TOUR INTERPHEX 2018 - abm-website … · NCARB, John Lyons, Paul Valerio 16 Tech Highlights from...

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Technologies Tours Continue to Expand

Tour Leaders Provide Tour Overviews and Insights

Tech Highlights from 2018 Tour Vendors

IPSTechnologiesTours: April 18, 10 a.m. and 1 p.m.

INTERPHEX 2018

TOUR GUIDE

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INTERPHEX 2018 IPS TECHNOLOGIES TOUR GUIDE 3

IPS WELCOME 2018

Here’s something you might not know: While this is our 8th formal year of the IPS Technologies Tours at INTERPHEX, we actually

started our tours more than 12 years ago. They might not have been so robust back in the day, but our mission was very simple: introduce our clients to new technology that would support their current or future manufacturing needs. We started small, with one or two clients usually focused on a singular area of expertise. As word got out, the tours gained popularity from clients wanting to learn about new technologies, and vendors wanting to showcase their new products. INTERPHEX witnessed the surge of interest from both attendees and exhibitors and proposed to formalize our tours, and make it part of the INTERPHEX experience. We broadened the spectrum of technologies and vendors from one or two specialty areas of pharmaceuticals to several tours focused on topics impacting the industry and game-changing, in some instances.

There are continually new products and processes being introduced every year in the industry to keep up with new scientific and technological advances, many of which are displayed at INTERPHEX. While vendors can explain the functions of their products, it can be challenging to determine why one product is better than another for an owner’s particular facility. That is where IPS comes in. We take great pride at keeping up with industry trends and developing innovative and customized solutions to fit a client’s need. In so doing, we have firsthand experience with the different types of products and know the ideal ones to select for each situation.

INTERPHEX provides a unique venue to facilitate this knowledge sharing opportunity. With INTERPHEX’s support, IPS provides a distinctive experience for trade show visitors and members of the pharmaceutical and biotechnology Industry. We bring knowledge and innovation to the show by:

• showcasing technical advances in equipment to the drug manufacturers on the tours;

• identifying the potential application of the innovations in the drug manufacturers current projects; and

• providing the drug manufacturers an independent SME’s perspective on the advantages of the innovation in managing their project’s risks through dialogue on the tours and at our booth.

We are very excited to be offering six new tours this year that include cutting edge, state-of-the-art technical innovations in each technical category.

The mission of the Technologies Tours remains true: Through our Knowledge, Skill & Passion, we share our technical expertise and project experiences while helping attendees navigate through the best performing equipment that could suit an owner’s manufacturing needs.

We are looking forward to seeing you at the show.

—Sterling G. Kline, RA Vice President-Design and Innovator of IPS Technologies Tours

A Note from IPS…

Sterling G. Kline, RAVice President-Design and Innovator of IPS Technologies Tours

4 IPS TECHNOLOGIES TOUR GUIDE INTERPHEX 2018

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TECHNOLOGIES

INTERPHEX

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5 Containment Band Reunion— Process Containment for OSD and Parenteral Manufacturing

IPS Tour Leaders: Sherry Chen, Sam Halaby, Paul Valerio

7 Tech Highlights from Participating Vendors: ChargePoint Technology Ltd., Extract Technology, Getinge, ILC Dover, LP, SKAN US, Inc., Solo Containment

8 Continuous Manufacturing Principles: Linking Unit Operations and Eliminating Intermediate Bulk Storage

IPS Tour Leaders: Theodore Cohen, MEM; Lonna Gordon; Mike Vileikis

10 Tech Highlights from Participating Vendors: Glatt Air Techniques, Inc., GEA North America, L.B. Bohle LLC, Pall Biotech, Asahi Kasei Bioprocess America, Inc.

11 Critical Utilities: The Lifeblood of Your Facility

IPS Tour Leaders: Daniel Colantonio, Todd Moesch, Brian White

13 Tech Highlights from Participating Vendors: Allegheny Bradford Corp, Holloway America, Sani Matic Inc., STAINLESS FABRICATION, INC., Budzar Industries Inc., Mar Cor Purification

14 Flexible Parenteral Manufacturing – Seed to Vial

IPS Tour Leaders: Jason S. Collins, RA, NCARB, John Lyons, Paul Valerio

16 Tech Highlights from Participating Vendors: Thermo Fisher Scientific, Pall Life Sciences, AdvantaPure®/NewAge Industries, Inc., OPTIMA Machinery Corporation, groninger USA L.L.C., Bausch + Stroebel Machine Company, Inc.

17 iCON™ – The Turnkey Facility of the Future Here Today. Are you iCON™ ready?

IPS Tour Leaders: Erich Bozenhardt, P.E., Tom Piombino, P. E., Peter Makowenskyj, Dennis Powers

19 Tech Highlights from Participating Vendors: Butler Manufacturing™, G-CON Manufacturing, Inc., AES Clean Technologies, Inc., MilliporeSigma, IPS-Integrated Project Services, LLC

20 The Track to Serialization: Solutions to Safeguard Your Products

IPS Tour Leaders: David Buynak, Kevin Swartz

22 Tech Highlights from Participating Vendors: METTLER TOLEDO, Adents, ANTARES VISION U.S.A., Optel Vision, WIPOTEC-OCS, Inc

All IPS Technologies Tours are scheduled for April 18, 10 a.m. and 1 p.m.

A special thank you to Pharmaceutical Processing for capturing the technical highlights of our tours, insight of our tour leaders, and recognition of the selected vendors.


Aging facilities in pharmaceutical manufacturing are

a topic of much concerned discussion in the industry and in world healthcare circles, especially where sterile and potent products are produced. Facility conditions and obsolete technologies pose risks to product quality and, therefore, supply of medicines to patients. Facility finishes, aging water systems, manual cleaning methods, and presence of gowned personnel in the aseptic environment performing open process manipulations all contribute to process risks and the potential exposure of potent products.

