The Value of Attending the Interphex Conference

Courtesy of Whitehouse Laboratories: Booth: 2057

When I started my career in the pharmaceutical industry too many years ago, tradeshows were a necessary part of the process and frankly I dreaded attending them. The days were long and drawn out and I never felt a very strong return on investment from all the time and expense they required. This is primarily why Whitehouse Laboratories did not regularly attend these types of events. However, in 2014, I conceded and let our management team  schedule a few trade shows as a means to visit with existing clients and industry partners as well as meet potential new clients. I must say the tradeshow world has improved over the last few years.  The largest and most well-known show we participated in was Interphex held in New York City Last April. Having worked the floor for a few days, I was able to see many long time clients and spend quality time with some of our key vendors, suppliers and partners.  In this article I will share with you my three key observations as to why Interphex is a must attend event and I hope, with my encouragement, I will have the chance to see you at the New York Show on April 21st through the 23rd.

Observations Number One: It was downright fun to see what the client actually looked like. Over the years I have developed a number of phone-based friendships with clients from across the country (and in some cases the world) that I have never met in person. As Whitehouse Laboratories has my picture posted on the website, clients know what I look like. At Interphex 2014 I met seven different phone friends in person for the first time. In all seven cases, the client looked much better than I imagined. These in person meetings only strengthened the already friendly relationship we had mutually built.

Observation Number Two: The overall crowd attending the exhibit hall was friendly and accommodating. A number of existing and potential new clients actually sought our Whitehouse Labs and took the time to visit our exhibit. Going back to my old time pharma tradeshow days, this was not always the case. In pointing this out to a few attendees, many were quick to state that the educational value of these shows has seen much improvement. In many cases, people were attending to hear a specific speaker or learn about a new technology. Overall, my assessment is that the educational component is now put at the forefront and the exhibit hall has taken a back seat. As a result, the attendance has grown (they expect 12,000 industry professionals for this year’s show) and attendees are walking away with new and improved knowledge.

Observation Number Three: While the true education is gained in the actual speaking events, do not short change what can be learned with a stroll through the exhibit hall. For me personally, I was able to spend valuable time with some of our key partners like Lighthouse Technology, Package Technology Incorporated and Genesis Packaging. I was able to see first-hand some of the new instruments they are developing and had the chance to meet other team members who I do not normally interact with. In addition, I was able to make connections for potential new partners to work with and learn about other companies out there that serve common industries. On the vendor side, I actually came across a new supplier for stability chambers and a new instrument for oxygen permeation testing. By the end of 2014, as part of our capital reinvestment plan, we made significant purchases from both vendors.

Coming full circle, my personal view of the value of trade shows, like my age, has grown. Whitehouse Laboratories left Interphex with three key takeaways:

  • We solidifies existing client relationships
  • We met 237 potential new clients – many of them now actual clients
  • We learned a lot about what is new and out there in the industry

I hope my words of encouragement are enough to inspire to take part and visit NYC for a few days in April. Prior to attending, I encourage you to visit www.whitehouselabs.com and take a peek at my picture – when you come to the booth you will know who I am.

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Filling Methods

Courtesy of Cozzoli Machine Company

Developments in filling technology have come a long way. Innovations in single-use systems, multi-function design and machine flexibility have contributed to equipment design. And regulatory compliance and serialization concerns have also impacted machine innovation. Despite these advances, the methods used for liquid filling are still basically the same. The main consideration is what pump type is best suited for your application.

A good equipment manufacturer will have resources to help you determine which filling equipment is appropriate for your project. Depending upon your product, production speeds, and space conditions your manufacturer will ideally provide you with machinery that is tailored to your needs.

Time pressure filling is accomplished by controlling the flow of the product through the tubing. The product stays in the manifold that feeds the tubes. A computer calculates the product flow time needed based upon manifold pressure, nozzle size and target fill volume

Time pressure filling is accomplished by controlling the flow of the product through the tubing. The product stays in the manifold that feeds the tubes. A computer calculates the product flow time needed based upon manifold pressure, nozzle size and target fill volume

 

Time pressure filling is accomplished by controlling the flow of the product through the tubing. The product stays in the manifold that feeds the tubes. A computer calculates the product flow time needed based upon manifold pressure, nozzle size and target fill volume.

