Press Room

Hovione New Jersey welcomes a Team from OPQ of the FDA as part of the Experiential Learning Site Visit Program for a Training on Continuous Manufacturing. The main objective was to understand the technology and the science behind it, how does industry apply it and which challenges industry faces. The main purpose was to provide the FDA team a better understanding of drug development and manufacturing processes with continuous manufacturing.      

News
Hovione New Jersey welcomes a Team from the FDA for a Training on Continuous Manufacturing

FDA OPQ Training at Hovione New Jersey Site

Sep 18, 2018

In general, how has the efficiency and productivity of pharmaceuticals increased/evolved over the last 20 years and how much of this evolution is due the knowledge and experience contract development and manufacturing companies bring to the industry? The technological evolution in manufacturing of pharmaceuticals has not evolved as rapidly as in other industries. Therefore, gains in efficiency and productivity have improved less than in those industries which needed to change. Contract and development and manufacturing companies have brought a higher productivity and more efficiency to the pharmaceutical industry through higher and better utilization of assets and leveraging the knowledge and experience gathered by working in many different products. These companies contributed significantly to the industry during the last 20 years as their business model focused intensely on increasing productivity and efficiency. Over this same time period what has been Hovione’s mission? How has the company helped the pharmaceutical industry bring safe and effective treatments to market over the last 20 years? Hovione’s mission was the contract development and manufacturing company that not only provides the benefits of an organization focused on development and manufacturing mentioned above but mostly an organization that brings innovation to the industry helping solve most complicated issues in development and manufacturing of medicines. For example, Hovione started many years ago devoting a significant effort in the understanding of particle engineering, how this could solve formulation challenges and what technologies could enable those engineered particles. Focusing on the inhalation and oral formulation of poorly soluble drugs through amorphous solid dispersions Hovione developed a wealth of knowledge and capabilities that have helped numerous companies developing new medicines that today help millions of patients worldwide that otherwise would not have been possible. Hovione today leads the development and manufacturing of amorphous solid dispersions by spray drying and has developed a wide range of new technologies like spray congealing and a combination of technologies that control particle size distribution, morphology, provide taste masking and controlled release properties that are of paramount importance for today’s pharmaceutical development and manufacturing. Specifically, what services and expertise does Hovione currently offer to assist pharmaceutical clients to bring new drugs to market? Can you talk about your Integrated Science offering, capacity expansion, and your continuous manufacturing technologies? Hovione constantly seeks new technologies, develops scientific knowledge and sees how we evolve our organization to solve issues for the pharmaceutical industry. Hovione today offers a comprehensive range of services from API to final drug product that include process development, clinical batch and commercial manufacturing involving experts in chemistry, process engineering, analytical sciences, particle engineering and formulation scientists. The development of a new medicine involves a wide range of expertise and technologies that Hovione has brought together ultimately (spray drying, microfluidization, spray congealing, co-precipitation) to provide better drugs and faster development so patients in need can have access to life changing medicines quicker. Hovione offers an integrated approach from API to drug product as mentioned above. This integration not only speeds up product development but also allows our organization, scientists and engineers to share product/process knowledge. Our strategy has been also to develop this integrated approach at the same location to facilitate all the complex process associated with developing a drug and outsourcing.  Therefore, Hovione started an investment program to add capacity at multiple locations (Europe and US) in API, spray drying and drug product formulation namely in tableting. Hovione believes that continuous manufacturing (in chemistry and drug product) brings a new way of developing and manufacturing medicines adding more quality and flexibility into the manufacture of medicines while allowing a faster development path by reducing the effort necessary in scaling up processes. Hovione has embraced these technologies and has invested in continuous tableting because we believe that this will be a transformational technology to the industry. Looking ahead, are there any drug development and manufacturing technologies being developed now that will help pharma companies bring innovative products to the market? How will Hovione meet this challenge for its current and future clients? Continuous processing is still a relatively new technology in the pharmaceutical industry. Its adoption will certainly help pharma companies to bring innovative products to the market faster. Hovione is very much interested in providing this option to pharma companies and having a contract manufacturing organization capable of providing this solution is of paramount importance for biotech companies and for the overall drug development industry. There are other technologies being developed to address the challenge of poorly soluble drugs and other particle engineering manipulation solutions that Hovione is evaluating with the goal to bring these technologies to market to provide companies with options and better results. Being an innovative company with a strong pool of scientists Hovione is very well prepared to take some of these technologies into an industrial reality and providing a real solution to develop innovative products.   Read the article at APR's website.    

