News Article | October 29, 2016
HOLLOWAY AMERICA, a custom fabrication company specializing in pressure vessel design and tank repair, will attend the International Society of Pharmaceutical Engineers (ISPE) Boston Area Chapter’s 25th Annual Product Show Oct. 5th at Gillette Stadium in Foxborough, Ma. With over 8,000 in attendance, the ISPE Boston chapter’s flagship show is the largest one-day product show of its kind in the country. HOLLOWAY representatives will be available at space E9 to answer questions about the company’s popular stainless steel fittings, bioreactor vessels and biopharm process equipment, stainless steel atmospheric tanks and repair services. “The Boston ISPE show is one of the biggest of the year,” said HOLLOWAY Director of Engineering Evelyn Gayer. “Our team is looking forward to talking with attendees about ways we can safely, effectively streamline their production processes.” She noted that attendees typically want to discuss everything from pressure vessel repairs to replacing original pressure vessel components to the company’s custom vessel design and fabrication services. “We love to talk shop with people involved with ISPE, so we’re excited to answer any questions and discover new ways HOLLOWAY can help our peers,” added Gayer. The ISPE Boston Chapter Product Show boasts a day full of engaging sessions and keynotes, hundreds of industry leaders in a large exhibit hall, an innovation stage, one of the largest job fairs and networking events in the area, a charity drive and a famous after-party. Conference organizers have also scheduled some extra fun into the event. A stop by the Champions for Charity pavilion in the West Clubhouse will give attendees an opportunity to meet New England Patriots alumni Scott Zolak, Jermaine Wiggins and Ronnie Lippett, along with current Patriots cheerleaders. The after-party at Splitsville/Howl At The Moon is located at Patriot Place and features pristine bowling alleys and dueling pianos. Guests can also get autographs and pictures with Patriots Defensive End Rob Ninkovich. The ISPE Boston Chapter Product Show will be packed full of activity from 8 a.m. to 9:30 p.m. on Wednesday, Oct. 5. Coffee and breakfast will be served in the morning, and education classes, exhibit halls and career fairs will be open throughout the day. The schedule of events for the day is as follows: Those interested in attending the product show can register online at ispeboston(dot)org. For details about HOLLOWAY AMERICA’s pressure vessels, repair services or original pressure vessel components, contact a representative at 417.863.0077 or by email at info(at)HollowayAmerica(dot)com.
News Article | November 9, 2016
GLENCOE, MO, November 09, 2016-- Dr. Sudhirkumar Brahmbhatt has been included in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.A chemicals executive with more than three decades of experience, Dr. Brahmbhatt has made a tremendous impact on a variety of industries such as Biotech and Pharma, Environmental, Chemical, Metal, Food, High pressure cylinder and more with regard to optimization and efficiency improvements in processes and technologies. He holds many patents such as Oxygen assisted Fermentation for Biotech, Optimize process variables in oxygen enriched fermentors, tech in bio-diesel, lyophilization with Liquid N2, Multipurpose, spark free and antibacterial wrench for cylinders, Method for sterilization of medical devices, Apparatus for injecting cryogenic liquid into containers for drink industry, Use of nitrogen to thaw plates in LIN based lyophilization, System and method for oxygenating waste water, System and method for refining sugar, Regeneration of adsorption bed using heated nitrogen, Freezing biological products, System and method for operating a pulp mill, Non cryogenic method and apparatus for producing pure nitrogen, Process and apparatus for recovering sterilizing gases, Method and apparatus for producing Spheroidal glass particles, High Temperature burner - AFP burner for metal industry, system for producing a regulated atmosphere for a high temperature process. And more. Additionally, in recognition of professional excellence, he was named Top Performer by the Applied Technology Group of MG Industries on six occasions. He was also the winner of an Innovation Award and a Best ATG Sales Support Award from Messer GmbH. Dr. Brahmbhatt is proud to have been selected for inclusion in Who's Who in Finance and Business, Who's Who in America, Who's Who in Science and Engineering, Who's Who in the Midwest, and Who's Who in the World. He has written papers in reputed magazines such as Chemical Engineering, Ceramic Bulletin, and Cryogas International (now GasWorld Magazine). He also has presented papers at conferences such as AIChE, Ceramic Expo tec.Over the course of his career, Dr. Brahmbhatt served as the head of the research and development department of MG Industries, where he held many additional roles during his time there. He was manager of the chemical group, team leader of global pulp and paper technology, director of technology, senior group manager, applications engineer, senior project engineer and manager of the chemicals group. Dr. Brahmbhatt also held prominent roles with Air Liquide, including group manager, manager of special projects, and technology manager for biotech and pharmaceuticals. Additional chemical engineering projects that Dr. Brahmbhatt has spearheaded include those with Exxon Co., Air Products and Chemicals, Inc., and Ashutej Co., a company that he founded. Today, Dr. Brahmbhatt is the president