Deteriorating and dated systems are not the only factors working against aging facilities. The world outside those old walls is changing and moving forward. New knowledge and advances in process technology and facility design have improved greatly in the industry compared to the basis against which older facilities were designed. These advances then raise the bar for regulators’ expectation of quality. They observe older construction methods being

replaced with sealed modular wall systems that are more cleanable and less susceptible to environmental risks such as mold. Automation of processes is taking over manual steps in areas such as cleaning of vessels and parts, bio-decontamination of equipment, and automated loading of freeze dryers. Operations with fully gowned personnel performing aseptic manipulations adjacent to open sterile product in traditional Grade A clean rooms are replaced with those utilizing barrier systems. Isolator systems, in particular, are becoming simpler and more compact. Regulators expecting these advances in newer facilities organically raises the pressure on manufacturers operating aging facilities to replace or upgrade.

The improvements mentioned above for facility and process design represent advances in protecting sterile and potent products, and they are good for business from a compliance standpoint. Advances in process technology also present opportunities for better profitability due to increased capability. New systems

Leapfrog: An Opportunity for Sterile and OSD Product Manufacturers with Aging Facilities to Minimize Containment Exposure, Reduce Risk, and Become More ProfitableBy Paul Valerio

Paul Valerio, Director, Technology, IPS

CONTAINMENT BAND REUNION


Innovative.

Flexible.

Effi cient.

Flexible Modular Production System.

View the award winning and amazingly simple,

VarioSys® on the IPS Technology Tour.

And see the New BZV8110

Bin-and-Feed Hopper System.

Presented by Andre Zdunczyk,

Bausch+Stroebel Sales Manager.

www.variosys.com

April 2018

INTERPHEX New York

Booth #2505B

offer higher throughput and product yield through features like 100 percent in-process checking (IPC) and advanced dosing to utilize every drop of bulk product. In parenteral manufacturing, market trends toward specialized products have inspired creation of a new range of technologies capable

of providing flexibility to fill numerous components in one suite, including vials, syringes, and cartridges.

A compliant facility design coupled with advanced process technology creates capability to run efficiently with fewer process risks and deviations. That’s good business.

So, what does all this serious stuff have to do with Leapfrog? One form of “leapfrogging” in business is to profoundly advance in capability by taking advantage of progress already made by others. In recent years, impressive progress has been made in robust process containment and fill-finish process technologies in terms of performance and compactness. The ratio of opportunity to risk is more favorable than ever for manufacturers looking to progress their aging sterile and OSD product facilities. Robust systems are available to enable just about any product portfolio, offering new business opportunities and multiple paths to return on investment.

Opportunity awaits, yet it is not so simple to seize it. Many organizations are so focused on making their older facilities function well that there is little time to keep up with current technology. Once organizations decide to pursue upgrade or replacement of aging sterile and OSD product facilities, simply transferring old processes to new equipment might provide just a fraction of the potential gain. Perhaps the greatest challenge in looking outside those old walls is grasping what new technologies are available and how to apply them. Creating the most successful future possible involves product portfolio strategy and research in several areas, one of them being currently available and emerging process technologies. Internal research and leveraging support from qualified process solution providers and design firms will help lead to a much needed leap ahead.

ChargePoint Technology Inc.www.thechargepoint.com | Booth #3033

PharmaSafe® & VERIFi™ The ChargePoint PharmaSafe® valves ensure the safer handling of High Potent Active Pharmaceutical Ingredients (HPAPI), as well as other formulation ingredients, offering the highest levels of operator protection through validated containment per-formance. PharmaSafe® provides nanogram level containment performance and allows the user to maximize yield by transferring poorly flowing and high value product. ChargePoint® range of valves now include VERIFi™. VERIFi™ is wireless monitor-ing technology that communicates vital equipment performance data and provides an audit trail; allow-ing maintenance, health and safety, and compliance teams to make informed decisions to proactively manage maintenance programs.

Extract Technologywww.extract-technology.com | Booth #1835

Containnment Solutions Extract Technology’s containment isolators and downflow booths are designed to provide opti-mum operator safety for the specific OEL band required. Isolators can achieve less than 0.1 micro-grams/cubic meter while downflow booths can achieve less than 10 micrograms/cubic meter with barrier screens.

Getingewww.getinge.com | Booth #3133

Getinge Isolation Technologies for Parenteral Manufacturing Getinge Isolation Technologies include Rigid and Softwall Isolators used in the Aseptic Containment, Mixing and Dispensing, and Liquid Transfer for Parenteral and Oral Solid Dosage manufacturing. Our industry-leading DPTE® Alpha and Beta port products ensure a sterile and or contained transfer. Additionally, our industry expertise in providing customized solutions to the unique applications of our customers ensures successful projects that protect the product and the operators.

ILC Dover | www.ilcdover.com | Booth #2763

Flexible Containment for Nanogram Level ContainmentILC Dover will present a case study for high con-tainment of an OSD process with a Containment Performance Target of less than 30.0 nanogram/m3. The design concept for the process train con-tainment will be presented, including the SMEPAC testing method and results. The risks for contain-ment to the nanogram level are discussed and how these risks can be mitigated using best-in-class design and the benefit of a negative pressure sys-tem. Flexible containment systems are widely used in the pharmaceutical industry for HPAPI, including handling of ADC’s. The value proposition of flexible containment is reported, including low capital cost and ongoing savings from elimination of cleaning.

SKAN US, Inc. | www.skan.ch/en/ | Booth #3140

SKANFOG Material Airlock with NANOX CatalystThe New SKANFOG Material Airlock with NANOX Catalyst is an update to SKAN’s previous material airlocks that can efficiently decontaminate items entering or exiting a Grade A or Grade B zone. The system now uses the most efficient catalyst system in the industry with a patented process that provides fast cycles and easy facility integration, saving tens of thousands in ductwork and exhaust connections, fa-cility pressure balancing, and more. Sizes range from small shelf loading units to cart-based pass-through units and roll-in/walk-in decon chambers. Great for aseptic applications, biologics manufacturing, or con-tainment facilities. Fully validated and supported by factory-trained SKAN personnel based in the USA.

Solo Containmentwww.solocontainment.com | Booth #3661

Solo Single-Use Containment SystemsSingle-Use Isolators for Aseptic Filling: Solo has de-veloped the first fully disposable isolator to be used to manufacture a clinical batch within the regulatory framework.

