K‑Prime 40 BioChromatography Systems
Description
The next generation K-Prime 40 chromatography systems enable the user to separate and purify a broad range of proteins, vaccines, Mab's and other bio-engineered products at the methods development, pilot separations and large manufacturing scales.
Each system is designed to provide a full range of features and capabilities which meet the most stringent and demanding purification requirements. Each system may be fitted with a wide variety of options to configure the system to meet your specific needs. The units are sanitary in design, with pipework configured to ensure optimal fluid management, near-zero un swepted volume with no cross-port contamination from deadlegs or trapped fluids. This results in superior chromatographic separations with improved purity and increased product yields.
Industry-standard instruments, sensors and "off the shelf" components are used ensuring high system reliability, quick availability of spare parts and minimized process down time. Each unit is supplied with a comprehensive Users Manual and Validation Guide and is subjected to a full Product Acceptance Test (PAT) prior to shipment thus ensuring proper operation at the customers site. All wetted materials are FDA conforming or are subjected to USP VI testing to ensure suitability for BioPharm applications
Data Handling and Security
Full monitoring and recording of process parameters is provided for compliance with cGMP procedures. All original data is recorded and stored in unalterable format which may later be viewed in several file formats.
To ensure regulatory compliance CCP meets 21 CFR Part 11 requirements for electronic signature and batch records.
Validation
Process validation tools are included to simplify documentation of system operation and the development of purification protocols during process development. Recipe development tools eases rapid scale up to the production suite. System operations are protected during execution with user-definable alarms to ensure process integrity and operational safety.
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