and owner of Technology Services, Inc. ( www.tsinc-us.com ).Dr. Brahmbhatt prepared for his career by achieving a Bachelor of Engineering specializing in chemical engineering and a Master of Engineering with specialization in chemical engineering from Nadiad Institute of Technology and the Steven Institute of Technology, respectively. He also earned a degree in polymer science at Stevens Institute of Tech. Thereafter, he obtained an MBA in international management and marketing from Fairleigh Dickinson University, and a Ph.D. in chemical engineering from Kennedy Western University. He also directed and hosted a radio program for 25 years and has a license in broadcasting from the Federal Communications Commission. As a volunteer leader, he has founded and continues managing a unique and most successful voluntary non profit organization called 'Center for Indian Cultural education- Bal Vihar of St. Louis'. This unique organization instills diversity and Asia Indian culture in children ages 5 through 16 regardless of their religion and has been thriving over the last 25 years in St. Louis, MO. The school has graduated over 1000 students over the years and continues its mission and vision with enrollment of 450 students in his weekend school. His voluntary staff includes 70+ teachers and a 30 + admin team to ensure that organization goals are met professionally ( www.balvihaar-stlouis.com ).Dr. Brahmbhatt stays at the top of his field through his affiliations with technical associations such as the Pulp and Paper Industry, the American Institute of Chemical Engineers, the ISPE, the American Society of Metals, the American Ceramic Society, the American Chemical Society and the American Powder Metallurgy Institute.He continues his contribution in the manufacturing industries by developing new processes whether by applied technology or fundamental research specifically in Biotech area or Environment area. Looking forward, he intends to continue excelling in the field of chemical engineering.About Marquis Who's Who :Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America , Marquis Who's Who has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Today, Who's Who in America remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. Marquis now publishes many Who's Who titles, including Who's Who in America , Who's Who in the World , Who's Who in American Law , Who's Who in Medicine and Healthcare , Who's Who in Science and Engineering , and Who's Who in Asia . Marquis publications may be visited at the official Marquis Who's Who website at www.marquiswhoswho.com
News Article | November 1, 2016
HOLLOWAY AMERICA, a stainless steel pressure vessel fabrication company, announced today it will host a booth at Pharma EXPO and PACK EXPO International 2016 from Nov. 6-9 at McCormick Place in Chicago. The annual event is a joint venture hosted by the International Society for Pharmaceutical Engineering (ISPE) and the Packaging Machinery Manufacturers Institute (PMMI). Representatives from HOLLOWAY will join more than 50,000 professionals from various industries at the largest conference center in North America. At booth W-1033, HOLLOWAY AMERICA will be on hand to share information about its ASME pressure vessels, including pharmaceutical-grade mixing tanks and vessels, fabricated for high pressure or atmospheric conditions. Company representatives will be available to discuss planning and estimating requirements for custom-fabricated mixers, bioreactors or fermenters that meet one-of-kind specs, depending on the client’s needs. “We’re always happy to answer questions about our stainless steel fermenters, mixing tanks and other pressure vessels as well as discuss HOLLOWAY’s VesselWellness™ Program,” said Director of Marketing Randy Colwell. The company’s popular preventative maintenance program Colwell referenced involves meticulous pressure vessel inspection procedures designed to ensure equipment adheres to or exceeds standards for the pharmaceutical, biopharm and packaging industries. “That said,” Colwell added, “regulations vary from country to country, so at an international conference like this, we often field questions about our ability to engineer and fabricate code-ready vessels for our diverse clientele.” The exhibition, which started as a packaging show, eventually evolved into a joint effort with the ISPE and the PMMI as conference organizers discovered a significant interest among professionals from both packaging and pharmaceutical processing companies. Today, the co-located Pharma EXPO and PACK EXPO bring together more pharmaceutical professionals, manufacturers and suppliers than any other conference in the world, as stated on the event website. In addition to HOLLOWAY’s custom-fabricated equipment, attendees will have the opportunity to learn about thousands of other technological breakthroughs at the expo. Conference attendees can explore the leading solutions in processing and packaging equipment, learn about the latest breakthroughs at the Innovation Stage, attend free educational courses and network with thousands of peers. Conference highlights include a First Timers’ Lounge, industry-themed innovation pavilions and a charity event featuring magician-comic duo Penn & Teller. For more information about HOLLOWAY AMERICA’s stainless steel ASME pressure vessels, components and services, contact a representative at 417.863.0077 or by email at info(at)HollowayAmerica(dot)com. For additional details on Pharma EXPO and PACK EXPO, visit pharmaexpo(dot)com and packexpointernational(dot)com.