TECH HIGHLIGHTS FROM PARTICIPATING TOUR VENDORS




CONTINUOUS MANUFACTURING

Formulation AdvantagesA tablet needs more ingredients than a capsule to keep the tablet structurally stable, reduce friability, and maintain the designated hardness parameters. The tablet also must include ingredients to help absorb the fluids of the gastrointestinal system so that it disintegrates easily to maximize the drug’s bioavailability. The dissolution and bioavailability of a capsule depend solely on the appropriate selection of the capsule materials. This simplifies the formulation inside.

Because capsules require fewer ingredients than tablets do, the manufacturing processes adapt perfectly to the design of a continuous manufacturing process. All ingredients are modulated (controlled introduction) into the blenders to achieve the appropriate product mix. Tuning of the feeders based on material micrometrics is one of the most challenging aspects of designing a continuous process and limiting the number of feeders associated with the process will greatly streamline

the development phase of the operations. Fewer ingredients going into a capsule blend means a simpler continuous OSD process.

Unit Operations AdvantagesThe majority of capsule formulations are processed via a direct blend operation, unless one is creating a time-release product that would require fluid-bed coating to create small coated beads. However, assuming a fluid bed would still be required, the unit operation of coating can definitely be eliminated. While this elimination provides some advantages to the facility design as far as energy, footprint, and logistics, the most intriguing advantage is how the elimination of coating is the most beneficial to a continuous manufacturing arrangement.

The objective of a continuous manufacturing operation is to arrange a series of close-coupled unit operations monitored by PAT devices between functions. This concept eliminates manual material handling, eliminates QC testing between functions, and

Continuous Manufacturing Principles: Linking Unit Operations and Eliminating Intermediate Bulk StorageWhy don’t more OSD Research and Development

Departments default to capsules instead of tablets

for new products?

By Michael Vileikis

Michael Vileikis, Director, Process Technology, IPS

greatly reduces the overall time of a production batch. However, when processing a tablet on an integrated continuous line, tablets must be removed from the continuous path and go through a batch coating process or be put in a holding pattern via surge storage to be processed inline by a semi-batch coater.

The issue with integrating a coating operation into a continuous product is managing relaxation time. Whenever a tablet is compressed, the material needs to rebound or relax. The plasticity of the product will allow it to compress under the force of the punch in the turret, and then once released, the product will expand depending on the material makeup of the formulation. While typically this is not an issue in a traditional batching operation, as there are hours to days between the compression operation and subsequent coating operations, in a continuous manufacturing arrangement the time for relaxation is minimal. Plasticity and relaxation timing will vary between products, making it difficult to streamline a coater into an otherwise continuous line.

By selecting a capsule delivery system as a default in R&D for new product, especially for organizations advancing into continuous operations, problems associated with coating can be bypassed completely.

Facility AdvantagesAs previously noted, the majority of capsule formulations are direct blend operations. Eliminating both fluid-bed processing and coating from operations significantly reduces footprint, as well as energy consumption. The reduction in building requirements

is not just seen in the clean room, but more substantially in the adjacent mechanical spaces. By eliminating fluid beds and coaters, the facility also will be eliminating multiple dust collectors, air

handling units, and potentially solvent absorption or abatement equipment. The trickledown effect as far as steam usage, chilled water usage, and electrical also results in smaller utility systems.

Capsule DisadvantagesThe major disadvantages of capsules are the potential for reaction of the capsule shell to the product, the limited sizes of capsule shells, and the limited look and overall lack of elegancy for the presentation of the product. Tablets can be made in various shapes and sizes, and delivered in numerous colors. Tablets can be engraved with numbers, letters, or images, allowing a company

to make their tablet unique and marketable. Another issue is that unless the capsule is banded, there are concerns with product tampering. Depending on the capsule, it can be slipped apart,

modified, and reconstructed easily with limited to no evidence suggesting tampering.

Final OpinionWhile there can be serious concerns regarding material interactions and the limitation of the fill volume in standard capsule shells, the potential advantages of streamlining unit operations, reducing footprint, and reducing energy consumption weight strongly against the potential disadvantages. There are significant savings to be gained in defaulting to a basic capsule formulation as a primary starting point for new products, and designing R&D and pilot scale production accordingly.

The objective of a continuous manufacturing operations is to arrange a series of close-coupled unit operations monitored by PAT devices between functions. This concept eliminates manual material handling, eliminates QC testing between functions, and greatly reduces the overall time of a production batch.



Asahi Kasei Bioprocess America, Inc.www.ak-bio.com | Booth #3735

Award-Winning Inline Buffer Dilution Technology Designed to fit within tighter space and budget constraints, our patented 3-pump and 5-pump IBD systems leverage process analytical technology (PAT) to generate precise and reproducible buffers for a consistent yield and recovery of your biolog-ic product. Buffer dilution and conditioning takes place simultaneously via a dynamic single-pass mixer featuring conductivity and pH feedback con-trol. Within 15 seconds from system start-up, you can produce high-quality buffers on demand from stock buffer concentrates and pH modifiers. Such efficiency, when combined with the “scheduler” function to enable production of multiple buffers, facilitates capture and polishing steps during con-tinuous chromatography.

GEA North Americawww.GEA.com | Booth #2421

ConsiGma™ Continuous Processing PortfolioGEA will be presenting several technologies including the ConsiGma™ Continuous Process portfolio for the production of OSD tablets on a continuous basis. The ConsiGma™ Unit receives API & excipient powders, and on one common platform,

blends, granulates, dries, and compresses the powder into tablets. With ConsiGma™ technology, no scale-up or tech transfer is required, as clinical samples and final products are produced on the same ConsiGma™ unit. Thus, “speed to market” is accomplished faster and at a significantly lower cost. GEA also will be presenting a wide range of

Liquid and Liquid Dosage technologies, including GEA Lyophilizers with Automatic Loading and Unloading (ALUS™) systems.

Glatt Air Techniques, Inc.www.glatt.com | Booth #2505A

L.B. Bohle www.lbbohle.com | Booth #3345

L.B. Bohle QbCon® Continuous Manufacturing SystemsL.B. Bohle ‘s technology advances in continuous pharmaceutical high shear wet granulation and (continuous) drying with the introduction of QbCon-®1.

