To open its inaugural educational conference, the International Society for Pharmaceutical Engineering (ISPE) anticipates a room full of attendees at Monday’s session focusing on Manufacturing Operations..  In response to the pharmaceutical industry increasing customer demand and the need to improve responsiveness to this demand, ISPE will present ways in which manufacturing operations can be made more economical, productive, efficient and quality-based.

According to Keynote Speaker Michael James, Site Leader, SAFC Biosciences, a Division of Sigma Aldrich, who will discuss the SAFC Filler Project, one way to increase capacity is to make better use of existing resources. New technologies aimed at producing more and better products also will receive their share of attention in subsequent sessions.

In “Application in Additive Manufacturing/3D Printing,” attendees will hear how additive manufacturing and 3D printing can save on manufacturing costs. This economic theme continues in “ASTM E-2500 Approach to Quality Risk Management: Part I” presenters will suggest that capital project timelines and reduced life cycle costs can result from its implementing ASTGM E-2500.

In Part II of the discussion on ASTM, Daniel Franklin,  Manager of Compliance Services at Integrated Project Services (IPS), suggests that ASTM E-2500 “makes perfect sense conceptually” and it is “depicted very efficiently and elegantly in a single, easy to comprehend illustration” within the Standard. “So, why haven’t more organizations adopted it?”  “Why have some companies tried to implement it and then abandoned it?” It may be that the risk-based approach was too risky. Results from a recent Benchmarking Study of ASTM E-2500 Implementation will be offered by Steve Wisniewski, Principal Consultant at CAI Consulting.

Improving processes, such as the compounding process and quality and efficiency improvements for tablet production will be examined for the variety of changes that can be implemented. In “Excellence in Quality and Efficiency,” Fabian Prehn, Head of Training and Consulting at Fette Compacting, will review how a firm increased OEE in tablet production from 28 percent to 60 percent, while Seiberling Associates Senior Project Manager Michael Byron and Seiberling Associates Project Manager Steve Welsch will ask “How can we convert an API process to be as susceptible to CIP/SIP operations for sterile processing as the biotech process?”  Byron and Welsch also will outline how the liquid and dry side processing of API compounds at times must be performed in a contained manner due to the use of solvents and the potency of the API. “These processes often use space hungry and expensive barriers to isolate soiled equipment from personnel to manage manual interactions with process equipment for maintenance and cleaning,” says Byron.

Automation is the topic in both “Convergence: The Connected Machine” and “Automation Project Ishikawa.” John Kowal, Director of Business Development at B&R Industrial Automation, separates “hype” from “practical” in industrial automation as applied to pharmaceutical processing and packaging in “The Connected Machine.” “In the context of pharmaceutical processing and packaging, practicality tends to be a straightforward matter of cost justification for increased machine connectivity, converging functionalities and accessing them from the human-machine interface,” says Kowal.

In discussing the “Automation Project Ishikawa,” Independent Biopharmaceutical Consultant Chinmoy Roy offers personal experience from the successful implementation of several large automation projects. He lays out risk factors in the process and techniques to overcome them. “Pharmaceutical companies are making a beeline to automate their manufacturing,” says Roy. “Consequently, regulatory agencies are gearing up to face the challenges of automated manufacturing by hiring inspectors who have the skills for auditing such systems.”

A two-part presentation focuses on EBR deployment and EBR implementation. In “EBR Deployment: Part I,” Chuck Krumwiede, Vice President of Business Development at Malcom Associates, looks at simplifying EBR/MES deployment and identifies what data to integrate to EBR and what SOPs need revision. In Part II, Krumwiede discusses a strategy for interfacing with other systems and continues to build a “roadmap” for implementing EBR effectively.

“Every system designer and end-user has to deal with many criteria for design and operation of biopharmaceutical pretreatment water systems,” acknowledges Shlomo Sackstein, Chief Operating Officer at Biopharmaz. “Chemical and Media-Free Pretreatment for Biopharma RO” will focus on identifying the issues plaguing water systems with reverse osmosis and defining the proper criteria of operation. Sackstein will describe a system with “no moving parts” and “without the need for rinses or backwashes.”

“Managing the Design of a Single-Use Facility” combines information from several case studies and SME experience that has “been there and done that” for next generation facilities. Speakers discuss ways to “…get outside of the project management box.” Jeff Odum, Director of Operations and Global Biotechnology Leader and Thomas Piobmino, Principal Process Architect, both from IPS, will describe new technologies offering greater value and efficiency, but also accompanied by new skill sets and different approaches to planning, development and operation.