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API OCCUPATIONAL HYGIENE MONITORING

Exposure to APIs released into the working environment can represent a significant hazard for employees in pharmaceutical API and dose form manufacturing environments. The nature of actives are exposure can negatively impact health, so understanding and controlling exposure levels is critical to a meeting obligations under Health and Safety regulations (e.g. BS EN 482:2006 and the proposed EN 689 revision: European Standard on Testing Compliance with Exposure Limits).

ASSESSMENT METHOD DEVELOPMENT AND VALIDATION

A significant analytical challenge is to validate robust highly sensitive methods that meet the OEL limits, particularly for potent actives. Method development must determine a suitable extraction solvent, swab and IOM filter recovery, solution stability, specificity (from blank swab and filter peaks). This may require specialised hardware including uHPLC and MS/MS detection.

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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. So we are able to 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.

EFFECTIVE SAMPLE COLLECTION AND ANALYSIS

With the analytical method validated it is vital that executing sample collection, packaging and dispatch in situ in the working environment are developed and workable, with appropriate documented procedures. We can develop, test and validate such processes, including if appropriate training local staff to carry out the sample collection procedures, handling and shipping arrangements etc.

Sampling media such as bottles, filters, impinger solutions, sorbent tubes, TD tubes and passive badges can be provided by ourselves.

ONGOING MONITORING

Once a full process is established, there is a need to ensure that cost-effective analysis can be carried out. Our High Throughput laboratory in Manchester has many years’ experience delivering highly sensitive sample analysis at cost levels which reflect those needs.