Pall Biotech www.pall.com | Booth #2815





CRITICAL UTILITIES

Q. What specific systems are considered for critical utilities in the pharma environment?

A. The answer to this question will vary somewhat from one organization to the next. However, most will agree that critical utilities minimally include direct impact systems used for product formulation and compounding or for cleaning and sanitizing product contact surfaces. Examples include compendial water (WFI, PW, and HPW), Pure Steam, Clean-in-Place (CIP) systems, and systems used for the generation and distribution of Process Gasses.

Q. What are the various elements that need to be addressed when designing critical utilities in pharma?

A. Unlike most plant utilities, these systems need to meet the same rigorous criteria as the process systems they support. Those criteria extend directly from 21CFR Part 211 Subpart D, which states, “Equipment

used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.” While ambiguous, this statement casts a wide net and outlines the fundamental requirements for all of the equipment used in the facility. As direct impact systems, they are validated in the same manner as any product contact system.

Q. Do you examine and validate each part of the critical utility systems separately along the way, handle that as part of the integrated project, or both?

Critical Utilities: The Lifeblood of Your FacilityBrian White, Director Process Engineering,

IPS, offers insight to the various elements key

to critical utilities in pharma.

Brian White, Director, Process Engineering, IPS

Critical utilities minimally include direct impact systems used for product formulation and compounding or for cleaning and sanitizing product contact surfaces.


CRITICAL UTILITIES

A. Traditionally, every part of a critical system is “validated.” Precisely what “validation” means can vary somewhat for different organizations and different market segments. Many will argue that beginning in the 1980s and moving into the new century, the validation pendulum swung pretty far to the conservative side of the spectrum, often adding costs not offset by corresponding improvements to the integrity of the products being produced. For the last decade, the zeitgeist has been more centrist with the pharmaceutical industry

leaning toward a risk-based approach to validation. That said, it is important to ensure that every critical quality attribute (CQA) is identified, quantified, and verified in the context of the intended use. CQAs associated with the manufacture of injectable solutions may not be the same as those associated with the

production of small molecule APIs (active pharmaceutical ingredients).

Q. What steps are taken to monitor the environment to be certain that product quality is not adversely affected by a malfunction, even a minor one?

A. For some critical utilities, the CQAs are defined by the underlying regulatory basis. For example, the requirements associated with purified water are, in part, defined by the compendial monograph (i.e., USP, EP, JP, etc.) that outline

Conductivity Limits, TOC (Total Organic Carbon) Limits, and so forth. Other CQAs associated with that type of system will be specific to the intended use and could include attributes like pressure, temperature, or microbial limits. So measures such as the steps taken to monitor the environment will be specific to the intended use.

Q. Once critical utilities are properly functioning and validated, how closely must it be monitored during actual product production?

A. As with all other aspects of an owner’s validation program, the intensity of the monitoring program should correspond to the anticipated level of risk. Many critical attributes, like conductivity and TOC, are continuously monitored online. Other attributes, like microbial or non-viable particulates, may be sampled periodically based upon the practical limits of the corresponding test methods, risks associated with the intended use and an assessment of the impact of non-compliance.

Q. Can legacy systems successfully be incorporated into an overall critical utility design?

A. Absolutely! Legacy systems are a fact of life throughout the industry. The tried and true systems of yesteryear often have the advantage of a demonstrated history of compliance. As long as those systems remain reliable and the associated equipment remains serviceable and supportable, there is no overarching reason to invest in replacements. However, when valves, instruments, or other critical parts are no longer supported by the original equipment manufacturers, they can represent a meaningful threat to business continuity and should be considered for retirement.

The tried and true systems of yesteryear often have the advantage of a demonstrated history of compliance. As long as those systems remain reliable and the associated equipment remains serviceable and supportable, there is no overarching reason to invest in replacements.


CRITICAL UTILITIES

Allegheny Bradford Corporationwww.alleghenybradford.com | Booth #2445

Sanitary Shell & Tube Heat ExchangersWhether it’s a U-tube, straight-tube, or coil heat exchanger, Allegheny Bradford is the leading manufacturer of sanitary shell and tube heat exchangers. We have built a reputation for quality in the design and manufacture of heat exchangers for pharmaceutical, biotechnology, and other industries. As a recognized leader in the industry, we offer today’s most advanced stainless steel processing technology, along with a team of dedicated professionals committed to providing you with products that deliver unparalleled performance and dependability, along with the responsive customer service you need.

Budzar Industrieswww.Budzar.com | Booth #2163

Director Series Reactor Temperature Control Module The Budzar Industries Director Series Reactor Tem-perature Control Module, suitable for applications requiring a wide range of heating and cooling appli-cations with a single heat transfer fluid, achieves a temperature range of -85° to +200°C with environ-mentally friendly refrigerant. Available in sizes for 20 liters to 500-gallon reactors, the Director Series features stainless steel construction and a PLC control with Data Logging & Trending Software with Self Tuning for accuracy +/- 1°C.

VESSELS

Holloway America www.hollowayamerica.com | Booth #3510

Mar Cor Purificationwww.mcpur.com | Booth #3939

BIOPURE LSX WFIThe BIOPURE® LSX WFI System for pharmaceutical applications combines all of the components

required to expertly deliver and maintain validated WFI pharmaceutical grade water with significant up-front and operating cost savings for the end user. The base system is a compact centralized single pass RO-EDI system designed to produce WFI purified water grade. The BIOPURE LSX WFI System is designed to minimize energy consumption, while the automated heat sanitization process allows for greater bacterial control. This reduces the need for chemicals and leads to increased peace of mind and less down time.

Sani-Matic, Inc.www.sanimatic.com | Booth #2133

ASME BPE-Compliant GMP Cabinet WashersThe new PharmaCab SP Series is an automated, ASME BPE-compliant cabinet washer for pharmaceutical processes using glassware, filter housings, dedusters, scoops, hoses, valves, fittings, and other process parts that require a repeatable, validated clean. The pre-engineered design offering has three configurable models featuring different chamber dimensions: the SP333 (34”W x 34”D x 40”H), SP443 (48”W x 48”D x 40”H), and SP444 (48”W x 52”D x 48”H). It allows engineering consultants and pharmaceutical manufacturers to quickly select options for a fully defined cabinet washer.

