Supporting QA/QC and R&D for the Pharmaceutical and BioPharmaceutical Industries

McCrone Associates offers a unique combination of independent expertise, expert particle isolation skills, advanced particle analysis capabilities, and regulatory-aware consulting that helps protect product quality and patient safety by getting to the root cause of a contamination or precipitation issue. Particularly when unexpected particulate materials are discovered in products from R&D and/or manufacturing processes.

At its core, McCrone Associates provides independent objective third-party particle identification. When unexpected particles, contaminants, or material defects appear, companies need unbiased conclusions they can trust and defend. As an independent ISO 17025 accredited laboratory, McCrone Associates ensures its microanalysis results are credible for internal decision-making as well as for regulatory, legal, and audit situations.

McCrone’s value is amplified by 70 years of specialization in microanalytical techniques—including polarized light microscopy (PLM), scanning electron microscopy with energy dispersive x-ray spectrometry (SEM-EDS), Fourier Transform Infrared (FTIR) spectroscopy, and Raman microspectroscopy. A range of additional techniques are also available. These methods allow scientists and microscopists to isolate and identify particles and distinguish between intrinsic, extrinsic, and process-related materials. Bulk-method analysis techniques used for routine quality control testing do not provide meaningful particle identification results because the particulate of interest typically occurs in very small quantities. McCrone’s particle approach relies on the exceptional skills of our isolation microscopists. Typically working in an ISO 14644 Class 5 cleanroom to prevent particulate cross contamination isolation microscopists manually manipulate particles as small as one micrometer and mount them on sample substrates appropriate to the analysis methods used. This allows for analyses with excellent signal to noise ratios and free from dilution effects. McCrone’s approach enables faster closure of root-cause investigations and more accurate risk assessments.

McCrone Associates understands pharmaceutical quality systems and regulatory expectations. Its scientists follow processes that align with ISO 17025 and cGMP requirements, and passes FDA scrutiny, making reports directly usable for deviations, CAPAs, and regulatory responses. Combined with an expert scientific consultative, collaborative approach, McCrone Associates helps pharmaceutical companies get to the root cause, resolve issues efficiently, reduce manufacturing disruptions, and strengthen long-term contamination control strategies.

Our staff of expert scientific detectives are ready for your next investigational analysis challenge.