TECH TANK at INTERPHEX
Mar 23, 2014
Many changes came to Interphex this year, and one of the most notable additions was the CRB Tech Tank forum, which kicked off the show on Tuesday morning.
The CRB Tech Tank included presentations from three top industry experts on trends and case studies from their respective fields.
THE KEY TO A SUCCESFUL FUTURE FLEXIBLE FACTORYMarc Pelletier PhD, Director of Strategic Biopharm Solutions Group at CRB, started the series with a presentation on biotech manufacturing and the impact of closed processing.
Encouraging attendees to pick up the new ISPE Baseline Guide for biopharma processing, Marc posited the idea that there is a great need for harmonized terminology as the industry moves forward. For instance, defining the term “closed system,” while currently used differently by many owners and operators, will need to be a widely accepted definition if the technology is to be used properly.
“Closed processing should be changing everything,” Pelletier said. “But it’s not! And it’s not regulation that is the hold up. We are not taking advantage of the power of [single-use] systems; we’re using old systems with new technologies.”
Pelletier closed by urging users to reevaluate their definitions of “closed system,” “controlled non-classified space,” and “a little contamination.”
“If we’re building the Chateau Versailles to house our single-use systems operation, we’re improperly using the technology,” Pelletier said. “But that’s what we’re doing – and it needs to change.”
UNDERSTANDING ORAL SOLID DOSE FORM (OSD) MANUFACTURING – THE PROCESS/EQUIPMENT AND TECHNOLOGYNext, Dave DiProspero, Senior Pharmaceutical Specialist at CRB, presented on the topic of OSD manufacturing, which provided an insightful and in-depth look at the different methodologies and options within the realm of OSD manufacturing.
“There are four main OSD process types,” began DiProspero. “1) High-Shear Granulation; 2) Wet Spray Granulation; 3) Direct Compression; and 4) Particle Coating. Selecting your process is based on your materials.” DiProspero explained how and why not all processes are suited for all materials, and how the process you use will directly affect how many unit operations are included in your process, which could range from just four to a lengthy twelve.
He addressed how other considerations beyond materials must be taken when designing an OSD process. For instance, the move toward improved ergonomics and decreased repetitive motion for operators will affect the equipment you select.
“Isolators always seem like a good idea, but adding one can take you from 10 minutes time to weigh out your API to over three hours. These are all things to contemplate,” he continued.
DiProspero closed his talk by offering some practical advice for executing successful projects.
“Integrating vendors early on will result in a better project, even if this is not a standard procurement procedure. Equally important is involving the operators in your project – getting their buy-in up front will offer pragmatic insight into the design choices you are making. And finally, more bidders are not always better. Everyone wants to get the best price for the technology, but if there is a company you already know and trust, they can save time and money on your project in the long run.”
THINK OUTSIDE THE VESSEL – IMPROVE YOUR OPERATIONS
The CRB Tech Tank series wrapped with a presentation from Niranjan Kulkarni PhD, Operations Specialist at CRB, who presented case studies on realistic improvements to make that will reduce expenses and increase operational efficiencies.
“Reducing cost can improve profitability – that sounds simple,” said Kulkarni. “But even in supply chains, keeping costs low while meeting high customer service level is a difficult problem to solve.”
Kulkarni continued to explain how lowering cost can be achieved in two ways: low unit cost and low transportation cost. Further, reducing variability (categorized as demand, supplier, process and flow variability) is a primary goal of Six Sigma methodology.
“Process and flow have their own curves and lead times. Six Sigma aims to reduce variability and lead time, while increasing consistency and eliminating defects. Further, by analyzing your activities, you can improve efficiency by reducing or eliminating non-value-added activities.”
Kulkarni shared multiple case studies and offered insight into making decisions based on improving efficiency, such as the difference between Just-in-Time solutions and a CONWIP strategy.
He closed by offering suggestions for tools that are easily accessible and often free for engineers and owners to use that can assist with implementing the strategies he discussed in each case study.
Each session included crowd participation with Q&A and was supplemented with online interaction via Twitter to give those who could not attend a live look at the thought-provoking ideas being shared by each presenter. It was a truly remarkable event, and CRB looks forward to continuing to share ideas with owners and vendors at future INTERPHEX-CRB Tech Tank events and beyond.