Article
American Pharmaceutical Review, September 2018

An Interview with Marco Gil, PhD

Sep 01, 2018

Hovione has earned a place on the 2018 Best for the World list by scoring in the top 10 percent among all B Corps on the B Impact Assessment. Best for the World lists are segmented by: Best Overall Best for Workers Best for Communities Best for the Environment Best for Customers Best for Governance This year Hovione is on the CUSTOMERS Best For The World list. Described by B Lab as "Improving Customers’ Lives and Opportunities Through Business". What is Best for the World?  Every year, B Lab highlights the Certified B Corporations with B Impact Assessment scores in the top 10% of the entire global community. Separate lists honor companies with the best overall scores as well as scores for each individual category in the BIA.    Find more about Hovione being a B Corp      

News
This year Hovione is on the CUSTOMERS Best For The World list.

Hovione is a Best For The World Company!

Jun 18, 2018

Rick Mullin interviews Frédéric Kahn at CPhI North America.         Hovione, which has likewise added services, including spray drying and finished-dose form manufacturing, in the past two years, continues to invest both at its headquarters in Loures, Portugal, and at its technology center in East Windsor, N.J. The company spent about $100 million in 2017 and plans to invest as much again this year and next, according to Vice President for Sales and Marketing Frédéric Kahn. Hovione opened a 7,000-m2 development services center at its main manufacturing facility in Loures, equipped to handle highly potent compounds. With 200 people hired over the past three years, the site now employs a staff of 1,600. Hovione may hire another 200, Kahn said. In New Jersey, the company is in the process of doubling chemistry and analytical service capacity and will begin operating a continuous tableting facility this month. Kahn says Hovione is interested in offering one-site shopping in Portugal and New Jersey. The plan over the next three years is to continue investment, especially in Portugal, Kahn said, where the firm will add 165 m3 of chemical synthesis capacity, a spray-dryer building, and a 1,200-m3 analytical lab. “This is capacity that we are going to have to sell,” Kahn acknowledged, “but we pursued it by listening to our customers—by understanding what their requirements are in terms of API, formulation, solubility enhancements, and continuous tableting.” Kahn declined to call the added services a push toward the one-stop-shop model. Rather, he said, the firm will now offer one-site, full-supply-chain service in both Portugal and New Jersey.   Read the entire article    

