Modularization Process in Project Delivery (Part III)

By Gene Martini, Design Vice President – IPS

If you read the first two installments of this series, you know that we are discussing the process of modularizing the delivery of a pharmaceutical facility. We want to avoid recursion; we want a process that builds in proven modularization concepts from the beginning.

The key to this process lies not in its steps but in the structure of the organization executing it. To optimize modularization, an Integrated Project Delivery (IPD) approach is required.

Traditional project delivery models separate the construction and CQV functions from the design function, as in design-bid-build, or restrict the owner’s involvement with the process, as in design-build. In IPD, all of the required skill sets are deployed on the project as they are needed and in collaboration, and if the entire project team has strong experience with Life Sciences Industry facilities, the combination of deep specialization and timely application yields the most efficient project execution.

In the IPD model, the owner and design professionals collect and document requirements and constraints and develop a conceptual design. On completion of the concept, procurement, construction and C&Q professionals are added to the team to develop and evaluate modularization options. The expertise applied by these team members is required to estimate the cost and schedule impacts of different options without incurring the cost to the project of fully developing those options. As the advantages of specific modularization approaches become apparent, the IPD team adjusts the course of the design and execution strategies to fully exploit these decisions.

IPD presents certain procurement and contractual challenges to the owner. However, throughout the course of an integrated project delivery, the owner is fully engaged, understanding the costs and benefits of each modularization decision, and fully supported by all of the expertise required to deliver the specified quality at the lowest possible cost and in the prescribed time.

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Bioprocessing Facilities: New Technologies are driving a Deeper Understanding of the Entire Process

Bioprocessing Facilities: New Technologies are driving a Deeper Understanding of the Entire Process

By: Tom Piombino, Process Architect – IPS-Integrated Project Services, Inc.

While most architecture in the world is devoted to creating environments for human occupancy, who is tasked with designing facilities that manufacture drug products to occupy humans?

If you have been immersed in the business and/or science of developing a new drug for the last 20 years and are fortunate enough to be thinking about a manufacturing facility for your new Phase III blockbuster biotherapeutic, trying to navigate the sea of starting point options may be your next big life challenge. Depending on the size of your organization, your experience and perhaps your geographical location, you may or may not have access to the resources needed to kick this effort off. As you embark on finding a firm to guide you through the process and design your facility, you might hear confusing terms like Lab Planners, AE (big A, little e or big E little a), healthcare/institutional architects, EPC, EPCM, EPCMV, Design Assist, Design Build… and the list goes on. All these terms may be relevant to your quest at some point, but if you really need to build an FDA compliant bioprocessing facility, there is a term that you may want to focus on first, Process Architect. Not the type that designs IT infrastructure or commercial office complexes or stadiums, but one with the highly specialized skills and experience required to design a facility to make drug products that are safe for one of the most intricate and sensitive communities in the world, the human body.

Billions of dollars are spent each year to research and develop new and improved therapies meant to defend, mend and extend human life. Once your therapy advances to a stage that inspires commercial development and investment, it’s critical that the facility where that therapy will be manufactured be designed to mirror the level of sophistication of its final human host. Therein lies the role of the Process Architect and “their process” to extract, understand and organize the volumes of requirements into a compliant matrix of logical compartments that emulate regulations, unit operations, safety and efficiency. A qualified Process Architect applies the appropriate regulatory requirements, engineering data points and process information available to make sense of your process, architecturally and operationally.

In the recent years, the art of bioprocess facility design and the experience that was needed to understand its many fundamentals was thrown against a wall and smashed into hundreds of small parts. To make the change even more profound, the parts move and more often than not, get replaced by many other parts that must be received, stored, cleaned, serialized and organized to avoid confusion and cross contamination. Flow through the corridors of a highly utilized facility has become a congested super highway of materials that were once hidden in “the process” and are now ushered by human hands to their interim destinations. The process architects for the next generation of manufacturing facilities will need to breathe in these new operating dynamics in order to engineer solutions that integrate hybridized platform bioprocesses and reduce the boundaries of clean travel. They will need to understand more than architecture and the published regulations; they will become experts on the technologies themselves.