 

 

 

 

 

Piston fillers are ideally suited for filling a diverse range of products. These fillers are ruggedly designed yet precision built for long trouble-free operation. Product viscosities may range from 1 to 100,000 centipoises and above.

Piston fillers are ideally suited for filling a diverse range of products. These fillers are ruggedly designed yet precision built for long trouble-free operation. Product viscosities may range from 1 to 100,000 centipoises and above.

 

Piston fillers are ideally suited for filling a diverse range of products. These fillers are ruggedly designed yet precision built for long trouble-free operation. Product viscosities may range from 1 to 100,000 centipoises and above.

 

 

 

 

With peristaltic pump fillers, nothing but the tube touches the fluid, eliminating the risk of the pump contaminating the fluid or the fluid contaminating the pump. The complete closure of the hose, which is squeezed between a shoe and the track, gives the pump its positive displacement action preventing backflow and eliminating the need for check valves when the pump is not running.

With peristaltic pump fillers, nothing but the tube touches the fluid, eliminating the risk of the pump contaminating the fluid or the fluid contaminating the pump. The complete closure of the hose, which is squeezed between a shoe and the track, gives the pump its positive displacement action preventing backflow and eliminating the need for check valves when the pump is not running.

 

With peristaltic pump fillers, nothing but the tube touches the fluid, eliminating the risk of the pump contaminating the fluid or the fluid contaminating the pump. The complete closure of the hose, which is squeezed between a shoe and the track, gives the pump its positive displacement action preventing backflow and eliminating the need for check valves when the pump is not running.

 

 

 

 

 

Diaphragm pump fillers are appropriate for corrosive chemicals, abrasive materials and delicate liquids (blood, insulin, and plasma). This completely enclosed system eliminates air bubbles on small fills and features accurate repeat fills.

Diaphragm pump fillers are appropriate for corrosive chemicals, abrasive materials and delicate liquids (blood, insulin, and plasma). This completely enclosed system eliminates air bubbles on small fills and features accurate repeat fills.

 

Diaphragm pump fillers are appropriate for corrosive chemicals, abrasive materials and delicate liquids (blood, insulin, and plasma). This completely enclosed system eliminates air bubbles on small fills and features accurate repeat fills.

 

 

 

 

 

 

For vacuum powder filling, a totally enclosed system removes the possibility of product contamination. On Cozzoli’s powder filler, fill volume of each piston can be independently adjusted during operation. Two to sixteen fill stations are available. Multiple dose fills are made possible by simply setting the microprocessor. Product loss due to dusting is virtually eliminated.

For vacuum powder filling, a totally enclosed system removes the possibility of product contamination. On Cozzoli’s powder filler, fill volume of each piston can be independently adjusted during operation. Two to sixteen fill stations are available. Multiple dose fills are made possible by simply setting the microprocessor. Product loss due to dusting is virtually eliminated.

 

For vacuum powder filling, a totally enclosed system removes the possibility of product contamination. On Cozzoli’s powder filler, fill volume of each piston can be independently adjusted during operation. Two to sixteen fill stations are available. Multiple dose fills are made possible by simply setting the microprocessor. Product loss due to dusting is virtually eliminated.

 

 

 

Cozzoli Machine Company manufactures a complete line of liquid and powder filling equipment. For more information, please visit www.cozzoli.com.

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Film Coating

Film coating represents an important process step in the pharmaceutical industry. The majority of coating processes are performed for drug release modification, drug stability improvement against light or moisture and taste masking.