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C&EN, May 21, 2018

The good times keep rolling in pharmaceutical chemicals

May 29, 2018

Small gestures can truly change the world!   Ivan Villax, who was born on April, the 16th of 1925 in a small town in Hungary, left his country when he was 23 years old with a toothbrush in one pocket and a Chemical Engineering Diploma in the other. Later on, in 1959, already in Portugal, Ivan Villax, together with Diane Villax and two other Hungarians, founded Hovione. On April the 20th of 2018 we celebrated the second Ivan Villax Day across all Hovione sites (Portugal, Ireland, Macau and USA). Team-members across all sites went back to the community and ensured that they had a significant positive impact: Planted trees in Loures Did volunteering work with homeless in Cork Donated rice and oil in Macao Donated personal care items in New Jersey Loures In Loures, about 115 Team Members from the various sites and offices of Hovione participated in an action to replant 500 trees, pines and cork oaks on a municipal site. The planting of these trees will contribute to the reduction of the CO2 emissions to the atmosphere, thus reducing the effects of climate change caused by the accumulation of greenhouse gases. This initiative was supported and closely monitored by the field technicians of the Division of Green Zones and Forests of the Municipality of Loures. Cork In Cork around 120 Team Members volunteered at two homeless shelters, in which they painted and treated the gardens of the shelters. Furthermore, the result of a Cake Sale was also donated. This year, the focus was to work with a well recognised local and national agency, the Simon Community, to support the homeless people. Macau “Love Food Sharing" was a campaign organized by Hovione Macau with the cooperation of Centro do Serviço de Fornecimento Temporário de Alimentos da Caritas and its aim is to share food and love with the elderly. On this day, 31 Team Members in Macau visited 40 elderly families in need and gave them 80 bottles of cooking oil and rice sacks. New Jersey In New Jersey, over the course of a month, 110 people donated hundreds of personal care items for local community members in need. Additionally, Team Members attended an event where they put all the items together in care packages, which included inspirational words of encouragement and support to those struggling in the local community.

News
Team-members across all sites went back to the community and ensured that they had a significant positive impact

2018 Ivan Villax Day

Apr 20, 2018

        PH: How is business right now? Gil: Business is going well. The CDMO industry is quite busy, not just Hovione. It comes naturally from the good environment that investors found in the biotech sector overall, so there are many programmes ongoing in development. Business is well funded, there is a lot of activity and CDMOs benefit from that. Also, large pharma continues to divest manufacturing assets. The trends of recent years remain and I think they will continue for the next months. The off-patents business is growing too. There is a lot of interest in niche, specialised APIs with specific properties from a physical standpoint. PH: What specialised technologies are you investing in? Gil: Spray drying is one of our core technologies,...   Read the full interview

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TKS, TeckoScienze Publisher, March 22, 2018

Five Minutes with Marco Gil - DCAT WEEK’18

Mar 22, 2018

Loures, Portugal, March 19, 2018 – Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey, with the aim to: increase capacity in existing technologies, like spray drying and grow in new areas of business to support its clients demand. The capacity expansion program started in 2016 and will continue in the coming five years. In the first two years, Hovione has relocated its development services to a new centre with 7.000 m2 in Lisbon, fifteen minutes away from the Loures manufacturing site, fully equipped with the most recent tools where Hovione is able to handle potent and highly potent compounds. The new building hosts 200 scientists from the chemistry, particle engineering, formulation and analytical development areas. In this period, Loures site expanded its drug substance reaction vessel capacity with a small scale production area and a new pilot plant, totalling additional 30 m3 of capacity. In addition, one pilot and two large scale spray dryers were installed at the site and started the operation of a new drug product centre equipped with oral dosage form and inhalation manufacturing capabilities. During the same time, Hovione doubled the size of its development and manufacturing operations in the New Jersey site, providing it with a full range of capabilities, from chemical & analytical development, through spray drying to formulation. The site now hosts 14 m3 of reaction vessel capacity with four independent trains, a pilot and a large scale spray dryer and a continuous tableting unit. In the Cork site, Hovione is reinstating and renewing a production building with 157m3 of chemical synthesis capacity devoted to contract manufacturing.  About half of this capacity will be ready for operation by May 2018. Over the next three years Hovione will add to the Loures site a new chemical synthesis and spray dryer building for contract manufacturing, with a total area of 4,200 m2 for 165m3 of reaction vessel capacity and two large spray drying units, new formulation facilities that will enable the production of bigger batch sizes and a new building that will host additional 1200 m2 of analytical laboratories. This investment effort is being paired with recruiting and training new staff clearly illustrated by a 39% headcount growth in the last 2 years.  “This addition in capacity expansion will secure our growth and ensure that we continue to provide a truly integrated full-service solution to our customers, as well as showing Hovione’s strategy and commitment to further strengthen its global market leadership in Spray Drying” said Frédéric Kahn, Vice-President Marketing & Sales. “This capacity expansion plan is far more than a matter of production capacity solely. It aims to reorganize sites with new buildings, renew existing facilities and give operations the most advanced equipment in the market, to provide our customers and team members with the technology and the capacity they need to grow in a sustainable way. It is a significant effort and commitment from Hovione to stay ahead of and prepare for future demand.” said Nuno Almeida, Vice-President of Engineering.   About Hovione Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

Press Release
Hovione reported today recent capacity expansion and future plans in its sites in Portugal, Ireland and New Jersey.