News Article | October 28, 2016
Superior Controls, Inc., a leading control system integrator of custom industrial automation and IT solutions, today announced it will attend both the Product Show and Career Fair for the International Society of Pharmaceutical Engineering (ISPE) at Gillette Stadium in Foxborough, MA on October 5, 2016. Superior Controls’ President Rick Pierro has been an active member of ISPE’s Boston chapter, previously serving as president, vice-president, chairman of student affairs and long-time board member of the organization. Pierro is still active within several of the organization’s committees, and was instrumental in the 2006 change of venue when ISPE moved the annual show to its current location at Gillette Stadium. “We are excited to participate in the ISPE Product Show for our 20th consecutive year,” said Pierro. “ISPE is an organization that Superior Controls is heavily involved with, and we look forward to another great event this year at Gillette Stadium. We hope to meet many qualified candidates for job openings in our Seabrook, NH and Albany, NY offices.” Superior Controls will bring more than 20 engineers to the ISPE event, staffing booths in both the Product Show (table W11) and the Career Fair (table C35). The company employs 70 plus degreed experienced automation engineers, including 3 with PhDs and 9 with Masters degrees. Known as an expert in automation for highly regulated biotech companies, Superior Controls is currently experiencing rapid growth. The company has hired more than 20 engineers so far this year for both its Seabrook, NH headquarters and new facility in Albany, NY. Superior Controls aims to further expand its workforce by adding experienced and degreed automation engineers. The company hires talented engineers who are knowledgeable in Allen-Bradley, GE, Delta V and/or Siemens controllers; iFIX, FactoryTalk View, and/or Wonderware SCADA software; and/or who are skilled in Visual Basic programming, SQL Server or other databases, and broad IT experience. To learn more about career opportunities, please contact us. To register to attend the ISPE Boston Area Chapter Product Show and Career Fair, click here. About Superior Controls, Inc. Since 1993, Superior Controls, Inc. has reliably delivered professionally executed automation and control systems integration services to leading companies in 30 separate states and 15 countries. In addition to being six-time certified by the Control System Integrators Association (CSIA), Superior Controls has passed a number of project management and validation audits performed by industry leaders such as Pfizer, Biogen, GE Healthcare, and more. As Superior Controls now undergoes expansion, it will exhibit the same commitment to innovation and quality that customers have come to expect over the last 23 years. To learn more, visit http://www.SuperiorControls.com
News Article | February 15, 2017
The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards (FOYA) program today announced its 2017 Category Award winners: FOYA’s judging panel has also awarded Honorable Mentions to: This premier global awards program recognizes innovation and creativity in manufacturing facilities serving the regulated healthcare industry. Projects selected for the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations. “We are proud to honor these eight organizations that share ISPE’s commitment to innovate and advance pharmaceutical manufacturing technology for the benefit of all global patients,” said John Bournas, ISPE CEO and President. 2017 Facility of the Year Category Award Winners Abbott is the winner of the Operational Excellence category for success of its “Operational Excellence – A New Quality Approach" project initiated at the Abbott Diagnostics facility in Longford, Ireland. The site has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality--while also reducing cost per unit, cycle times, equipment down-time, and inventory holdings. Bristol-Myers Squibb won the Facility Integration category for its Biologics Development Building and the Clinical Manufacturing Building project located in Devens, Massachusetts, USA. These facilities were recognized as outstanding examples of how to integrate new capabilities within an existing plant through careful design, good collaboration, as well as creative engineering. Cook Pharmica is the winner of the Equipment Innovation category for its Flexible Filling Line project in Bloomington, Indiana, USA. This collaborative development between owner, suppliers, and engineering experts delivered a novel application of commercially available and custom developed equipment innovation manufacturing solutions that drove superior commercial market changing technology and