The coating process consists of simultaneous spraying, mixing and drying processes. A good coating uniformity can only be achieved with the choice of the proper parameters. To meet these requirements state of the art coating technology contains unique design principles:

  • Unique helical baffles consist of two layers of baffles. They are responsible for the continuous and homogeneous axial mixing within the tablet bed. In addition the drum rotation is maintaining the radial mixing. Both movements guarantee a dead zone free tablet bed.
    Tablets will not be damage or even twinning.
  • Pan geometry with an L/D ratio >1 offers a large tablet bed surface, which enlarges the incorporation of more spray guns. So, process time can be saved up to 40% due to larger throughput of coating suspension.
  • The air principle utilizes the drying capacity where it is most needed: in the tablet bed! Thus most effectively the drying capacity of the inlet air is used without heating the rest of the coater inner parts.
    Baffle and Air Flow DesignPan geometry
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Electronic Data Security with Pharmaceutical Grade Washers and Sterilizers

Olivier Van Houtte
Product Manager, Life Sciences Washing Systems

Managing electronic data, complying with evolving regulatory requirements and reducing paper records can be a daunting task for pharmaceutical manufacturers. It is now possible to easily manage critical electronic data related to production batches, equipment status and user actions. New technologies allow for transferring electronic data to a centralized SCADA system or developing stand-alone Electronic Data Management platforms. Solutions have been developed, tested and documented in accordance with GAMP 5 guidelines and provide the capability for complying with FDA (21 CFR Part 11) and European (Annex 11) regulations. The packages allow users to configure a comprehensive, yet cost effective system to manage vital electronic data using; Audit Trail, Password Security, E-Signatures, Data Archiving and Batch Data reporting.

Electronic Data Security Base Package (Figure 1)

Configured for users who have their own centralized data archiving and reporting capability.

The system includes:

  • Audit trail includes user identification, time and date for initiation of cycle, cycle abort, cycle parameter changes, alarm acknowledgments, unsuccessful login login/access attempts, etc. Audit trail is viewable from the HMI.
  • Local memory card for temporary data storage of audit trail and batch cycle data
  • Ethernet port: Batch data and audit trail can be exported to a customer supplied control system in a transportable format. Audit trail is transferred in CSV format. Data registers can also be read from the PLC via Ethernet
  • Password Protection: password protection features including unique access levels, aging, alpha numeric requirements, automatic log-out, etc.
  • E-signature: E-signature for final batch verification/acceptance is available

Electronic Data Security Base PackageElectronic Data Security Base Package

Figure 1 – Electronic Data Security Base Package

Electronic Data Security with Data Archiving and Enhanced Batch Reporting (Figure 2)

The system includes:

  • Audit trail includes user identification, time and date for initiation of cycle, cycle abort, cycle parameter changes, alarm acknowledgments, unsuccessful login login/access attempts, etc. Audit trail is viewable from the PC.
  • Local hard drive for storage of audit trail and batch cycle data
  • Batch reporting: predefined batch report in PDF format, batch report may be exported or printed using remote printer
  • Ethernet port: Batch data and audit trail can be exported to a customer supplied control system in CSV format. Batch data can be exported in PDF format. Data registers can also be read from the PLC via Ethernet
  • Password Protection: password protection features including unique access levels, aging, alpha numeric requirements, automatic log-out, etc.
  • E-signature: E-signature for final batch verification/acceptance is available

Electronic Data Security with Data Archiving and Enhanced Batch Reporting

Figure 2 – Electronic Data Security with Data Archiving and Enhanced Batch Reporting

These packages can help achieve faster process validation, more efficient operations, greater cost control and more importantly, comply with industry regulations for Electronic Data Security.

To learn more about pharmaceutical grade washers and sterilizers that are compatible with these solutions, please click:

http://www.sterislifesciences.com/Products/Equipment/Washing.aspx

http://www.sterislifesciences.com/Products/Equipment/Sterilization/GMP-Steam-Sterilizers.aspx


INTERPHEX

Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.

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Modularization Process in Project Delivery (Part 2)

By: Gene Martini, Design Vice President – IPS

You’ve decided that you want to modularize elements of your new facility. The benefits –better cost control, reduced schedule, and transfer of risk away from your jobsite — are too great to ignore. So how should you go about it? What changes do you make to your engineering, procurement, construction, and compliance processes to maximize the benefits of modularization?

