Welkin has successfully delivered upstream and downstream process piping and tank projects in the fields of monoclonal antibodies, vaccines, recombinant proteins, dialysis solutions, blood products, peptides, and small nucleic acids to renowned biopharmaceutical clients both domestically and internationally.
Features of the Welkin Pipe and Tank System
· Sterility assurance;
· Complies with ASME BPE, ISPE, CGMP, EU, and FDA standards, meeting global pharmaceutical equipment requirements;
· Customized design is employed to minimize material residue, enhance yield, and reduce the consumption of raw and auxiliary materials;
· Provide a comprehensive 3D model of the entire area that meets cleanliness, operation, maintenance, inspection, and expansion requirements, as well as EHS standards, while incorporating utility and MEP interface information for integrated management.
· Modular system design, with 1:1 fabrication in the factory followed by comprehensive functional testing (supported by fully equipped utility systems), enhances the quality and speed of system delivery while reducing on-site installation, commissioning, and validation time.
· Customizable batch reports that present comprehensive records of CIP, SIP, integrity testing, and production processes (including trend curves). The system automatically logs parameters and steps for each batch’s production, cleaning, or sterilization process, generates batch reports on demand, and enables retrieval and printing based on specific requirements, thereby ensuring data traceability and reliability.
· Programming based on ISPE guidelines, with modular construction of the program’s underlying control logic and recipe-based management, compliant with the ISA88 standard and meeting batch-processing requirements;
· Develop and execute validation protocols for RA, RTM, VP, DQ, IQ, OQ, etc., and provide support for PQ;
Our process pipe and tank equipment includes:
Culture medium preparation and storage system, feed supplementation system, harvest and clarification system, buffer solution preparation and storage system, sample loading and temporary storage tank system for separation and purification, biological inactivation system, and others.
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