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Quality

Quality is paramount to Customized Bioprocess Solutions (CBS). Our customers have experienced an escalation in validation and other regulatory requirements through the decades and we have been there with them. CBS has always monitored current developments and been responsive to current GxP, EU, FDA and other requirements.

Our approach to quality assurance is based on meeting or exceeding customer expectations. In a fully customizable way, we build quality into our products, enabling consistent, intended performance and fitness for use. To support a proactive validation process, we base our functional and detailed design, construction and testing on user requirements. Combined with IQ and OQ products from GE Healthcare Life Sciences Fast Trak Regulatory & Education, time and money spent on validation can be reduced significantly when commissioning a customized BioProcess solution.

The quality system within CBS is certified to ISO 9001:2000. We have also developed our project methodology according to current GAMP guidelines, and apply recognized industry standards and regulations for hardware and software design and construction.

We offer systems with plastic and elastomeric wetted parts tested according to USP class VI, steel welds according to ASME-BPE requirements and support for 21 CFR part 11 compliance using UNICORN and PLC solutions, for instance.

We understand that our users define quality and strive relentlessly for excellent construction, production, delivery and customer relations.

Imagined - Custom designed bioprocessing solutions to your production requirements.

Delivered - Specification, design & manufacturing to installed, validated & tested systems.

Supported - Support services offered to clients with customized BioProcess solutions.