
In phase 3 the developed method undergoes a rigorous validation process. Progress reports are written after each phase and at the completion of the validation the client receives a signed copy of the fully validated method.
A new air monitoring method generally takes 20-30 hours to develop, after which ESA Services will analyse samples on a per sample basis with a five-sample minimum. In an industry faced with the challenge of containment of potent compounds, ESA Services's expertise provides a ready and affordable solution.
If products or precursors are of a proprietary nature, ESA Services is experienced in working under confidentiality agreements.
