This Disposable Technologies training webinar in GMP Facility will guide you through the practical aspects of implementing disposable technologies and offer superb control of process stream contaminants such as endotoxins and bioburdens.
The 21st century has seen the introduction of increasingly diverse and competitive single-use technologies for Bioprocessing. This case study will highlight the extensive implementation of disposable filters, vessels, connectors, mixers, sampling devices and bulk storage containers in a GMP facility. The use of disposable technologies enabled facility design and construction in only 12 months at a modest cost of only $13 million.
A hybrid approach to facility design was employed to leverage the benefits of conventional equipment by augmentation with new disposable technologies. Disposable technologies benefited the project through reduced capital outlay, shorter equipment lead times, faster construction and rapid startup, enabling aggressive cost and timeline targets to be met. Disposable technologies enhanced GMP operation by offering superb control of process stream contaminants such as endotoxins and bioburdens.
Implementing such leading-edge technologies brings new challenges, especially for change control, vendor selection and validation. This discussion will also focus on practical aspects of implementing disposable technologies, including:
- Accelerated Timeline Management.
- Supply Chain Management (preferred vendor selection, change control).
- Regulatory Advantages (closed processing, eliminate cross-contamination).
- Streamlining Operations (tank farm flexibility).
- Validation savings and challenges (mixing, extractable, leachables).
Areas Covered in the seminar:
- Highlight extensive implementation of disposables in a Bioprocessing facility.
- How a hybrid approach was employed for facility design.
- Challenges that occurred in the implmentation.
- Cost effectiveness.
- Process control benefits.
- Supply chain management and time management changes.
- How well planned implementation can produce streamlined operations.
- Validation benefits.
Who will benefit:
- End-users responsible for applications that need to be validated
- QA managers and personnel
- Engineering, commissioning, process design professionals
- Validation specialists
- Consultants
- Quality system auditors
Instructor Profile:
Peter K. Watler, Ph.D is Principal Consultant and Chief Technology Officer with Hyde Engineering + Consulting. He has 22 years of GMP biopharmaceutical process experience with a focus on process design, scale-up, implementation and facility design, start-up and qualification. He has prepared 3 license submissions and participated in several FDA inspections and GMP audits.
Dr. Watler was previously Vice President, Manufacturing at VaxGen, where he led the design, construction, commissioning and qualification of a GMP vaccine facility. He was also responsible for managing supply chain and production operations, led the CMC team and prepared submissions for government agencies. He previously spent 12 years at Amgen, leading process development, manufacturing support and overseeing pilot plant operations. He has led teams for technology transfer, scale-up, pre-clinical production and process validation for Neupogen®, Stemgen®, Kepivance® and Infergen®. Dr Walter holds a Bachelor’s and a Master’s degree in Chemical Engineering from the University of Toronto and a Ph.D. in Chemical Engineering from Yamaguchi University, Japan.