At Interphex 2015, the subject matter experts and process architects at IPS will again be organizing technology tours to assist you with where to start your project. They will provide introductions to the many new technologies in bioprocess that are shaping future manufacturing environments for drugs that will occupy humans.


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Going with the Flow: Ensuring Integrity of Single-use Systems

Helene Pora, Vice President of Single-Use Technologies

Going with the Flow: Ensuring the Integrity of Single-use Systems

Single-use technologies for formulation and filling have revolutionized the clean manufacturing of small molecule and biologic pharmaceuticals, cutting costs and making production lines simpler, safer and more cost effective. However, these single-use systems can be damaged during storage, installation or use. To protect the end users, and give them confidence in the system, manufacturers need a simple, robust and reliable point-of-use test, confirming that there are no leaks before and/or after use.

There are a number of key user needs for a point-of-use leak test:

  • It needs to be simple to fit and must maintain the sterility of the system
  • It should be fast, so that it doesn’t hold up the manufacturing process
  • It should have a small footprint, so that it does not affect the layout of the production line
  • It should be flexible, in order to be able to test all configurations of systems
  • It should be validated and comply with CFR21 part 11 for audit purposes

Pall’s Palltronic Flowstar LGR test instrument, specifically designed for use in the vaccines, biotech, and pharmaceutical markets, meets all these criteria. It allows true point-of-use leak testing of single-use systems up to 200 L, including testing the integrity of the filters within the system, in only around 15 minutes. It is small and easy to use, and can be connected into the single-use systems via Stäubli fittings without breaching the sterility, and without the risk of additional handling.

The flexibility of the Palltronic Flowstar LGR test instrument means that it can test single-use systems with and without biocontainers, using air or nitrogen (for oxygen-sensitive applications). Their different test pressure increases its sensitivity, with high-pressure tests for simple tubing sets, and low pressure for 3D and 2D biocontainer systems. Finally, the test instrument is fully validated and CFR 21 part 11 compliant with a full audit trail. It allows end users to test endless configurations of single-use systems and filters, with a single test device.

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Hydrogen Peroxide Vapor as a Utility

Art Papineau
Product Manager | VHP Solutions
STERIS | Life Sciences | Capital Equipment Solutions

Choosing the correct biodecontamination method for your facility, isolator, decon chamber, etc. can be challenging for even the most knowledgeable and experienced personnel given all of the products available on the market today. Products ranging from formulated chemistries to chlorine dioxide to hydrogen peroxide with delivery methods encompassing manual, mobile, and integrated.

Since, hydrogen peroxide vapor’s introduction to the market more than 25 years ago by STERIS Corporation, the technology has continued to evolve over time to tackle new applications and markets. In pharmaceutical manufacturing, the technology was first applied to filling line and sterility test isolators. In a recent International Society for Pharmaceutical Engineering (ISPE) meeting, it was stated that 95+% of all filling line isolators utilize hydrogen peroxide decontamination technology for sterility assurance. With the technology’s acceptance in these critical applications, the technology has quickly evolved to biodecontamination of rooms and complete facilities.

Hydrogen Peroxide Vapor as a UtilityToday, hydrogen peroxide vapor technology can be deployed as a utility to be used in a prophylactic manner versus event response. As a utility, the technology can be directly integrated into isolators, chambers, and material pass through enclosures as well as deployed as part of a building management system for room and complete facility biodecontamination.

Whatever your need, whether mobile or integrated, hydrogen peroxide vapor technology has a solution!

To learn more about pharmaceutical applications of hydrogen peroxide vapor technology, please click . . .