Stainless Fabrication, Inc. www.stainlessfab.com | Booth #1958

SFI Pharmaceutical Processing Vessels Building stainless steel vessels of all sizes for the pharma industry is a big part of our business. We have the expertise to ensure the equipment we build meets customer requirements. From vessels for small batch processing to large field erected tanks, SFI builds them all. Production, finishing (including electropolish), and testing can be per-formed in this bay. SFI is ASME certified. We offer full documentation and FAT services. Inspections, modifications, and repairs also are available.



FLEXIBLE PARENTERAL MANUFACTURING

Q. Why is flexibility so important in this particular area?

A. Blockbuster large volume products are becoming fewer and farther between. In addition, previous large volume products are coming off patent meaning that generic drug manufacturers will start to produce mass quantities of these products more economically. What were once dedicated product facilities are now becoming multi-product facilities that are inherently less efficient. Multi-product facilities must provide a manufacturing environment that can produce the required volumes of drug products without causing cross contamination. This results in periods of time where production is idle so that changeover between products can occur. Product changeover affects two aspects of the facility: the production environment and the equipment. The production environment must have a rigorous validated cleaning procedure to ensure all product residue is removed. Where open processing occurs, it is even more critical

as the exposed product is vulnerable to contamination.

Different products may require different equipment depending on batch sizes, production steps, and container formats. As with the surrounding environment, the equipment also must be cleaned to a suitable level. Some items are broken down and cleaned in a remote washroom, while others are cleaned in place with automated systems. The bottom line, however, is all this cleaning, disassembly, and reassembly takes time and every minute spent in changeover is a minute the facility is not producing products. Many of the flexible equipment offerings featured on the tour are aimed at reducing turnover times.

Q. Has the surge of interest in biosimilar development created a growing need for new technologies in the next few years?

A. Biosimilars are not exact copies of their reference biologic products as production techniques are quite complicated and difficult to replicate. Producers of

Flexible Parenteral Manufacturing – From Seed to VialMany of the flexible equipment offerings featured on this tour are

aimed at reducing turnover times. We spent some time speaking

with Jason Collins, AIA, Process Architecture, of IPS, about some

of the tour highlights and why flexibility is key.

Jason Collins, AIA, Director, Process Architecture, IPS


biosimilars will need to develop their own versions of these products based on what is known when the biologic products come off patent. Manufacturers will surely be interested in new technologies that can speed their product development so they can bring them to market as quickly as possible.

Q. Considering the current drive for lower drug prices, particularly in the U.S., how does flexible parenteral manufacturing technologies help build efficiencies in processes?

A. The single biggest investment in a parenteral facility is the filling line. The equipment is so expensive that there is rarely room in the budget to have a backup filler and the equipment is expected to run efficiently every moment it is in operation. Large-scale filling lines are taking advantage of flexible components, which reduce the product turnover time, as mentioned above and keep the filler running as much as possible. We are now seeing a number of vendors who are taking a different approach. They are developing smaller, flexible, filling systems designed in a modular fashion to be interchangeable within a range of components. It is conceivable that a facility could have a number of these flexible filling lines so they can focus on smaller batches of many products based on demand, rather than waiting for the demand to be large enough to justify running their large volume machines.

Q. Does the manufacturing of single-use products present any unique challenges?

A. Even though single-use systems have been around for many years, there are

still challenges to adopting the technology. First, and foremost, are “extractables and leachables.” Drug producers must be sure the plastics and other materials used in single-use systems do not affect the safety or efficacy of their products. Studies with the single-use components should be incorporated into the development of new products as it is often more difficult to change the production techniques of existing products. Utilizing single-use systems also requires a consistent supply of quality materials from the single-use vendor. Owners must evaluate the facilities where these products are made to be sure standards are met and that the vendor is capable of meeting demand. Switching vendors would start the evaluation all over again.

Q. Within the flexible environment, how are changing mixtures and dosages handled to assure isolation and protection from cross-contamination?

A. Many of the flexible offerings that have direct product contact also are single-use systems. Since the component is thrown away, the risk of cross-contamination is greatly reduced. In addition, many

of these systems utilize close transfer elements that include aseptic connectors and RTPs (rapid transfer ports). Therefore, the product is protected from the surrounding environment and any external contamination.

Q. How does environmental control—temperature, air, etc.—factor into the process? Are any major technological advances on the way in this regard?

A. Many of the flexible filling systems on the tour feature isolator technology. With the aseptic environment contained in the isolator, the environmental control of the surrounding room can be greatly reduced. We also are seeing isolators used more and more in seed labs and inoculation rooms to reduce the possibility of containment at these critical initial production steps. These rooms were commonly the only aseptic suites found in a bio-facility. Now, they can be designed to meet the cleanliness levels of the surround production environments.

Vendors are developing smaller, flexible, filling systems designed in a modular fashion to be interchangeable.




AdvantaPurewww.advantapure.com | Booth #3055

Purity in Fluid Flow Systems® Positioned to anticipate and exceed the evolving needs of the pharmaceutical and biopharm industries, AdvantaPure® manufactures tubing and hose and molded BioClosure® container closure assemblies from platinum-cured silicone and AdvantaFlex® sealable and weldable TPE. The company focuses on Single-Use molded tubing manifold assemblies, offering benefits such as the elimination of leaks, entrapment, and contamination associated with barbed fitting tubing sets. AdvantaPass®, a clean room wall pass-through system, incorporates single-use disposable components to provide aseptic transfer of fluids between manufacturing suites. AdvantaPass offers complete isolation between different classes of clean rooms when passing multiple lines through a single wall portal.

