Pharmatek Laboratories offers state of the art cGMP stability storage and testing capabilities. Standard storage conditions meet ICH guidelines and additional storage options at a range of other environmental conditions are available for specialty products or needs. Each cGMP environmental chamber operates independently, with separate temperature and, where applicable, humidity controls. All chambers are continuously monitored by a computerized Tatus Monitoring System. Temperature and humidity setpoint windows are ±2°C and ±5% RH, respectively, with deviations outside setpoint ranges resulting in an immediate alert to Pharmatek staff. Additionally, all storage chambers are supported by full generator back up in case of power failure with a second backup generator if needed.
Pharmatek performs release and stability testing for all types of drug products including small molecule drugs, generics, peptides, biomolecules and drug-coated medical devices. Appropriate sampling strategies are determined, documented and executed with the utmost care. Analytical services supporting stability programs include: long-term stability testing, accelerated stability testing, comparative stability testing, forced degradation studies and stability testing of Active Pharmaceutical Ingredient (API) and Clinical Trial Material (CTM). These services support clinical trials, IND, NDA and aNDA applications.
Stability programs require an ongoing commitment to careful client-focused communications, accurately managed pull schedules and continual review of regulatory requirements. Pharmatek scientists have years of experience performing all types of analytical testing on a wide range of drug substances and drug products. Our extreme attention to detail and the highest level of quality assure our clients that their stability program will be successfully implemented.