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Technical Consulting - Pharmaceutical
and Biotech
Industry
SAI
performs Technical Consulting Services to ensure clean, sterile and/or
contained process operations. Our strength is in optimizing CIP/SIP
technology in traditional and non-traditional applications, including:
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Fermentation and MCC operations through Bio-Safety Level 3
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Cleanable isolation/barrier equipment for containment and/or sterility
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Freeze dryers, unloading and loading accumulation barriers
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Large
and small scale organics operations involving reactors, overhead ductwork
and condensers, centrifugation, filtration and drying operations
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API
operations, involving milling, blending, dry product conveyance, particle
classification, bagging and dust collection
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Blood
processing/plasma fractionation facilities
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Fully
contained process/CIP/SIP operations for high potency products
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Solvent based CIP applications
Most
frequently requested technical consulting services involve:
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P&ID's and specifications review to ensure effective process/CIP/SIP
integration
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Piping model reviews to ensure cleanable, steamable installation
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Vendor drawing reviews for equipment cleanability, spray device placement
and spray specification
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Process/CIP/SIP operations audits to optimize system performance while
minimizing utility and chemical usage and waste generation
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Spray
performance test (riboflavin) results evaluation; defining remediation to
obtain the desired results
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Create/review user and functional requirements, software design and factory
acceptance testing
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Develop sequential color coded process/CIP/SIP operations - the visual
functional requirements
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Process/CIP/SIP training, providing both classroom and hands-on experience
This
listing is not comprehensive; if the support you desire is not listed,
please contact us to determine if we can serve
you in a beneficial capacity. |
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