Bausch + Stroebel Machine Company, Inc.www.bausch-stroebel.com/de | Booth #2505B

“VarioSys” Flexible and Innovative filling platforms

The Innovative and Flexible VarioSys® Production system fills high value parenteral biopharmaceuticals: Our team continues the development of this innovative aseptic filling system to stay on the cutting edge. A recent development was the capability to run the machine at full speed with 100% in-process-control (IPC) for the vial filling module. Our innovative and flexible bin and feed unit, type BZV8110, has been added to automate the component feeding via a Rapid Transfer Port (RTP). This innovative feature covers a gap in the industry for a simple, safe, and flexible way to add components to an aseptic filling line.

groninger USA LLCwww.groningerusa.com | Booth #3611

Flexibility by Design - groninger FlexPro Modular turnkey machine concept for the aseptic filling and closing of containers in small batches. Requirements for filling and finishing equipment have shifted from high-speed filling lines toward the processing of significantly diverse biotech products in smaller batches. This market trend requires new solutions for aseptic processing from machine building companies. groninger & Co. GmbH introduced the FlexPro 50,

a modular filling and closing system designed to process ready-to-use vials, cartridges, and syringes, as well as vials in bulk and trays. FlexPro 50 lines can be executed with manual or fully automated process steps depending on the requirements.

OPTIMA Machinery Corporation (WI)www.optima-packaging.us | Booth #3103

Latest Innovations in MultiUse Filling TechnologyOptima Pharma is excited to present its MultiUse filling and closing platform at this year’s INTERPHEX show. The MultiUse platform is an innovative machine solution focused on maximum flexibility for processing vials, syringes, and cartridges. A high degree of automation, robotic technology, and a state-of-the-art transport system encourages agile manufacturing and ultimate flexibility. The platform seamlessly integrates with Optima Pharma’s latest isolator technology for the highest product and operator safety. Optima Pharma is a member of Optima Packaging Group GmbH.

Pall Life Sciences

www.pall.com | Booth #2815

Thermo Fisher Scientificwww.thermofisher.com | Booth #3544



ARE YOU iCON™ READY?

Q. What factors prompted the move toward development of iCON?

A. iCON is a forward-looking response to an industry that demands collaboration and innovation to assist operating companies in getting products to patients. IPS and G-CON are consistently asked by their clients to deliver pre-engineered turnkey facility solutions that can be rapidly deployed, but also have flexibility in their design and capability to adapt to changing market needs. Both the pre-engineered and flexibility factors pull in technology, which makes perfect sense.

Our companies have a common vision for the future of manufacturing. Collaborating with the right partners, each of which brings their own complementary products and expertise, is the best approach. iCON is not the first turnkey facility solution to the market, but we feel strongly that it is the most sustainable one and brings significant value to drug manufacturers in ways that the other solutions of the past have not.

Q. How specifically can it introduce new efficiencies and cost savings within the typical pharma facility and environment? Are there any projected ROI metrics?

A. Because iCON is based on a pre-engineered design, the client can realize both cost- and time-savings during the engineering design phase. The closer they stay to the standard design, the lower the cost and the shorter the timeframe. Since both the cleanroom PODs and Butler Buildings are pre-fabricated in a factory, construction activities are taking place in parallel rather than sequentially allowing the project timelines to be further compressed. The onsite installation, assembly, and start-up can be performed much faster than a traditional facility construction project, allowing for validation activities to start sooner. The biggest impact to ROI for a client is typically the shorter timeframe for production start-up and revenue generation. Additionally, the ability to easily scale up or modify their operation within the iCON facility to adjust to changing

iCON™ – The Turnkey Facility of the Future Here Today. Are you iCON™ Ready?To learn just how to get iCON ready, we sat down for a Q&A session

with the Tour Leaders: Erich Bozenhardt, Process Manager, and Tom

Piombino, Senior Director, Process Architecture, both of IPS, and

Dennis Powers, Director of Sales Engineering, G-CON Manufacturing.

Erich Bozenhardt, Process Manager, IPS

Tom Piombino, Senior Director, Process Architecture, IPS

Dennis Powers, Director of Sales Engineering, G-CON Manufacturing



market needs also can provide significant value over pure purpose built facilities.

Q. Is it a technology or service that can be implemented within existing legacy systems?

A. iCON is intended to be either a greenfield or brownfield turnkey solution. It also can be implemented within legacy structures. For example, we are working on a cell therapy project within an existing space that was abandoned. The

modules were able to integrate within the existing structure and leverage existing central utilities.

As a first step, an Inceptioneering study can be conducted to determine the clients’ project requirements and assess their current available facilities, systems, and capabilities. Based on the outcome of the study, alignment with the iCON platform design can be determined and recommendations made to the client. In some instances, only certain elements of the iCON platform may be appropriate rather than the comprehensive iCON facility solution. For these cases, the iCON team will provide a recommendation for the products and services required to meet the client needs.

Q. What is the most unique characteristic of iCON?

A. There are many characteristics that distinguish iCON from its modular competitors and from more traditional stick-build projects. To highlight one, our introduction of “Hybrid Modularization” is high on the uniqueness list. When you look at the many facets of modular in the current construction market, you’ll find companies that really specialize in certain areas, but

will do others as needed. iCON really strives to combine the efficiency of those specialties and balance it with the use of regional craft labor in a hybrid approach. IPS and G-CON exist as thriving companies without iCON, but when we bring together our specialties in EPCMV and mobile modular cleanroom fabrication, things get really interesting. What client wouldn’t want to pool the most creative and efficient companies in the world together to deliver their project?

Q. How long did it take to design and implement iCON? Is it customizable?

A. iCON isn’t one thing so to answer the question around design duration, we’d have

to say that it will never be done. We are adapting the initial iCON platform for mAb processing to cGMP applications like Cell/Gene Therapies, Continuous Solid Dosage, Isolated Fill Finish, Weigh/Dispense, Solution Preparation, Wash Rooms, etc. Each project brings another product to market and as the world continues to adapt to iCON innovation, we expect the term “customization” will give way to our organically grown term, “optionalization,” which really conveys a philosophy of taking something off the iCON shelf and offering standard options.

Q. Are new iCON-related services under development for introduction over the next few years?

A. Yes is not a strong enough word to answer this question. Great minds produce great ideas, which in turn fuel new and creative implementation strategies. We have clients call us frequently asking if iCON can fit their application and/or have already come to a conclusion that it will and have ideas on how. It often feels a bit like Linux where the people who want to use it contribute as an open source, minus the free part of course. iCON as a mobile modular delivery product has unlimited possibilities and we have two or three more products being introduced in 2018. iCON as a service also is growing and as we look to the future, our vision is to serialize our project delivery process.

iCON™ is intended to be either a greenfield or brownfield turnkey solution.



