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Biobook Taylor Made
Bespoke configuration for specific needs: custom vessel geometries, sensors and automation. Engineered around your process, from concept to acceptance test.
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- Every system ships with a declaration of conformity and a technical file under the applicable European directives.
- Control panels are built and certified to the US standard for industrial control panels — UL file E554925.
- Pressure vessels are designed and certified to the European directive when the destination market requires it.
- For markets that require it, vessels follow the ASME VIII code; finishes, welds and connections follow ASME BPE.
- Materials, surface roughness and hygienic design are made for GMP environments. IQ/OQ qualification of the installed system is one of our services.
- Bioflex™ handles audit trail, electronic signatures and access control as required by the FDA rule on electronic records.