Validation and documentation engineers accompany each project through all steps of the V-model, starting with the URS and ending with FAT, SAT / IQ, OQ. BWT Pharma & Biotech can also support the customer in the PQ phase.
BWT Pharma & Biotech turnkey services and products include
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Concept Design, Basic Design, consultancy services, case studies
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Assistance for User Requirement Specification (URS)
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Detail Design
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PW, HPW, WFI and pure steam production
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Storage and distribution systems
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Complete sterile manufacturing systems including solution preparation, CIP/SIP and wastewater inactivation
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Ozone and heat sanitisation for distribution systems
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PLC systems and SCADA (supervisory control and data acquisition) according to 21 CFR Part 11, GAMP
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Design, maintenance & consultancy services
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Qualification, validation & full documentation packages according to cGMP