AES Clean Technologywww.aesclean.com | Booth #1642

AES Pharma Wall and CeilingWithin the iCON™ delivery solution, the AES Pharma wall and ceiling system provides modular component support. AES elements are rapidly deployable in the mobile and modular facility platform. Our modular system is FM Global and ICC approved. The Pharma wall includes: UL raceways and has integrated doors, windows, coving, and other flush components. Surfaces are compatible with H202 and other stringent decontamination protocols. PVC cold welded panel seams eliminates caulk and provides a monolithic finish. AES Modular system reduces the project schedule and ensures compliance in every phase of the project lifecycle. We deliver beautiful cleanrooms as the end-result.

Butler Manufacturing™www.butlermfg.com

G-CON Manufacturing, Inc.www.gconbio.com | Booth #2429

The Turnkey Facility of the Future, Here TodayIn September 2017, G-CON Manufacturing and Integrated Project Services, LLC (IPS), introduced the biopharmaceutical industry to iCON™, a turnkey modular facility platform solution for biomanufac-turing. The iCON™ facility is unique in many ways; most importantly though, it can be established in less than a year and can be transformed from the development stage facility to clinical and commer-cial phases without interrupting existing processes.

IPS-Integrated Project Services, LLCwww.ipsdb.com | Booth #2132

IPS’ Integrated EPCMV Delivery: Minimizing Business Risk and Reducing Overall Schedule and Costs IPS is the pioneer in the application of single-source integrated EPCMV project delivery for technically complex facilities. We have developed, refined, and implemented a lean delivery model that addresses the entire project life cycle, from inception through validation to project completion. Working in a collaborative environment, we analyze and challenge every step of the project delivery cycle and apply unique ideas and solutions to eliminate wasteful and redundant processes. Our application of lean project delivery strategies are driven by design quality and effective control of costs and schedule, offering clients the predictable outcomes they come to expect while minimizing risk, reducing the duration from decision to delivery, and streamlining efficiencies.

MilliporeSigmawww.emdmillipore.com/end-to-end

Booth #2841

End-to-End Turnkey Modular MAb Manufacturing Platform BioReliance® End-to-End Solutions encompasses service and support for both emerging biotech and major biopharmaceutical companies that seek to accelerate drug development—from early clinical to commercial production. We operate our own in-house bioproduction facilities and convey our expertise to clients as they progress on their drug development journey, with an emphasis on single-use technologies and high-performance upstream and downstream systems. Together with iCON™, we provide turnkey solutions for the deployment of fast and efficient MAb bioproduction facilities.



THE TRACK TO SERIALIZATION

Q. How did you get your start in pharmaceutical technology and/or design?

A. I was strongly influenced to pursue a career in pharmaceu-ticals by my father—Dr. Eugene Buynak—who was an accom-plished research scientist with Merck for nearly 30 years. He was a virologist with Merck Re-search Laboratories (MRL) and was a key member of the team that developed several vaccines for Merck in the late 1960s and 1970s. He has his name on the patents for the Measles, Mumps, Rubella (MMR), Varicel-la, and Hepatitis B & C vaccines, all of which remain on the mar-ket today. My father traveled quite a bit to monitor clinical studies throughout the U.S. and lectured at global conferences about his research activities. I respected him greatly and wanted to follow his footsteps by working in pharmaceuti-cals. He unfortunately passed away in 1987 and never got the chance to see how truly influ-ential he was in my career.

Q. What steps do you take to stay on top of all of the changes and evolving technologies in pharma?

A. Given my interest in se-rialization, the keys for me are to read as much as I can

about it, go to seminars and conferences, and—perhaps most importantly—participate in trade and industry work groups. The work groups that I got involved with that greatly elevated my knowl-edge of serialization were the PhRMA (Pharmaceutical Research and Manufactur-ers of America) Serialization Work Group and the PDSA (Pharmaceutical Distribution Security Alliance). The PhR-MA Serialization Work Group, comprised of my serializa-tion counterparts at other pharmaceutical companies, provided an open forum to share progress and challeng-es. The work group served to develop an agreed aligned approach to meet serializa-tion requirements primarily in the U.S. though global legis-lation also was discussed. The PDSA was formed in 2011 as a consortium of supply chain partners—Manufacturers, Distributors, and Pharmacies plus their trade associations—who assisted Congress & FDA to draft the U.S. traceability requirements (DSCSA).

Q. How significant is the collaborative effort among manufacturer, distributor, and others throughout the supply chain when moving ahead with serialization?

The Track to Serialization: Solutions to Safeguard Your ProductsMeet David Buynak, Regional Compliance Manager, Serialization

Specialist, IPS. We learned a bit about his background, more about

serialization, and the key steps to a safe serialization platform.

David Buynak, Regional Compliance Manager, Serialization Specialist, IPS


A. Whilst you are developing a serialization strategy and build-ing your serialization capability, there is no real need to collab-orate or solicit inputs from sup-ply chain partners. That said, it makes perfect sense to engage and inform partners of what you intend on doing to meet/exceed impending legislative requirements. Although the truth is it has been the dis-tributors who have been most proactive in informing manu-facturers of their expectations for receipt and handling of se-rialized products. Each supply chain partner must understand the impacts of the legislation and invest in their internal systems and processes to meet compliance requirements. Col-laboration across the supply chain is absolutely needed as the deadline approaches to ensure uninterrupted supply of medicines to patients.

Q. What are the key steps required when implementing a safe and secure serialization platform?

A. Firstly, you need to recognize that serialization is only one element of what should be an overarching product security strategy for a manufacturing company. There are several key steps that are part of imple-menting a safe and secure serialization platform.

