Is Standardization Possible in a Custom Single-use World | Parker domnick hunter
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The presentation by Guy Matthews discusses the challenges and benefits of standardizing single-use technology in bioprocessing. It highlights how customization can lead to inventory management issues, increased costs, and longer lead times, while standardization can reduce cycle times and improve robustness of systems. Ultimately, the document emphasizes that while customization is prevalent, standardization is crucial for the efficient growth of biopharma production.
Is Standardization Possible in a Custom Single-use World | Parker domnick hunter
- 1. Is Standardization Possible in a Custom Single-use World? Guy Matthews Market Development Manager Parker domnick hunter, UK
- 2. Learning Objectives • Understand why single-use design processes can become protracted • Understand how standardization can help to shorten the design phase • Discuss the opportunities for standardization in single use 2
- 3. About the Presenter Guy Matthews has worked in the biopharm industry for the last 20 years during which he has been involved in many projects implementing single-use technology in bioprocessing. Guy now works as Market Development Manager for Parker domnick hunter where he is focused on bringing Parker's expertise in motion and control to bioprocessing. This presentation was first given as a live webinar to an audience of biopharmaceutical professionals from around the world in June 2016 3
- 4. Single-use • Faster • Design and build • Turn around • Validation • Environmental Impact • Less water • Les power • Lower carbon • Smaller • Reduced utilities • Reduced holding tanks • Flexibility • Product Safety • Cross contamination • Containment • Reduced COG’s 4 Faster • Design and build • Turn around • Validation Smaller • Reduced utilities • Reduced holding tanks • Flexibility Environmental Impact • Less water • Less power • Lower carbon Product Safety • Cross Contamination • Containment Reduced COG’s
- 5. What has Been the Message From Single-use? Design exactly what you want and what you need for each process 5 What has this lead to? • One company with >2000 different assemblies • Inventory management issues • Longer lead times • Quality challenges • Higher costs • Longer implementation times
- 6. Why is Customization a Challenge? Vendor • Gamma stability • TSE/BSE (EMEA 410-01) • USP 88 • Expiry date • Supply chain • Manufacturing capabilities • Inventory management End-user • Design / testing time • Training • Inventory • Lead times • Incoming testing / review 6
- 7. The old View of Customization • Any customer can have a car painted any colour that he wants so long as it is black (Henry Ford) 7
- 8. Configuration and Customization • For general use • Built by many people • Standard parts/process • Easy to maintain • Understood • Very specific function • Built by one person • Lots of bespoke parts • Maintenance: full time • Expertise and past knowledge 8
- 9. Advantages of Working in a Configuration (Standard) Space Time Performance Quality 9 Drawings Samples Implementation Robust design Known performance Manufacturability Build process Materials Documentation
- 10. Testing and Documentation 10 Criteria / test Standard Comments Endotoxin <85> USP <85> How to collect a sample, rinse volume Particulates <788> USP <788> How to collect a sample, rinse volume Sterility ISO 11137/ AAMI or Gamma Exposure to >25kGy Safety test USP <88> Class VI Material suitability USP <661> Storage containers PET/PETG/heavy metals Animal Origin EMEA 410-01 rev Visual Inspection Vendor specific Against what criteria Critical Dimensions To Vender Specification Against what specification Gamma Irrad. >25 kGy & cert. Expiry date Based on vendor testing Quality systems cGMP, ISO 9001, ISO 13485 Statement Production Processes Vendor statement Based on validation Leak/integrity ?? Vendor test Shipping test ISTA / ISO/ ASTM Vendor specific
- 11. Endotoxin and Leak Testing 11 Supplier Endotoxin Testing Leak Testing A Monitoring Component testing B Batch release System test C Process validation Component testing D Process validation Pressure claim
- 12. Where Could Standardization be Applied? 12 System Complexity Single-UseAssembly StandardizationLevel
- 14. Connectivity 14 Pros. Cons. Quick to use Not robust due to tear drop shape Round shape creates and better seal Requires validated equipment for sealing Plastic piece Requires a skilled operator to use these devices Leak proof Expensive
- 15. Is Standardization Possible? • Yes and history proves it 15
- 16. How Could Standardization be Achieved? Design Space • Quality • Performance • Lead time • Supply chain • Demand 16 Quality documentation Supply chain Performance data Manufacturability
- 17. Single-use Manufacturing Facility Parker domnick hunter Birtley, County Durham, UK 17
- 18. What Does This Mean? 18 72 hrs (industry experience 14+ days) <1 week (industry experience 2+ weeks) 8 weeks (industry experience 12-20 weeks) Stage 1: Drawing Stage 3: Finished Product Customer Stage 2: Samples
- 19. Standardization Opportunities • For complex single-use systems • Standardization will reduce cycle times • Standardization will result in more robust systems • For less complex single-use systems • Standardization opportunities reply on components, but not in design due to end user / process specific requirements still need to be meet • Standardization offers potential COG‘s saving 19
- 20. Summary • Single-use is the key enabling technology for biopharma production • To continue the growth in biopharma that single use supports standardization is essential • The end user owns the process, while the vendor is responsible for the functionality and supply of assemblies 20
- 21. Contact Details North America: +1 877 784 2234 ROW: +44 (0)191 410 5121 dhprocessinfo@parker.com www.parker.com/dh-bioprocessing https://www.linkedin.com/company/ bioprocessing-and-pharmaceuticals 21