The result ensures that the company – a subsidiary of Dishman Pharmaceuticals - meets all the necessary design specifications for the containment of HPAPIs.
“This is an important milestone for Carbogen Amcis and the Dishman Group,” said Charlie Johnson, head of Switzerland-based Carbogen’s high-potency business unit.
“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.”
Tests at the site in Ahmedabad were carried out by UK-based industrial hygiene consultants, VEGA Environmental Consultants, in accordance with the International Society for Pharmaceutical Engineering’s (ISPE) standardised measurement of equipment particulate airborne concentration (SMEPAC) guidelines – a widely accepted industry standard.
Vega’s consultants checked performance parameters at the Dishman-owned Ahmedabad site using certain industry standard surrogate tests which evaluate whether HPAPI compounds are being safely handled.
A substance designed to mimic the behaviour of the HPAPI was used to test the efficacy of isolators for solid handling operations in the manufacturing suites. Operator exposures were then measured, and results found to be below 0.1µg/m³ - well within safe limits.
Workers at the site are involved in manufacturing compounds of the highest occupational exposure band, which include category 1 carcinogens.
Carbogen Amcis was bought by the Dishman Group in 2006, and handles all HPAPI services for the organisation – such as developing compounds for preclinical studies, clinical trials and commercial use - through its state-of-the-art facilities in India and Switzerland.
The 4,300 sq m site in Ahmedabad was constructed in 2010 at a cost of $20m (€14m), and is fully compliant with current good manufacturing practice (cGMP). It also includes an analytical laboratory and warehouse.