ISPE CASA 2018 Technology Conference 13 MAR 2018

ISPE – CASA - 2018 Technology Conference 13 MAR 2018

THE CHALLENGES & TRIUMPHS OF BFS SUCCESS IS AT HAND

Presenters Earlene Gibbons Senior Director, Operational Technology, Local Pharmaceutical Company in RTP Ingrid Marshall Project Manager, Avid Solutions, Inc. Connecting Pharmaceutical Knowledge ispe. org

WHAT IS BFS

WHAT IS BFS BLOW - Forms the container using a resin and mold

WHAT IS BFS FILL – Aseptic fill of container

WHAT IS BFS SEAL – Aseptic fill of container

WHAT IS BFS IN ONE MACHINE!

• Multi-step continuous process in one sterile machine • Produces small (. 01 m. L) to large volume liquid filled containers Connecting Pharmaceutical Knowledge ispe. org

BLOW FILL SEAL BENEFITS • STERILITY • -STUDIES OF PERFORMANCE BFS VS TRADITIONAL • FLEXIBILITY (TYPE, SIZE) • REGULATORY CONSIDERATIONS • STANDARD OF QUALITY • PRODUCT PERFORMANCE • DIFFERENT TYPES OF RESINS (FOR DIFFERENT TYPES OF PRODUCTS) • ECOLOGICAL • RESIN IS RECYCLABLE

BLOW FILL SEAL BENEFITS SAFETY • BREAKAGE • CONTAMINANTS • NO PRE-WASHING • RESIN IS STERILE • MADE, FILLED & SEALED IN ONE SEQUENTIAL OPERATION • NO CONTAINER STORAGE BEFORE FILLING • “MUCH LOWER FREQUENCY (ON-TENTH) OF CONTAMINATED MEDIA FILLS COMPARED TO CONVENTIONAL PROCESSES” – 7. B. LJUNGQVIST ET AL. , PDA J. PHARM. SCI. TECHNOL. 60 (4), 254– 258 (2006).

LOGISTICS • TRANSPORTATION OF RESIN ONLY • STORAGE OF RESIN ONLY • NO SPECIAL CONSIDERATION FOR STORAGE OF RESIN • COST OF SHIPPING PRODUCT IS SIGNIFICANTLY REDUCED • BREAKAGE

BFS Expanding the usage of an OSD facility was risky. Why? Design challenges – new disciplines, new concepts, new Utilities Expansion – No WFI Building Renovation Control system & SCADA architecture Connecting Pharmaceutical Knowledge ispe. org

WHAT ABOUT THE E-STOP

BE PREPARED TO TALK ABOUT THINGS FOREVER THAT HARDLY MATTER THERE’S A SIMPLE SOLUTION USE COMMON SENSE DON’T BE AFRAID TO START OVER STOP FIGHTING SOMETHING THAT WILL NEVER WORK GET AN EXPERT Connecting Pharmaceutical Knowledge ispe. org

SECRETS TO SUCCESS PLANNING, PLANNING HAVING TIME TO DESIGN BEFORE THE SCHEDULE DEMANDS A SOLUTION PROCESS KNOWLEDGE SOLUTION PLANNING CONTROL SYSTEM & SCADA ARCHITECTURE – HAVE A PLAN CONTROLS SYSTEMS ARE COMPLETE BEFORE MECHANICAL COMPLETION DOCUMENTATION COMPLETION AFTER CONTROL SYSTEM COMPLETION DOCUMENTS APPROVED BEFORE COMMISSIONING Connecting Pharmaceutical Knowledge ispe. org

COST OF CHANGE

COST OF CHANGE THE COST MAGNIFIES AS TIME PROGRESSES

THE COST ESCALATION - WHY IT DEPENDS ON THE STAGE WHY’S • EFFECTS EVERYTHING THAT CAME BEFORE & THE DOMINO EFFECT • LEAD TIMES FOR EQUIPMENT • UTILITIES INFRASTRUCTURE • CONTROL SYSTEM • PENN STATE UNIVERSITY STUDIES SHOW 10 X MULTIPLIER OF COST COMPARED TO IF DESIGNED UP FRONT Connecting Pharmaceutical Knowledge ispe. org

LESSONS LEARNED

LESSONS LEARNED The importance of the basis of design • Foundation of the project • Functional design • Define connections between systems

LESSONS LEARNED Importance of choosing the right integrator

LESSONS LEARNED Importance of the team • Skill sets • Same objectives for success • Working together toward the same goal

QUESTIONS Connecting Pharmaceutical Knowledge ispe. org

THANK YOU