A new study by DuPont Personal Protection which assesses the performance of reusable garments for cleanroom applications could lead to a radical change in controlled environment practices. The results, which the company has published in a whitepaper, confirm that reusable garments are vulnerable to damage from laundering and sterilization – and that the evidence that a garment has been compromised is often invisible to the naked eye.
The results could have far-reaching implications, particularly for those working in the medical devices manufacturing, pharmaceutical, biotechnology and research industries. Still a relatively new introduction, single-use textiles such as Tyvek IsoClean reduce the risk of contamination and will become an increasingly important element of any contamination control strategy.
Reusable garments used in sterile and aseptic production require repeated laundering and sterilization cycles to maintain their effectiveness, using such techniques as gamma radiation. Physical property data are often available for new cleanroom garments: however, there are less data available throughout the entire garment life. DuPont’s new study is intended to address this information gap.
Says Jean-François Teneul, Global Business Manager for the Controlled Environments section of DuPont Personal Protection: “Most contamination within aseptic processing areas is caused by the humans working in the cleanrooms. When selecting reusable garments for use in controlled environments, it is important to understand how they will perform over their intended lifecycle. In addition, for potent product handling, cleanroom garments must perform a dual role: not only to protect the product from the operator, as with aseptic processes; but also to protect the operator from the hazardous chemicals. We felt it was necessary to provide these professionals with data on which to base a more informed choice.”
DuPont conducted the study to map the properties of reusable garments typically used in cleanrooms when exposed to repeated laundering and gamma radiation, in order to learn how the performance of those garments changes with each cycle. The scientific study focused on fabric performance and examined garment properties such as polymer structure, permeation, tear strength and Bacterial Filtration Efficiency (BFE) to determine how they are negatively impacted by cleaning and sterilization regimes over time. The tests, which were undertaken by third party laboratories, revealed significant impacts on critical aspects including protection of the process and the wearer, durability and comfort.
Among the key findings were:
- Changes in polymer structure: while gamma radiation is effective for sterilization it can also impact polymers that make up reusable garments. Changes to the polymer matrix will ultimately affect the properties of the fibres that make up the garments, and the garments themselves.
- Breathability and barrier: barrier decreases while air permeability increases, which means the garment is providing less protection over time.
- Particle shedding: as exposure to gamma radiation and laundering increases, so does the amount and variability of particle generation.
- Tear strength: increased gamma radiation and laundering exposure reduces tear strength.
- Bacterial Filtration Efficiency: with a BFE higher than 98%, single-use textile Tyvek IsoClean has the ability to better filter out bacteria compared to reusable cleanroom textile, which has a BFE below 70%.
These changes are not always visible to the naked eye, so visual garment inspection alone may not be sufficient to understand garment performance. Based on these findings, the study offers the following recommendations:
- Consider performance data over the entire garment life cycle.
- Enact testing protocols to monitor the performance of garments as they age, based on the risk assessments and needs of each individual cleanroom.
- Establish criteria for taking garments out of service when they no longer meet functionality requirements.
In conclusion, Jean-François Teneul says: “Based on the results of our scientific study – and in the context of the draft version of the revised GMP Annex 1, which includes more Quality Risk Management (QRM) principles – the focus will have to be not only on the behaviour and gowning procedure of the personnel, but also on the performance of the cleanroom clothing system and the specific risk assessment of cleanroom garments. The study data will allow the responsible person to make a proper assessment of the contamination risks and costs involved in their applications and to decide whether reusable cleanroom garments or single-use cleanroom garments are the right choice.”
The whitepaper ‘To Reuse or Not to Reuse: A Life Cycle Assessment of Reusable Garment Properties’ contains full details of the methodology and results from the reusable garment study. It is available as a free download here: www.tyvek.co.uk/invisible
Merck, a science and technology company, announced that Susumu Kitagawa, Professor at the Institute for Integrated Cell–Material Sciences at Kyoto University, Japan, has been named the sixteenth recipient of the Emanuel Merck Lectureship. He is being recognized for his pioneering scientific work in the field of metal organic frameworks (MOFs). His fundamental contributions to the development of this innovative class of nanoporous materials could lead to new ways of capturing, storing and releasing gases. Broadly speaking, MOFs could contribute to improving the state of our planet by helping to fight climate change.
