SAN DIEGO, Calif. – February 10, 2004 – Pharmatek Laboratories, Inc. today announced the completion of its new state of the art cGMP stability storage and testing capabilities. The company has added additional storage capacity including standard storage conditions, meeting ICH guidelines, as well as a range of other environmental conditions required for specialty products.
This expanded service offering follows the Company’s move in August of 2003 to a new pharmaceutical chemistry development laboratory located in the heart of San Diego’s biopharma region. Pharmatek’s expanded stability storage includes multiple new chambers covering a broad range of storage conditions.
Pharmatek performs release and stability testing for all types of drug products, from small molecule drugs to biomolecules to drug-coated medical devices. Analytical services 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) to support clinical trials, IND, NDA and aNDA applications.
“Our scientists have years of experience performing all types of analytical testing on a wide range of drug substances and drug products. We have made a significant investment to increase capacity and put additional quality systems in place to provide this service on a much larger scale,” explained Tim Scott, President and COO of Pharmatek. There has long been a shortage of high quality cGMP storage services, particularly on the West coast,” added Scott, “pharmaceutical and biotech companies in Southern California, the Bay Area, Seattle, British Columbia and elsewhere in the West like to have high quality storage and testing of their samples in their same time zone.”
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 ±2ºC 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. Backup power is fully operational within 6 seconds of power failure.Leave a reply →