In the past, modularization efforts were undertaken after the design process was complete, using construction documents as input information. This approach yielded some benefits, but it generally optimized the construction process given the specific constraints of the design as depicted in the construction documents. This process evolved as the need to benefit from modularization increased and constructors became more knowledgeable and aggressive in pursuit of efficiency. Eventually, constructors began modifying designs to maximize modularization, and owners accepted this approach because of the significant benefits.

Not to be outdone by their construction industry brethren, designers have modified their processes to include a modularization step early in the project life cycle. Today, most designers develop a concept for a new facility, and immediately study the modularization options for the project to ensure that subsequent design phases accommodate modularization objectives. The process that is typically employed today is depicted in the following diagram.

image02.03

This process is iterative; the function of the facility is defined in a conceptual design study, then modularization options are generated, the impact of those options on cost, schedule, and quality are is evaluated, and the facility design is adjusted to take advantage of the selected modularization decisions. This approach can achieve much of the desired benefit of modularization, but it has some obvious flaws. Can the iterations be eliminated? Can modularization be built into the conceptual design?


INTERPHEX

Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.

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Modularization Process in Project Delivery (Part 1)

By: Gene Martini, Design Vice President – IPS

Modularization has been explored and exploited in the delivery of pharmaceutical facilities for many years; the concept can now be considered mature. The objectives are unchanged: reduced time from decision to delivery, reduced risk of cost escalation, and transfer of risky construction activities away from the field and into the fabrication shop where safety and quality can be better controlled.

The solutions have been tried and tested too; process systems have been modularized as “skids.” Sheetrock wall construction once requiring numerous steps, widely varying skills, controlled conditions, and two weeks of work just to complete a single room has yielded to modular wall panel installation that requires a single craft and a quarter of the time in the field. Stick-built pipe racks, chiller buildings, and air handling systems have been replaced by drop-in modules. And structural modularizations have diverged into a wide range of solutions such as box-in-box designs and portable shipping container laboratories.

The most recent development in modularization is the implementation of design, construction, and commissioning processes that result in optimal modularization decisions at the optimal points in the project life cycle.


INTERPHEX

Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.

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Developing Flexibility and Efficiency in Biomanufacturing Facilities

By Jeff Odum, IPS-Integrated Project Services

Manufacturing Life CycleCurrent developments in the biopharmaceutical industry have added significantly to the challenges of designing, building, and operating biopharmaceutical manufacturing facilities.  With increasing insights into product requirements and product characterization, the critical path for the development of new products is shifting to process development and manufacturing timelines where speed and flexibility are now more critical than ever.  Future manufacturing systems must be agile enough to deliver more types of products in a shorter time frame.

The traditional business model of highly integrated facilities does not allow for this needed increase in operational effectiveness.  A new business model is emerging that focuses on flexibility, operability, and utilization where companies can adapt rapidly to changing market conditions.

Manufacturing simultaneous, short multi-product campaigns to supply clinical material, run conformance lots, build initial inventory, and supply commercial material only adds to the complexity of running a biopharmaceutical manufacturing enterprise.

The new generation options of facility design involve the implementation of single-use technologies and new platform technologies along with a flexible approach to facility integration. With QbD as a significant foundation of facility design, these facilities will be “designed to operate” in order to provide a higher level of flexibility, utilization, and operational excellence.Developing Flexibility and Efficiency in Biomanufacturing Facilities

These facilities implement modular delivery approaches that include rapid deployment options, interchangeability of suites, and smaller footprints that respond to the demands of the new business model of the industry.  The ability to move processes in and out of the facility quickly and efficiently can greatly increase the throughput of the facility and permit flexibility in responding Developing Flexibility and Efficiency in Biomanufacturing Facilitiesto changing manufacturing requirements or deal with process problems. Capacity can be significantly increased by cloning the process equipment and installing additional production trains in available spaces.

At Interphex 2015, IPS will focus on these new technologies and approaches that support this new generation of biomanufacturing assets.


INTERPHEX

Learn more about the single source for complete biopharmaceutical manufacturing solutions that gathers 12,000 industry professionals each year.

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