With almost two years of planning and construction complete, Regis Technologies’ Potent Compound Suite 1 (PCS1) is in testing. On March 4th and 5th, an expert independent lab, Safebridge Consultants, Inc., performed a surrogate powder study on PCS1, in order to evaluate the containment capability of the suite and to verify the effectiveness of the engineering and administrative controls during a typical processing of potent compounds. This monitoring included collection of both air and surface samples. Air samples will be compared with Regis’ identified containment performance target concentration of 0.05 micrograms per cubic meter of air (µg/m3). Surface samples will be an indication of cleaning effectiveness.
Naproxen sodium, an active pharmaceutical ingredient (API), was selected and used as the surrogate material in this study for the following reasons:
Three Regis chemists enrolled in the study in order to estimate the likely range of exposure variability among persons of differing skill level, experience, and physical stature. After taking initial background air samples, Safebridge strategically placed sensors around the PCS1 and at the collar of each of the operators (i.e. in operator breathing zones) during respective rounds of operations. The chemists then went through powder handling, equipment cleaning, and accidental spill scenarios with the surrogate powder.
The team performed the testing using methodology specified by International Society for Pharmaceutical Engineering (ISPE) in Good Practice Guide “Assessing the Particulate Containment Performance of Pharmaceutical Equipment.” Safebridge will analyze the collected samples at their Industrial Hygiene Analytical Laboratory in Mountain View, California. Analytical results will be available within 3 weeks of the collection, and Regis will be able to review a draft report within 5 days of receipt of laboratory results.
When testing is complete, the PCS1 will be available for projects regarding the development of potent drug substances. Regis expects the suite to be active this spring.
Regis is excited to add potent compound capabilities to its almost 60 year long resume. Founded in 1956, Regis has long been recognized as a premier partner for the clinical and commercial production of small molecule APIs. Its outstanding compliance history, technical and project management teams, and central US location have made it the supplier of choice for emerging and mid-size pharma.
More information on Regis’ capabilities, team, and outstanding compliance history is available throughout the website.