Hovione reports on recent capacity expansion and future plans to support growth

Mar 19, 2018

Loures, Portugal, March 8, 2018 – Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities. The inspections revealed that all Hovione sites were in compliance, this reflects a solid Quality System and a vibrant Quality Culture. This is the first press release that reports on the outcomes of inspections in the previous year. This will now be a regular commitment, it is another feature of our commitment to transparency. Hovione inspections during 2017 Site Authority Date Type of inspection Outcome Portugal      Ministry of Healthcare of the Russian Federation   Jan 2017      PAI for an Intermediate Drug Product         GMP certificate granted   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Mar 2017 PAI for an Intermediate Drug Product Form 483 – 6 observations Site approved   Nov 2017 Surveillance inspection No Form 483 INFARMED, Portugal, EU   Jul 2017 GMP inspection to a new building GMP certificate granted Macau PMDA, Japan   Dec 2017 GMP inspection 11 minor observations reported Ireland Ministry of Healthcare of the Russian Federation   Jul 2017 PAI for an Intermediate Drug Product GMP certificate granted FDA, USA   Dec 2017 Surveillance inspection No Form 483 “Each inspection at Hovione is considered to be of highest importance for the organization and for our customers. We are considering every audit and every inspection as a learning opportunity to continuously improve our Quality Systems and Operative Mechanisms. The number of inspections and their outcome demonstrate our commitment and capacity in the development of new drugs, and ability to manufacture highest quality products for our customers as well as for millions of patients that we proudly serve together. We are especially happy to share that all of the GMP surveillance inspections were concluded successfully with no form 483 observation.” said Joerg Gampfer, Vice President of Quality at Hovione. “We have a culture of quality that puts patient safety first. These inspections are important steps for Hovione and our customers. They shape our behaviors and motivate us to always improve our services to customers. Hovione has all the ingredients for an outstanding partnership going from clinical programs all the way to commercial supply.” added Frédéric Kahn, Vice President Marketing and Sales.   About Hovione Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

Press Release
Hovione announced today that in the last year their manufacturing facilities were the object of eight inspections, performed by different Health Authorities.

Compliance at Hovione - Annual Inspection Review

Mar 08, 2018

Hong Kong, 7th of March 2018: Hovione announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited. For Hovione this sale marks the end of a 24 years history of reliable and uninterrupted supply of iopamidol and iohexol API to the generic industry globally. Hovione entered the generic contrast media business in 1993 and in 2007 moved most of its manufacture to the iMAX factory in China because its capacity in Europe was no longer able to meet clients’ demand. This business continued to show a steady profitable growth and for most of that period represented the largest tonnage of Hovione’s product portfolio. Over the course of these 20 years formulations containing Hovione’s contrast media have been supplied to the growing markets of Asia and have included Japan’s best selling generic medicine. Faced with considerable opportunities in both the contrast agents business and all its other segments, Hovione decided to focus on its CDMO business, on its off-patent business supplying highly specialized APIs and to exit the large volume business of contrast media. The very significant expansion plans that Hovione has embarked upon since 2016 require all of our attention. “Getting into iopamidol and iohexol was a decision we took in 1993. Today Hovione’s strategy focuses on difficult to make and difficult to formulate products, supplied to demanding markets, serving innovative clients. Our contrast media business is growing and has many loyal clients that demand high quality, but it increasingly does not seem a good fit with the rest of our activities. The opportunity to sell iMAX with its manufacturing business of APIs and formulated product to a market leader makes sure this business can continue to develop even better. We are convinced that the buyer will be good owner and employer, and will continue supplying reliably the great clients that have supported iMAX’s growth.” said Guy Villax, CEO.   About Hovione Hovione has over 57 years of experience as a CDMO and is currently a fully integrated supplier offering from drug substance to drug product intermediate to drug product. With four FDA inspected sites in the US, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services. 