supply chain flexibility in a unique “ready-to-use” vial platform. Eli Lilly and Company has been awarded winner of the Process Innovation category for its Continuous Direct Compression Manufacturing Kits 2 & 3 project located in Indianapolis, Indiana, USA and Carolina, Puerto Rico. Their forward thinking approach brought on the implementation of Continuous Direct Compression (CDC) Process and other process innovations in their oral solid dose (OSD) facilities across their manufacturing network. Eli Lilly and Company has also been named winner of the Facility of the Future category for its process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Fundamental to the success of the project was the development of the progressive mass balance control scheme anchored by advanced automation and PAT technology— key to insuring consistent control, low process variability, and high quality assurance. Jazz Pharmaceuticals Ireland Limited is the winner of the Project Execution category for its creation of a greenfield manufacturing facility in Athlone, Ireland. Having no prior experience internally on building or operating a manufacturing facility, the Jazz “Project Rock” approach was highly pragmatic, and a model for lean project execution and integration of the investment from “project” phase to licensed GMP operations. Nephron Pharmaceuticals Corporation received an Honorable Mention for its facility in West Columbia, South Carolina, USA. The Nephron SC project was recognized for its use and integration of a suite of industry leading technologies such as laser guided vehicles, automated warehousing, robotics to eliminate human intervention, and track and trace technology. Novartis-Penn Center for Advanced Cellular Therapies received an Honorable Mention for its Center for Advanced Cellular Therapies (CACT) project in Philadelphia, Pennsylvania, USA. The facility leverages pharmaceutical engineering principles to successfully merge academic, corporate, and medical considerations thereby creating an innovative center to advance personalized medicine. PT. Kalbio Global Medika received an Honorable Mention for its greenfield Biotech Facility project in Jakarta, Indonesia. Kalbio’s young and highly motivated project team is an outstanding example of the “can do spirit”. It is a fine demonstration of the talent and potential for biomanufacturing in the region. The 2017 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet on 6 June 2017, in Arlington, Virginia, USA. The banquet, held in conjunction with the ISPE/FDA/PQRI Quality Manufacturing Conference, will feature presentations from the FOYA judging panel and other noted industry leaders. The 2017 FOYA Overall Winner will be announced at the 2017 ISPE Annual Meeting & Expo from 29 October – 1 November in San Diego, California, USA. Winners will also have the opportunity to make presentations during educational sessions at the ISPE Annual Meeting. About the ISPE Facility of the Year Awards Program Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit http://www.FacilityOfTheYear.org for more information. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.
News Article | February 27, 2017
The International Society for Pharmaceutical Engineering (ISPE) announced its inaugural Conference on Quality Culture and Quality Metrics, taking place 25 – 26 April in Bethesda, Maryland USA. This uniquely focused event will feature high-level sessions, aligned with the FDA’s revised draft guidance on quality metrics and ISPE’s on-going Quality Culture and Quality Metrics Initiatives. In-depth workshops will provide insights on the Six Dimensions Framework in the Cultural Excellence report. “Sustainable production of high quality, available products demand a knowledgeable and devoted mindset to improve quality culture,” said John Bournas, ISPE CEO and President. “This conference was crafted to provide an enriched understanding of how quality metrics and quality culture are used throughout the pharmaceutical industry to monitor quality management systems and processes, and drive continuous improvement efforts in drug manufacturing.” The ISPE Conference on Quality Culture and Quality Metrics will feature a collection of practical, powerful tools and a comprehensive, behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes. This event will also deliver the latest data and insights for operationalization of quality metrics across the supply chain. There will also be a high-level industry panel on quality culture, and special sessions on quality metrics with industry leaders and three FDA experts. To learn more about this event, visit http://www.ISPE.org/2017-Quality-Culture-Quality-Metrics-Conference. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.
