External Qualification to Evaluate Safe Handling of Highly Potent APIs28 April 2011
BUBENDORF, Switzerland (April 28, 2011) — CARBOGEN AMCIS AG has announced that its commercial facility for multi-purpose production of highly potent Active Pharmaceutical Ingredients (APIs) has fully met all design specifications for the containment of highly active APIs. The facility, located on the site of its parent company, Dishman Pharmaceuticals and Chemicals Ltd., in Ahmedabad, India, limits worker exposures to <1 µg/m3 (8hr-TWA)a and is thus capable of manufacturing compounds of the highest occupational exposure band (Category IV), which includes, for example, IARCb Category 1 carcinogens. Performance within the design specification was verified through application of industry standard surrogate testing designed to evaluate the safe handling of highly potent APIs.
“This is an important milestone for CARBOGEN AMCIS and the Dishman Group. We have successfully undergone an in-depth and scientifically rigorous qualification process of our containment equipment, led by an external consultancy with a strong reputation and expertise in industrial hygiene,” said Charlie Johnson, Head of High Potency Business Unit, CARBOGEN AMCIS AG.
The containment performance validation was completed on-site by VEGA Environmental Consultants Ltd., the independent UK-based industrial hygiene consulting company. Containment testing was performed according to ISPE’sc SMEPAC-guideline,d a widely accepted standard in the pharmaceutical industry. Isolators for solid handling operations in the high potency manufacturing suites were challenged using a surrogate substance and operator exposures were measured to be below 0.1 µg/m3 calculated as an 8hr-time weighted average.
This result ensures that CARBOGEN AMCIS meets current industrial standards for the safe handling of highly potent solids in the evaluated containment areas.
CARBOGEN AMCIS AG (www.carbogen-amcis.com) is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development allowing customers to make the best use of available resources. CARBOGEN AMCIS AG is owned by Dishman Pharmaceuticals and Chemicals Ltd., Ahmedabad, India.
Dishman Group (www.dishmangroup.com) is a global outsourcing partner for the pharmaceutical industry, offering a portfolio of development, scale-up and manufacturing services. Dishman Group improves its customers’ businesses by providing a range of development and manufacturing solutions at locations in Europe, China and India.
VEGA Environmental Consultants Ltd. (www.vegaec.co.uk) is a UK-based leading occupational hygiene and environmental consultancy company offering services for the diagnosis, interpretation and resolution of complex environmental problems for clean room performance, occupational hygiene assessment and environmental testing.
Source: CARBOGEN AMCIS AG, Bubendorf, Switzerland
(a) 8-hour Time Weighted Average
(b) International Agency for Research on Cancer
(c) International Society for Pharmaceutical Engineering
(d) Standardised Measurement of Equipment Particulate Airborne Concentration