05.17.17
SGS has expanded storage capacity at its laboratory in Mississauga, Canada, for the stability testing of new drug substances and products for full regulatory compliance. The investment has seen the total storage capacity increase by nearly 200 cubic meters, to an overall total of approximately 450 cubic meters.
The additional capacity is split between six new chambers, which cover four standard storage conditions: 2-8 degrees Celsius, minus 20 degrees Celsius, 30 degrees Celsius/65% relative humidity, and 40 degrees Celsius/75% relative humidity. The chambers operate using a fully validated dual redundant cooling system with switch-over capability to ensure zero excursion in the event of mechanical failure, and are supported by gas-powered backup generators in the event of a prolonged power outage.
“We have seen a strong growth in demand for these services, not only from the biopharmaceuticals market, but also within the small molecule space,” said Michael Lindsay, vice president, life sciences Canada, SGS. “The additional capacity this expansion brings will allow us to reconfigure our existing assets to provide the standard frozen, refrigerated, accelerated and intermediate stability conditions, as well as to provide capacity for custom conditions.”
Across its global network of facilities, SGS offers a wide range of studies to monitor drug stability, including long-term drug stability and accelerated stability studies, shelf life assessment, in-use studies, short-term temperature excursion studies, and forced degradation assessments according to ICH Q5C and ICH Q1B. At the company’s laboratory in Wavre, Belgium, a new stability chamber has been installed, adding 84 cubic meters of capacity, bringing the total capacity to over 330 cubic meters.
The additional capacity is split between six new chambers, which cover four standard storage conditions: 2-8 degrees Celsius, minus 20 degrees Celsius, 30 degrees Celsius/65% relative humidity, and 40 degrees Celsius/75% relative humidity. The chambers operate using a fully validated dual redundant cooling system with switch-over capability to ensure zero excursion in the event of mechanical failure, and are supported by gas-powered backup generators in the event of a prolonged power outage.
“We have seen a strong growth in demand for these services, not only from the biopharmaceuticals market, but also within the small molecule space,” said Michael Lindsay, vice president, life sciences Canada, SGS. “The additional capacity this expansion brings will allow us to reconfigure our existing assets to provide the standard frozen, refrigerated, accelerated and intermediate stability conditions, as well as to provide capacity for custom conditions.”
Across its global network of facilities, SGS offers a wide range of studies to monitor drug stability, including long-term drug stability and accelerated stability studies, shelf life assessment, in-use studies, short-term temperature excursion studies, and forced degradation assessments according to ICH Q5C and ICH Q1B. At the company’s laboratory in Wavre, Belgium, a new stability chamber has been installed, adding 84 cubic meters of capacity, bringing the total capacity to over 330 cubic meters.
