Our expert teams can analyse exposure to APIs in pharmaceutical and dose form manufacturing environments. A significant analytical challenge is to validate robust highly sensitive methods that meet the occupational exposure limits, particularly for potent actives. Method development must determine a suitable extraction solvent, swab and IOM filter recovery, solution stability and specificity (from blank swab and filter peaks). This may require specialised hardware including uHPLC and MS/MS detection.
The skills required to carry out this work are similar to those we employ in cleaning validation exercises and are grounded by our extensive skills in method development for other sensitive HPLC applications such as related substance or cascade impaction analysis. This means we can develop tests for new APIs very quickly.
As a cGMP-certified laboratory (MHRA) we have significant experience in method validation. We have validated over 200 HPLC methods for pharmaceutical actives in accordance with ICH guidelines. All analysis is carried out on cGMP-qualified uHPLC systems.
We have also developed considerable experience and built an extensive scope of accreditation in the analysis of air samples to support Occupational Hygiene and Environmental investigations. Our focus on chemical analysis makes us a known choice for trace contamination identification and quantification. Many of these routine tests we perform are UKAS accredited with methods based upon MDHS, OSHA and NIOSH methodologies. Sampling media such as bottles, filters, impinger solutions, sorbent tubes, TD tubes and passive badges can be provided if required.