Understand the Legislative Requirements: This sounds very basic and logical, but you would be surprised at the lack of understanding that exists with serialization legislative requirements across the sup-ply chain further complicated by global serialization legisla-tion that have different coding

specifications, deadlines, and reporting requirements. It is industry best practice to have a single internal group that monitors and interprets market requirements rather than local marketing companies who may not have the expertise to assess properly the legislation. Though industry associations for each sector are very helpful to issue interpretations of serialization legislation, I recommend an internal legal review.

Assess the Impacts: Seri-alization is complicated and impacts many groups within an organization. Obtaining a capital cost estimate from your line level integrator for a serial-ization solution is a given, but there are many other impacts of serialization implementation that need to assessed and con-sidered…infrastructure, labeling, packaging processes, etc.

Develop a Serialization Strategy: Developing a seri-alization strategy is essential to ensuring that all change impacts are captured, consid-ered, and tracked to maintain patient access to medicines. This compliance-based strategy is a dynamic approach that can be flexible and agile to meet existing and emerging serializa-tion legislative requirements; it should be aligned with global-ly harmonized standards and practices.

Gain Senior Leadership Support: Without the engagement and support of senior leadership, there will be no serialization platform—period. Like any presentation to senior leaders it needs to be concise and clear, but with enough context for leaders to make a decision to authorize the serialization strategy. It is

also important to update senior leadership on a periodic basis regarding implementation progress, compliance, cost, and risk to ensure their ongoing awareness and support.

Form a Cross-Functional Team: This team needs to represent the impacted areas and consist of members who have some tactical decision-making power. As the serialization strategy owner, you own ‘the what & when’ and each site team needs to own ‘the how’ by developing the site implementation plan that aligns with its supply planning and demand commitments.

Build a Traceability Infra-structure: The IT impacts of serialization cannot be un-derestimated and need to be considered in a holistic manner across your internal and exter-nal networks. Serialization is putting a unique numbers on packs and cases, but traceabil-ity requires an infrastructure that can provision, transmit, exchange, store, and externally report serialization data and is integrated into your enterprise resource planning system. Engage with Providers & Partners: Engagement with pack line integrators, equipment manufacturers, and cloud data repository providers is important to the success of your implementation project. Line level devices are relatively cheap and readily available while pack line equipment like labelers and case packers are expensive long lead-time items. Supply partners and logistics providers need to be informed and aligned with manufacturers so they are prepared to receive serialized product and data.




Adentswww.adents.com | Booth #3461

The Most Powerful and Reliable Serialization and Traceability SolutionsAdents is fairly unique in the market in that we deliver end-to-end solutions to cover your serialization needs from level 1 to level 5. We work with CMOs and Top Pharma and our solutions are completely independent and can be integrated easily with other solutions on the market.

Antares Vision North Americawww.antaresvision.com | Booth #2571

Meet the World Leader in SerializationAntares Vision offers the most comprehensive and reliable serialization products. We provide a complete turnkey package from Level 1 (Devices) to Level 4 (Company interconnection). Our new software ecosystem, ATS Four, integrates the Antares Track System (ATS) architecture for a comprehensive, scalable and cost-effective solution to allow the widest connection capability for any traceability framework. Discover for yourself why we are the authority in serialization technologies.

Mettler-Toledo CI-Visionwww.mt.com/ci-vision | Booth #2141

A Complete Serialization System—T2620The T2620 enables complete carton serialization that complies with the requirements of the Drug Supply Chain Security Act in the USA, the Falsified Medicines Directive in Europe, and other worldwide regulations for Track & Trace. Its compact design

allows the T2620 to integrate easily into existing production lines in order to minimize disruption of the production process. A standardized design and the global presence of METTLER TOLEDO allow for fast delivery times to customers.

Optel Groupwww.optelgroup.com | Booth #2637

End-to-End Traceability SolutionsOPTEL GROUP is a leading global provider of traceability systems for diverse industries—namely, pharmaceuticals, medical devices, healthcare, agri-food, and natural resources. Join us at Booth 2637 and see our unique end-to-end traceability offering: item serialization, aggregation, data management, reporting software, warehouse management, and more. Let our Track&Trace experts show you how easy it can be to comply with regulations and how managing your data can help grow your business.

WIPOTEC-OCS, Inc.www.wipotec-ocs.com/en | Booth #1414

Simplifying Serialization and Aggregation of Bottles The WIPOTEC-OCS TQS-SP-Bottle machine displayed at our booth demonstrates a simplified serialization and aggregation approach to bottled medication. WIPOTEC’s approach features an integrated HMI display driven by an intuitive software program. This built-in software combined with our advanced 360-degree solid-state camera array will ensure secure product tracking without the need for an additional helper code on the bottle. Presenting the serialized bottles to the operator for manual aggregation in a controlled manner eliminates operator mistakes.


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We’ve Walked In Your Shoes.

Many of IPS’ subject matter experts come from the owner’s side.

• Advanced Asepti c Filling / Barrier Technologies

• API / Small Molecule Manufacturing

• Oral Solid Dosage (OSD)

• Biomanufacturing / Vaccines / Immunotherapies

• Potent Compounds and Containment

• Scale-up / Tech Transfer

• Criti cal Uti liti es / Uti lity Design

• Laboratories / Vivariums

• Risk-based C& / Serializati on

• IPD / Flexible & Lean Modular Constructi on

Areas of Expertise

IPS has the most knowledgeable professionals in the

industry who dedicate their careers helping our clients

bring product to market globally. From an overall business

and master plan, to the minute details of where to place a

light switch, IPS has the skills to execute any project.

IPS customizes each approach and is passionate

about integrati ng the right vendor for every aspect of

your facility. Join us during IPS Technologies Tours at

INTERPHEX 2018 where our Subject Matt er Experts

guide clients through the most innovati ve and relevant

biotech and pharmaceuti cal technology suppliers of today.

We Know What it Takes to Help You Succeed.

The Right People & Best Network

Consulti ng • Architecture • Engineering • Constructi on Management • Commissioning • ualifi cati on • Validati on

888.366.7660 • www.ipsdb.comKnowledge, Skill & Passion

For more informati on and to register for Tours, go to: interphex.ipsdb.com/interphex-2018 Visit Booth #2132

TOUR INTERPHEX 2018 - abm-website … · NCARB, John Lyons, Paul Valerio 16 Tech Highlights from...

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