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Trending Technologies in Sterile Product
Manufacturing Facilities
April 26, 2016
V1.0
Speakers • Principal Process Engineer • DME
Hite Baker Speaker/Moderator
• Project Design Manager • Merck & Co., Inc.
Parag Pande, M.S. ChemE Discussion Panel
• Principal Process Engineer, Vaccine Technology & Eng • Takeda Vaccines
John F. Barnes, P.E. MechE Discussion Panel
• Chief Operating Officer • Cook Pharmica
Ryan Hawkins Discussion Panel
• Director of Manufacturing Operations • Grand River Aseptic Manufacturing
Steve Nole Discussion Panel
• An INTERPHEX 2016 Technical Education Program. • Surveys
– Invited engineers, manufacturers, and other life sciences professionals like you to express views on the latest trends and technologies affecting our industry.
– Two Surveys, executed Q4 2015. • Biopharma Facility Modernization • Aseptic Manufacturing Tech Trends
• Whitepapers, issued April 2016. • Presentations with Distinguished Industry Panels.
• Industry Speaks: Transforming cGMP Manufacturing Facilities • Trending Technologies in Sterile Product Manufacturing Facilities
About DME Facility Focus
Survey Overview
Survey Participants (p5) AFFILIATION JOB FUNCTION
Triggers & Drivers: When Sterile Manufacturing Facility Modernization Becomes a Necessity
6
Why Change?
Sterile Manufacturing Modernization
Obsolescence
Reliability
Sustainability
Safety
Throughput
Flexibility
ROI/COGS
Quality
Regulatory Compliance
Project Drivers
Manufacturing Modernization
Risk Drivers • Product Quality • Regulatory Compliance • Obsolescence • Safety • Reliability
Opportunity Drivers • New Products • Throughput • Flexibility • Sustainability • ROI/COGS
Modernization (p7)
27%+17%+17%=61% What does this mean? Why so high? Should this change? Why/how?
Modernization – Manufacturers vs. Suppliers
Why such a large gap between manufacturers and suppliers?
Timing (p10)
Enablers: Technologies and Trends that
Provide the Best Modernization Solutions
Advanced Aseptic Technologies (p11)
Process Analytical Technology, unsure, etc.
Design Priorities (p21)
Capabilities (p26)
Technologies (p27)
Advancements (p29)
1
2
3
4
5 Ranked 1-5
1 = most frequent
Background Classification (p31)
Decontamination Agents (p34)
Long Term Strategy (p37)
Product Segregation (p39)
Summary
Transforming Facilities
Advanced Aseptic Processing Single-Use/ Disposable Technology
Barrier Systems Quality by Design
Isolators PAT (Process Analytic Technology)
RABS (Restricted Access Barriers) Risk Based Design
BFS (Blow-Fill-Seal) Ready-to-Use Primary Containers
Form-Fill-Seal Flexible Combi Filling Lines, vials, syringes, etc
Automation & Robots Real-time & Rapid Micro Monitoring
Closed Vial Processing Life Cycle Validation
Has there ever been a better time for our industry to focus on engineering issues and how to provide cost-effective sterile-manufacturing facilities that make the best use of available modern technologies to ensure that products of the highest quality are consistently manufactured?
For More Information
• Acquire DME Facility Focus survey whitepapers! – Available at INTERPHEX: DME booth #1666 – Available at www.dmeforlife.com/about-us/facility-focus
after INTERPHEX. • Contact Information
– Hite Baker – [email protected]
