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Assess your sustainability practices, identify areas for improvement, and seamlessly integrate them into production.
Optimize waste management by implementing innovative recycling techniques. Use energy recovery and carbon capture initiatives to improve energy and material use.
Achieve energy, water, and space savings to build an effective operation with a greener footprint.
Visualize your process to support BOM creation, chemical compatibility assessment, aseptic boundary design and more
Build a comprehensive SUT library that dictates the whole project.
Reduce complexity with standardized single-use diagrams.
Plan for scalability from R&D to full-scale production.
Select the right materials for your process with an effective URS.
Create a naming convention optimized for speed and accuracy.
Design your process to be efficient and scalable from the start.
Standardize components to streamline design and qualification. Highly consistent and efficient.
Develop and deliver training programs on compliance and best practices.
Conduct internal audits to ensure continuous compliance.
Free up your operators time and improve your designs.
Stay ahead of regulations with thorough GMP risk assessment and mitigation.
Develop a risk-based URS spefic to your project needs.
Embed best practices into your project with expertly developed and managed SOPs.
Develop and manage BOMs from a single source of truth.
Ensure your Master data is uploaded in full.
Implement efficient inventory management practices to reduce waste.
Coordinate logistics to ensure timely delivery and reduce delays.
Qualify vendors and communicate effectively from the start.
Optimize supply chain processes to cut costs and streamline logistics.
Bring your E&L qualification program up to date with current regulatory expectations.
Mitigate supply chain risks with SU dual sourcing.
Assess your supply chains for sustainability goals including PFAs
Ensure your materials are fit-for-function for your process needs
Assess supply chain practices and ensure your materials will be available when you need them.
Benchmark SU waste management and develop a roadmap to improve recycling.
Ensure all your materials are integral and leak free prior to use.
Release your GMP materials on time.
Make data driven decisions to optimise your supply chain
Continuously improve your SU program to optimise for ESG goals
Ensure all stakeholders are mapped and engaged to ensure changes stick
Ensure your projects are on track and in budget
Ensure your material flows are operationally efficient
SCNs are impact assessed quickly and managed appropriately.
Ensure your qualified status is maintained through inevitable changes
Ensure the information in your SU library is working for you, not the other way around.
Ensure your product is free of unwanted contaminants from your SU materials
Ensure leak-free connectivity in your process with our welding and sealing expertise
Accelerate tech transfers by developing a process agnositc qualification approach for your SU materials
Work with the experts on deviations and root cause analysis
Create an industry-leading Validation Master Plan
Complete support from Raw material selection, sampling, testing, release and management
Develop and rollout of a best-in-class CCS
Large biopharmaceutical multinational
Monoclonal antibody
Qualification
Problem
Needed to de-risk commercialization schedule by bringing completing E&L qualification in unprecedented short timelines with limited resources. There was a lack of in-house E&L knowledge that meant this hefty workstream was not started early enough. This issue was escalated very high up and was in the spotlight at above-site leadership teams. A fast and effective E&L qualification approach was needed to keep the project on track.
Solution
The company used Fastnet to rapidly implement a science-based approach in a traceable GMP format, which enabling quality to perform facilitated reviews. The risk of leachables was significantly reduced by applying principles outlined in Margarian et al (2016). Only materials of constructions and surface areas of SUT located downstream of UFDF presented a risk to patient.
Result
The project was delivered in record time with limited resources. All involved received superb recognition for preserving the commercialization milestones of the product. The approach used would go on to be adopted at the global level across all sites.
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