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SGS Expands Stability Testing Capacity
PTSM: Pharmaceutical Technology Sourcing and Management
Expanded storage capacity at the SGS laboratory in Mississauga, Canada increases stability testing capabilities.
SGS announced on May 16, 2017 that it has expanded storage capacity at its laboratory in Mississauga, Canada, for the stability testing of new drug substances and products for regulatory compliance adding nearly 200 cubic meters, for overall storage of approximately 450 cubic meters.
The additional capacity is split between six new chambers, which cover four standard storage conditions: 2–8° C, minus 20 ° C, 30° C /65% RH, and 40° C /75% RH. The chambers use a 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.
SGS offers 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.