A comprehensive approach to validation is core to Hyde Engineering + Consulting complete service offerings. In addition to providing traditional validation services, we also provide a fully integrated engineering and commissioning service.
From the beginning of a design process, specification and design documentation is targeted towards end requirements; this ensures a fully operational process with cost and time savings, overall maximum efficiency, and resulting in a fully testable system.
Validation Services include:
- Validation Master Plans
- Cleaning Validation
- Commissioning
- Analytical Method Validation
- Equipment Validation
- Software Validation
Download PDF of Validation Services.
Aventis Pasteur
Hyde provided gap analysis services to AvP-USA, evaluating their cleaning equipment. Based on that analysis, we have provided equipment specification, control system programming and documentation, equipment validation, and cleaning validation services.
Baxter Hemoglobin Therapeutics, Inc.
Hyde provided validation services to Baxter for a renovated pilot-scale manufacturing facility in Boulder, Colo. Our work involved writing the Cleaning Validation Master Plan and developing and executing IQ and OQ protocols for process and CIP equipment. We also provided commissioning, OQ, and PQ of the CIP circuits for the process systems in the facility, and prepared and executed IQ and OQ protocols for the controlled process and CIP systems.
Centocor
The project at Centocor (a subsidiary of Johnson & Johnson) required cycle optimization and PQ for roughly 250 cleaning circuits in a dedicated manufacturing facility. We provided a detailed PQ Execution Plan that specified every aspect of the cleaning validation program, including system descriptions, sampling and analytical methods, acceptance criteria, and conditions for testing and re-testing. The Execution Plan formed the basis for development of a Master Plan, as well as cycle optimization procedures and PQ protocols for each circuit. The Execution Plan also allowed the various functional areas of the company to reach agreement on the overall cleaning validation approach.
Diosynth Biotechnology
Diosynth required the same deliverables as those we had provided to Centocor, with the addition of PLC and DCS OQ for eight CIP skids and circuit OQ for roughly 150 circuits in a multi-product facility. Our involvement at every stage of the cleaning validation allowed for maximum continuity and schedule alignment throughout the program. Here we demonstrated our ability to manage the hierarchical order in generating documented evidence of validated cleaning from start up to optimization, OQ to PQ.
The testing required at both Centocor and Diosynth was performed on a "worst-case" basis, whereby we could draw conclusions about system performance based on comparison to the worst-case scenario. For example, cycle optimization was performed using reduced (i.e., worst-case) cycle parameters, such as temperature and flow rate, so that PQ could be performed with the minimum conditions necessary to ensure passing results. This reduced-parameter approach guaranteed efficient use of plant utilities without compromising the efficacy of the cleaning regimen.
Pfizer Global Manufacturing
Hyde provided consultation to Pfizer in the development of a cleaning validation study for their new multi-product manufacturing facility in Lincoln, Neb. This work involved development of a Cleaning Validation Master Plan, consultation to Pfizer staff in the development and validation of sampling and analytical methods, spray device efficacy testing for process vessels and fermenters, establishment of acceptance criteria for residue levels, and CIP system programming and start up. We developed cleaning performance qualification protocols for the cleaning validation study and modified CIP units and piping to enable the recirculation of cleaning solutions.
Wyeth BioPharma
Hyde is currently providing validation services for a new multi-product large-scale biopharmaceutical manufacturing facility and a new multi-product pilot-scale biopharmaceutical manufacturing facility in Andover, Mass. This work includes IQ, OQ, and PQ protocol development and execution services for the process control systems and process equipment in the facilities. The control system OQ work has involved functional and OQ testing of PLC and SCADA system software, and the development and execution of CIP system OQs. We are also consulting with Wyeth BioPharma staff in the selection of sampling techniques, analytical methods, and spray device efficacy testing for process vessels. This work involves the development of Cleaning Validation Master Plans and cleaning performance qualification protocols used for the cleaning validation study, and will include commissioning of the CIP circuits and execution of the cleaning PQs and final reports.