News Article | October 28, 2016
Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced the appointment of Kunal Jaiswal to the role of Vice President, Strategic Development Solutions, Clinical Supply Services. In his role, Mr. Jaiswal will lead the company’s ongoing efforts to anticipate and act upon industry trends and technologies that may impact study sponsors, clinical sites, and patients, and to inform the development and delivery of current and future clinical supply services. Mr. Jaiswal brings over ten years of clinical supply chain operations experience. Most recently he was Director of Clinical Supply Packaging Operations at Pfizer with a prior engagement at Merck as Head of Supply Chain Strategy. Mr. Jaiswal is a recognized industry expert and former Chair of the ISPE’s (International Society for Pharmaceutical Engineering) Investigational Products Steering Committee. He holds a Bachelor’s degree in pharmacy from Purdue University and a Master’s in business administration from Western Michigan University. “Kunal is an important addition to our leadership team that will accelerate our ongoing efforts to develop and deliver industry-leading clinical supply solutions to our customers,” stated Wetteny Joseph, President of Catalent Clinical Supply Services. “His extensive experience brings our team a wealth of knowledge and unique customer perspective that will enable the next generation of clinical trial innovation in our industry.” About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,200 people, including over 1,400 scientists, more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
News Article | February 3, 2016
High containment gloveboxes (HCG) have been used in the pharmaceutical industry for containment of potent compounds, along with providing specific environmental conditions, for years. These types of glovebox design fit well into the Class III Bio Safety Cabinet classifications but provide even better environmental attributes than the standard BSC designs. Once you have decided on the best system and design, testing needs to completed. Testing methods are standard and can be applied to the HCGs. Testing of the HCGs would conform to the industry standard and include the following: 1. Testing should only be done by a third party. 2. Testing needs to be relevant to the biohazardous substance. 3. Testing of the HEPA filters by DOP with particle analysis a ROYCO counter. 5. Bacterial or BI are placed in the glovebox and a decontamination cycle is run and submitted for results. 6. Air changes per hour need to be verified. 1. Third party containment testing can be completed using the ISPE Guidelines. 2. Riboflavin testing for verification of CIP (clean in place systems). Testing should be robust and conform to industry standards for both types of systems. This cleanroom tip was taken from “ Cross Over from Class III BSC to High Containment Gloveboxes ” by Michelle Frisch. The article originally appeared in the issue of Controlled Environments.
News Article | November 8, 2016
G-CON today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for its Patent Application 12/856,888 entitled Modular, Self-Contained, Mobile Clean Room. G-CON was founded on this proprietary platform approach that transforms the way that cleanrooms are designed and built. G-CON’s in-house engineering team designs the PODs to meet the customer’s specifications followed by the PODs being built and qualified entirely in G-CON’s facilities. G-CON was the first to invent and offer this novel turnkey approach of delivering prefabricated cleanrooms, which are generally built in place and are provided as construction projects with attendant delays and unpredictable costs. The G-CON POD approach allows for a much more predictable result in terms of costs, schedule and quality since the same team builds each POD with the same core materials thereby avoiding product variability due to changing raw materials and transient construction crews. The U.S. Patent and Trademark’s Notice of Allowance validates the G-CON platform as a novel way to produce cleanrooms. Such a finding is the latest endorsement of the cleanroom POD approach with G-CON having won several awards for product innovation in the pharmaceutical and biopharmaceutical industry including but not limited to: The ISPE’s Faciltiy of the Year Award for Equipment Innovation 2016, Interphex’s Best Technology Innovation 2015, Pharmaceutical Processing’s Facility of the Year, and a Finalist in the category for Best Collaboration Partnerships for the 2016 BioProcess International Awards. Maik Jornitz, President and CEO of G-CON Manufacturing stated: “We are delighted to receive the Notice of Allowance from the U.S. Patent and Trademark Office. Such a Notice further validates our innovative POD approach. It motivates us to develop other cleanroom platforms, as well as unique facility concepts with our partners. When we started in 2009 we had one product for one application. Our product portfolio now includes a much larger variety of standard PODs, which can be configured to the needs of our customers. The current POD range meets the requirements of a number of applications, including bioprocessing, oral solid dosage forms, predesigned filling and single-use technology unit operations and the strict containment needs for ADCs and cell therapies. This notice and ultimately the patent strengthens our position of being the most advanced and largest prefabricated cleanroom provider globally.” About G-CON Manufacturing G-CON Manufacturing designs, builds and installs prefabricated, autonomous cleanroom PODs®. G-CON’s cleanroom POD® portfolio provides a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. The POD® cleanroom units surpass traditional cleanroom structures by virtue of their scalability, mobility and the possibility of repurposing the PODs® once the production process reaches its lifecycle end. For more information, please visit the G-CON’s website at http://www.gconbio.com.
Southeasts Largest Annual Gathering of Life Science Professionals Carolina South Atlantic Chapter of the International Society for Pharmaceutical Engineering Holds 24th Annual Life Sciences Technology Conference at the Raleigh Convention Center, R
News Article | February 15, 2017
RALEIGH, N.C., Feb. 15, 2017 /PRNewswire/ -- The Carolina-South Atlantic Chapter (CaSA) of the International Society for Pharmaceutical Engineering (ISPE) will host more than 1,000 life science professionals from major pharmaceutical companies in the southeast and beyond at the 24th...