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Multi-Component Kit and Device Assembly and Packaging

By: Kevin Swartz, Sr. Engineer – Packaging SME; Len Pauzer, Sr. Process Engineer; and Tina Gushue, Process Engineer – IPS

As the medical field develops unique delivery systems and novel drugs, it creates new challenges for the industries that support them, such as packaging companies. Every year pharmaceutical companies are making breakthroughs in finding improved methods of delivering medicines to patients.  An example of this is the increase in inhaled delivery systems for flu vaccination and some types of diabetic drugs which are assembled into kits. These new delivery systems require a unique packaging and assembling process that needs to be built. The need to package, inspect and material handle these products will only increase over time.  This trend challenges the manufacturers of packaging and inspection equipment to assemble these products for delivery to the market in a safe and efficient manner.

Equipment vendors are responding to these challenges with custom equipment designs with more flexibility. They are introducing technologies such as multi-axis robots, which are easily programmable and flexible, to deliver components to the equipment. They are also configuring custom hoppers and conveying systems for orientation and presentation to these robots.

The orientation of these components within a kit or device is of the utmost importance.. Inspection systems and checks must be in place to verify components are present, properly oriented, and placed into the correctly designated space. Multiple inspection stations may be needed on a piece of equipment to verify that devices with many pieces are not rejected due to a presented component being missing or misoriented. New generation equipment will present the next properly oriented component to allow the device/kit to be completed rather than rejected.

At the completion of each device/kit, an overall inspection should be completed as a final quality check before secondary packaging operations. For example, device may be cycled to verify proper function before leaving the assembly equipment, or it may have one final vision or checkweigh inspection.

The new challenges being presented by the medical industry are being met by equipment manufacturers with new and innovative technology and design. Interphex 2015 will showcase the best of these equipment manufacturers and allow you to interface with them to discuss your upcoming applications.


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A Multinational Vaccine Company Reduces Footprint and Cost with Pall Resolute® Linear AutoPak Chromatography Columns (Case Study)

David Johnson, Global Product Manager

Reduced packing success rate caused by operator error or a shortage of experienced operators is a major risk to the successful completion of the packing, unpacking and cleaning of process-scale chromatography columns. Coupled with expensive media wastage from traditional packing methods that require an excess in the slurry tank, it is obvious that a solution is sorely needed to address the challenges around downstream column chromatography.

A Multinational Vaccine Company Reduces Footprint and Cost with Pall Resolute® Linear AutoPak Chromatography Columns (Case Study)Pall worked with a multinational vaccine company to develop a solution to these issues; previously reliant on paper-SOP-driven packing for its global operations, the company realized that large savings could be achieved both in time and money through the automation of column packing. Using the Pall AutoPak solution, the company moved to fully automated packing and it projects increases in the packing success rate from 62% to 99%, combined with a reduction in labor costs for packing and unpacking operations of 31% in one site, and 41% in another site.

Maintenance and cleaning costs are also lowered because there are no extra pumps or packing skids required. And because the new columns have a smaller cleanroom/storage footprint, they deliver more space in tight cleanrooms.

The adoption of this technology as a global platform also ensures a consistent geographical approach, making tech transfer much easier.

This new generation of automated packing systems provides automated sequences that ensure reliable and consistent operation. The fully automated approach enables packing to be accomplished by any operator, thus eliminating error and reducing the dependence on key operators. In addition, the ability to use all of the slurry in the tank means savings can be achieved in overall sorbent consumption. In terms of equipment safety, the added benefit of multi-axis piston movement delivers monitoring and control functionality that is missing in single-actuator designs. All in all, the new generation of automated packing systems can enable biopharmaceutical manufacturers to produce a higher-quality product at a lower cost.

To learn more, please visit:


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Clinical Dosage Form Development or an Early Approach to Achieve Peak Sales

Courtesy of Somma Tech Consulting Company

Clinical Dosage Form Development or an Early Approach to Achieve Peak Sales Step #1

Pharmaceutical Development continues to present many fundamental challenges when dealing with promising drug lead opportunities. This is a factor across all therapeutic areas from Central Nervous System (CNS) to oncology. In an effort to design new molecular entities which are increasingly effective while minimizing unwanted side effects we at times create drug compounds which are poorly soluble or are unstable and difficult to handle during manufacture.  Continue reading

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