Press Release
Hovione announces that it has concluded the sale of all of the share capital of iMAX Diagnostic Imaging limited.

Hovione sells the iMAX business

Mar 07, 2018

Smart companies are focusing on internal training schemes to develop and mentor graduate employees. The challenge of attracting the right people in a highly competitive recruitment market is leading many organisations to consider developing their own talent from within. While formal graduate programmes are nothing new in larger organisations, such schemes are becoming more common at smaller companies. Recruitment firm Fastnet, which has offices in Cork and Dublin, has been successful at developing its own talent rather than hiring from competitors over the past 15 or 20 years, according to managing partner Niamh O’Driscoll. She said a formal graduate programme that brings people into the company at a very early stage was the next logical step. The first two graduates- one with a psychology degree and the other with a biochemistry background- have been taken on for the two year rotational programme. After six months getting to grips with all aspects of Fastnet’s business, the new hires will work in the talent acquisition division, focused initially on quality and laboratory, and then on engineering. “We have a very specific methodology and core values”, said O’ Driscoll. “The programme allows us to instil our values from the beginning and will help ensure there is a consistent pipeline of quality talent coming up”. Portuguese pharmaceutical company Hovione, which has a contract manufacturing site in Cork that employs more than 200 people, has also been looking at innovative ways of developing talent. “We’re quite a small company so we’re not going to have a huge internal mentoring or graduate recruitment programme” said human resources director Mary Hennessy. “We’ve tried to align with international programmes where we can facilitate one or two graduates.” INOV Contacto, is an EU-funded scheme that enables young Portuguese’s workers to work abroad for six months as interns in multinational companies. In Hovione’s case, the candidates typically have a master’s degree or a PHD in chemistry. “At the end of the placement it’s up to us if we want to offer a full-time position” said Hennessy. “Both of the participants so far have stayed with us and relocated to Cork as process engineers”. The company also participates in the Ibec Global Graduates Programme, taking on two people through this route each year. The 12 month programme involves six months working with the Cork team and six months based in one of the other Hovione sites in Lisbon, New Jersey or Macau. The company has gone on to hire six graduates through this programme. Read Article  

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The Sunday Times, February 18, 2018

Invest in talent to find future leaders

Feb 18, 2018

"This is a big story," says Guy Villax, CEO of the Portuguese API manufacturer Hovione. "I think the impact is going to be widespread."   Companies assess the short-term chaos and long-term promise that the campaign will have on their supply chains. When Xi Jinping came to power in China in 2013, the ambitious new general secretary claimed he would usher in an era of stricter enforcement of pollution control. Along with his highly publicized agenda to root out corruption, Xi declared that Chinese industry would be brought into line with global standards of environmental performance, significantly reducing smog and water pollution in and near major cities. Not that China . . . Read the article    

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C&EN, February 12, 2018

Drug chemical makers brace as China cracks down on pollution

Feb 12, 2018

Hovione doctoral researcher Beatriz Noriega returns to ISAB’s labs in Stockholm for her ongoing research into preclinical in vitro dissolution testing. She talks to Lab Blog about why she believes dissolution testing is critical, and how she’s hoping to prove it.   Hovione Ph.D. researcher Beatriz Noriega has been working for two years so far on her doctoral thesis, authoring four well-received posters and with two accepted for the next Respiratory Drug Delivery (RDD) Conference in April 2018. This is Beatriz’s second research visit to ISAB’s labs to use the in vitro simulation tool DissolvIt, as part of her work in the Particle Design and Inhalation Development department of Hovione’s R&D Drug Product Development. Her mission? “No matter how similar formulations may seem, until you analyze dissolution you never really know,” says Beatriz. She took time out from her research to talk to our ISAB Lab Blog.     Read the entire interview at Inhalation.se    

