FACILITIES
Yapan Bio is located at Genome Valley, Hyderabad, India, a state-of-the-art systematically developed R&D and clean manufacturing cluster.
Facility Overview
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Designed as per the:
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Global GMP expectations/guidelines
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Multi-product processing
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Appropriate Biosafety and cleanliness classification
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Appropriate safety and waste handling
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With segregation between:
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Organisms, products and/or technologies
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Processing steps (e.g. upstream & downstream operations)
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Components or equipment at different stages of cleanliness
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Utilizing adoption of:
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Modular construction
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Use of disposables (Single use)
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Unidirectional-flow to the extent possible
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Facility includes two suites:
Suite 1
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Designed for up-to BSL-2 level products
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Positively pressurized clean rooms
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Class C for Process area
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Class A/B for Final Filtration and Filling
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Area segregation into
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Material staging, Media/Buffer preparation, Seed, Upstream, Downstream, Cell Bank Room, Freezer Room, and Fill-Finish
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Two downstream rooms for step separation
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Attached fill finish area with semi-automatic liquid filling in vials
Suite 2
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Designed for high containment requirement products (infectious agents: BSL-2+)
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Negatively pressurized clean room with once through system
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Class C for Process area
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BIBO HEPA filter bank in the Class C area for exhaust air
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Decontamination Autoclave and fumigation Pass Box & Material Airlock
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Personnel Exit equipped with body shower
