For the bioprocessing and biopharmaceutical professional, this presentation discusses the topic: Is Standardization Possible in a Custom Single-use World. Key learning objectives are: 1. Understand why single-use design processes can become protracted 2. Understand how standardization can help to shorten the design phase 3. Discuss the opportunities for standardization in single use This presentation was first given as a live webinar by Guy Matthews to an audience of biopharmaceutical professionals from around the world in June 2016. 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.

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
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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
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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
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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
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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
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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)
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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
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9. Advantages of Working in a
Configuration (Standard) Space
Time Performance Quality
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Drawings
Samples
Implementation
Robust design
Known performance
Manufacturability
Build process
Materials
Documentation

10. Testing and Documentation
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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
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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

13. Sampling Assemblies
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14. Connectivity
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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
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16. How Could Standardization be Achieved?
Design Space
• Quality
• Performance
• Lead time
• Supply chain
• Demand
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Quality
documentation
Supply
chain
Performance
data
Manufacturability

17. Single-use Manufacturing Facility
Parker domnick hunter
Birtley, County Durham, UK
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18. What Does This Mean?
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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
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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
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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
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