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LAB BLOG: Inhalation Sciences, February 8, 2018

Hovione Researcher on month-long study visit to ISAB Labs

Feb 08, 2018

Loures, Portugal, January 24th, 2018 – Hovione announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities. This investment reinforces Hovione’s Services portfolio in inhalation product development capabilities, which include proprietary particle engineering technologies as well as formulation and capsule filling capacity to support from development to commercial scale projects. Hovione’s new MG2 Tekna Precision Capsule filling unit complements our offering in encapsulation for inhalation products and has capacity for up to 110,000 capsules per hour with 100% net weight check and is fit to process highly potent compounds (down to 30 ng/m3). This unit complements the MG2 Flexalab and Mettler-Toledo Quantos encapsulation units that allows capsule filling for Phase I and Phase II clinical trials. In parallel Hovione has installed capacity in particle engineering suitable for inhalation, namely a multiple scale Spray Drying units for highly potent compounds, as well as a new wet polishing suite, and strengthened its analytical characterization toolbox. From formulation composition, optimization and precision capsule filling with 100% fill weight check, to analytical characterization and scale-up to a commercial scale, Hovione can take product from the early proof of concept stages up to a fully developed and scaled process. Together with our API and particle engineering capabilities, we can fully develop and produce any Inhalation product at Hovione, from API synthesis to final drug product. “We are excited to announce this new integrated offering, all at the same site where our scientists work together in the interface between particle engineering and final drug product for the benefit of an optimal product performance. This will allow us to support our customer’s inhalation projects at all scales and contribute to accelerate drug development and manufacturing timelines,” said Filipe Gaspar, Vice President R&D.    “These investments are driven by significant client demand, since the market is looking for integrated inhalation product development solutions that reduce program risk and complexity. Hovione has all the ingredients for an outstanding partnership starting from clinical programs and into commercial supply.” Added Frédéric Kahn, Vice President Marketing and Sales. Based on more than 20 years of experience in inhalation, Hovione can speed up your inhalation drug development, from a very early stage to a late development stage. Working with Hovione allows partners to take advantage of cutting edge particle engineering technologies and state of the art analytical facilities operated by highly skilled and responsive scientists.   About Hovione Hovione has over 58 years of experience as a CDMO and is currently a fully integrated supplier offering for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs and is able to support highly potent compounds. For generic pharmaceutical customers the company offers niche off-patent API products. In the inhalation area Hovione is the only independent company offering a complete range of services.

Press Release
Hovione announced that a new MG2 Tekna Precision Capsule filling unit is now online in its Portugal facilities

Hovione strengthens Inhalation Services portfolio

Jan 24, 2018

Energy-efficient compressors and visualisation software have given Cork-based pharmaceutical firm Hovione more control over operating costs and energy use, writes Kenneth Lloyd. Hovione, a Cork-based pharmaceutical firm, has realised multiple benefits from leasing a high-end compressed air system under a lease agreement. The Portuguese pharmaceutical firm acquired its Cork site in 2009. It was a state-of-the-art facility although, inevitably, the company inherited some older equipment. In 2015, it was apparent that the compressed air system needed to be replaced due to inefficiencies and reliability concerns. However, the company had a preference for leasing, as opposed to buying, the equipment in this instance. It appointed compressed air solutions experts, O’Neill Industrial, to provide a new compressed air system under a lease agreement. The benefits of leasing the equipment in contrast to buying were multiple for Hovione: it has...   Read the article

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Engineers Journal, December 5, 2017

Economic and environmental benefits from energy-efficient compressed-air system

Dec 05, 2017

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