Pharmatek Laboratories cGMP Facility, United States of America
Pharmatek Laboratories operates a cGMP manufacturing facility in San Diego. The custom designed facility offers a range of manufacturing services. It is located within the Carroll Tech Centre, an advanced chemistry and biology laboratory built by Veralliance Properties. Pharmatek has leased the building from the developer.
An expansion to the cGMP facility was completed in October 2010. It has added roller compaction capabilities to the facility and has boosted the company's granulation capacity for a wide range of solid oral formulations. The expansion allows Pharmatek to better serve the Phase I to Phase II drug development needs of its clients.
The cGMP facility was launched as part of Pharmatek's relocation. The company was established in San Diego in 2003 with a 10,888ft² facility. It relocated to the new larger facility within Carroll Tech Centre in 2007.
Pharmatek also has an 18,000ft² high potent and cytotoxic facility within the two storey 66,244ft² Carroll Tech Centre building. The cytotoxic unit includes a development lab and two class 100,000 high containment manufacturing suites.
It was launched in February 2009 as part of an $8.5m expansion. An additional 12,000ft² of space is available within the complex to accommodate future expansions.
The state-of-the-art facility occupies 34,000ft² and includes four suites. Each suite is a stand-alone operation designed to offer high product containment and has dedicated HVAC and HEPA filtration systems. A unidirectional flow of product, equipment and personnel is maintained to prevent cross contamination. Product isolation within the suites is ensured through a state-of-the art pressure cascade.
The facility is equipped with blending, granulation, mixing, roller compaction, sizing, encapsulation, banding, tableting, coating and packaging capabilities.
Blending equipment includes one Turbula Blender, three V-blenders (1ft³ and 3ft³ and a blend master) and a lab-scale V-blender. There are three high shear granulators, one high shear mixer and one fluid bed granulator. Sizing equipment includes Comil conical mill size reduction equipment and a sieve shaker.
Encapsulation equipment includes three automatic encapsulators, one manual encapsulator and two microdose encapsulators. The banding machine is manufactured by Dott. Bonapace & C.
Packaging equipment includes an induction sealer, a blister machine, a capsule / tablet check weigher and a capsule / tablet counter. Two tablet presses, a perforated coating pan and a metal detector have been installed for tableting and coating. Additional equipment includes a lyophilizer, a microfluidizer and a micro balance.
The expansion of cGMP unit saw the installation of two roller compactors including a pilot-scale Vector make TFC-220 roller compactor and a Micro lab-scale roller with an hourly capacity of 20kg and 1kg respectively. The additions were made in response to client requests to equip the facility with roller compaction and dry granulation capabilities in order to handle certain projects.
The roller compactors expand Pharmatek's granulation capability for moisture sensitive and density-challenged APIs. API and other excipients will be compressed in between two rolling discs to increase the density of the material.
Together with the microdose capsule filling technology of Pharmatek, the roller compactors will provide an option for bigger fill weights in powder-in-capsule dosage forms.
The expansion tripled blending size capabilities with the installation of a 3ft³ V-blender that can operate at a capacity of up to 36kg. Additional equipment installed as part of the expansion includes a Bosch automated encapsulator with a capacity of 23,000 capsules per hour and a 32,400 tablets/hour instrumented tablet press made by Korsch.
The facility produces tablets, capsules, liquid-filled capsules, oral liquids, suspensions, emulsions and dispersions in oral dosage forms. It also performs clinical trial material manufacturing, batch record preparation and release, compounding, individual and bulk packaging / labelling, release testing, analytical methods development, cleaning method development, clinical trial material storage and distribution and stability testing.
It is equipped to carry out 150 discrete phase one and two production runs annually as per current good manufacturing practices.