Elletra’s presentation : December 2003 A quick presentation of TANGO.
UniTao Presentation
-
Upload
bob-conlon -
Category
Documents
-
view
84 -
download
0
Transcript of UniTao Presentation
Brief Introduction UniTao’s production facilities contain world class, multi-
purpose synthesis equipment that has been used in the manufacture of API for human, veterinary, and clinical research products
Significant capacity available from small to large volume Wide breadth of product capabilities Site and employees have strong community and government
connections Excellent history with regulatory, environmental, and safety
agencies
Three production buildings - Synthesis 1, 3 and 5 Four laboratories – analytical, process chemistry, PFW & waste water Two warehouses – main & drum storage One administration building & one office building One bulk chemical storage area - tank farm Multiple maintenance & equipment storage buildings Property - 180 acres, with facilities occupying 85 acres
Buildings & Property
Summary S1 S3 S5 TotalConstruction Completed
1978 1996-2001 2009
Reactor Volume (cbm)
82 30 82 194
Reactors 14 12 13 39Centrifuges 6 3 4 13Dryers 6 4 4 14Production Bays 6 4 4 14
Open floor concept (S5) – reactors on same floor, not physically separated
Full recipe control capability (S5)Restricted bay access for controlled substance production (S3)Potent compound production facilities (S3)Technical area separated from product contact area (S3, S5)Wide range of reactor capacity (from 0.1 m3 to 7.6 m3) for flexible
volume
Buildings & Equipment
Warehouses & Tank FarmMain warehouse storage for 3,000 pallets at room temperature (20°C to 25°C) Refrigerated storage for 24 pallets at cold temperature (2°C to 8°C)Controlled substance vault storage for 300 palletsDrum storage warehouse for 456 pallets (60 water reactive, 166 temp controlled)Bulk chemical storage – 15 tanks (125,000 gal/851,715 l)
Quality Control Laboratory Ample lab space and well-designed layout enables compliant and
efficient operation Equipped with state of the art analytical instrumentation Constructed to meet DEA requirements for controlled substance
compounds handling
Controlled Substance Capabilities Extensive video surveillance system and ample storage capacity Site has had numerous successful DEA inspections under
previous ownership; UniTao plans to continue same level of compliance
Potent Compound Capabilities Small scale production in walk-in hood and isolators Long history of category 3 material production
Environmental Controls Site has a strong history of environmental compliance Wastewater treatment and thermal oxidizer capacity an excellent
match for production capability Recognition for environmental systems (2008 Virginia Governor’s
Environmental Excellence Award and 2010 National Industrial Water Quality Achievement Award)
Specialties
Competent staff with average >15 years pharma experience Employees and service providers hold extensive site knowledge Maintaining strong relationships with key external partners
Chemical distributors Engineering firms Local university Manufacturing organizations Suppliers State and local government
Qualified & Flexible Resources