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cGMP Mfr. Tour
Extraction & Purification Tour
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> Complex Technologies
> Large Molecule Biologics
> Small Molecule APIs
360° Extraction / Purification
Room Name Placeholder
View Rooms:
Extraction Room (Animal-free API Manufacturing)
Clarification Room (Animal-free API Manufacturing)
Buffer Preparation Room (Animal-free API Manufacturing)
Clean Room: Iso 8 - Room #DSP1 (Animal-free API Manufacturing)
Clean Room: Iso 7 - Room #DSP2 (Animal-free API Manufacturing)
200 L Lyophilization Room - Iso 7 (Animal-free API Manufacturing)
Process Development Lab (Supporting Services)
Quality Control Lab (Supporting Services)
Clean Room: Iso 8 - Room #DSP1 (Animal Origin API Manufacturing)
Clean Room: Iso 7 - Room #DSP2 (Animal Origin API Manufacturing)
Room Features:
Room Features and Descriptions
', '- Controlled, not classified (CNC)<br /> - Tanks: 3 x 2,500 L Extraction Tanks and 1 x 7,000 L Buffer Tank', '/etc/medialib/safc/virtual_tours/1-extraction-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<ul><li>Controlled, not classified (CNC)<br /> - Tanks: 1 x 3,200 L and 2 x 2,000 L<br /> - Distributive Control Systems (DCS)</li></ul>', '/etc/medialib/safc/virtual_tours/2-clarification-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<ul><li>NA<br /> - NA"</li></ul>', '/etc/medialib/safc/virtual_tours/3-buffer-prep-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<ul><li>1054 sq. ft.<br /> - Unidirectional flows, separate personnel / equipment entry airlocks, smooth cleanable walls and ceilings, minimize process drains and floor drains.</li></ul>', '/etc/medialib/safc/virtual_tours/4-clean-room-class-10000-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- (Class 10,000) processing suite<br /> - 660 sq. ft.<br /> - Unidirectional flows, separate personnel / equipment entry airlocks, smooth cleanable walls and ceilings, minimize process drains and floor drains.', '/etc/medialib/safc/virtual_tours/5-clean-room-class-100000-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<ul><li>Class 10,000 w/ a Class 100 area<br /> - 255 sq. ft.</li></ul>', '/etc/medialib/safc/virtual_tours/6-lyophilisation-room-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<ul><li>Purification of therapeutic proteins from either natural or transgenic sources.<br /> - Synthesis or modification of biopolymers (polyamino acids, carbohydrates, and polynucleotides).<br /> - Conjugation chemistry of large molecules to a variety of compounds.<br /> - Development services starting from literature procedures.<br /> - Adapting research quality products to GMP manufacturing.<br /> - Transferring existing process for API manufacturing.<br /> - Support from preclinical through commercialization including development of appropriate specifications.<br /> - Identification of process controls and risk assessment, and cleaning methods.</li></ul>', '/etc/medialib/safc/virtual_tours/7-n3-process-development-lab.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- Support services to the manufacture and release of Active Pharmaceutical Ingredients (APIs) according to the ICH Q7A guidelines.<br /> - Services provided include raw material qualification, method development and validation, stability studies and microbiological assays, sterility testing, microbial identification, environmental monitoring and cleaning validation.<br /> - Additional Cell Culture laboratory capable of testing various media using a variety of cell lines (e.g., stem cells) and the growth of cell lines used to produce therapeutic biopharmaceuticals..', '/etc/medialib/safc/virtual_tours/8-n3-qc-lab-lr-jpg.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- (Class 100,000) Processing Suite<br /> - 940 sq. ft.', '/etc/medialib/safc/virtual_tours/9-clean-room-class-10000-ani.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- (Class 10,000) Processing Suite<br /> - 600 sq. ft.', '/etc/medialib/safc/virtual_tours/10-clean-room-class-100000-ani.Par.0001.Image.jpg', '', '', '')){kind=link}