“I am thankful for the honor bestowed upon me today for my work as a scientist,” said Kitagawa on receiving the news about this distinction. “My big dream is to synthesize very important chemicals such as amino acids directly from an ubiquitous element: air. When you think of it, all the elements are right there: oxygen, carbon, nitrogen, but also hydrogen in moisture. I’m not sure I will actually be able to achieve that, but I can encourage young researchers in this direction.”
“We are honoring an outstanding scientist whose contribution to mankind might not be visible to everyone now, but will be sooner or later,” said Klaus Griesar, Head of Science Relations at Merck. “This science prize not only serves to promote scientific exchange with internationally recognized researchers, but it also provides insights into front-line scientific research. It fits in well with Merck as a science and technology company and complements chemical research at the Technische Universität Darmstadt.”
The Emanuel Merck Lectureship was jointly established by Merck and the Technische Universität Darmstadt in 1992. It recognizes globally renowned scientists who have made superb contributions to chemical and pharmaceutical research. From 1993 to the present day, the award has been granted to 16 eminent scientists from all over the world. The prize, worth € 30,000, was presented to Kitagawa on May 13, 2019 during a public lecture at the Hörsaal- und Medienzentrum at the Lichtwiese campus of TU Darmstadt. At 5 p.m., the prize winner was hold a lecture entitled “Welcome to Small Spaces – Chemistry and Application of Porous Coordination Polymers /Metal-Organic Frameworks”.
Kitagawa’s development of nanoporous materials could lead to new ways of capturing, storing and releasing gases like in a cage with bars so small as to lock gas molecules inside it. In essence, metal organic frameworks (MOFs) are such cages. They combine metallic knots and organic ligands that hold them together. By combining different types of metals and ligands, the size and shapes of the pores can be controlled, which means MOFs can be used to capture or release gases on a molecular scale.
The potential applications are very wide, but certain fields are already quite promising, such as gas storage (typically for methane, hydrogen or CO2 ), gas separation (which would be useful in the field of air quality, for capturing harmful molecules for example), gas transformation – using the catalytic properties of MOFs – as well as for making high-sensitivity gas sensors. Capturing and re-using gases in these cages could help develop clean technologies to tackle climate change and open up new possibilities in energy storage.
Apart from the Emanuel Merck Lectureship, Merck honors science and scientist with many other awards. The latest addition to this is the Future Insight Prize, which was announced in July 2018 and will be awarded for the first time in July 2019. Merck aims to give up to € 1 billion annually for the next 35 years to incentivize people whose work has enabled significant progress towards making this vision a reality by discovering new ground-breaking science or by developing enabling technologies. This year’s prize will be granted for a visionary product to protect humanity from a new pandemic threat.
Merck, a science and technology company, held its 24th Annual General Meeting today at the Jahrhunderthalle in Frankfurt am Main. After Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, briefly recapitulated the anniversary year 2018, he presented the company’s plans for future growth to Merck shareholders.
“Science and technology are transforming our world at lightning speed and we at Merck are helping to shape this transformation. Science is at the heart of everything we do,” said Oschmann. “We performed well in 2018, which was a challenging year. In 2019, we want to resume growth for all key figures: sales, EBITDA pre and EPS pre. Our objectives are ambitious yet feasible since we’ve created a solid foundation.”
As already reported in early March, Merck generated net sales in 2018 of € 14.8 billion, an increase of 2.2%. EBITDA pre, the company’s most important earnings indicator, declined by -10.5% to € 3.8 billion. This was largely due to negative exchange rate effects. Earnings per share pre (EPS pre), which is decisive for the Merck dividend, decreased in 2018 by -13.9% to € 5.10. Nevertheless, in the interests of dividend continuity, Merck is proposing to the Annual General Meeting a dividend of € 1.25 per share as in the previous year. As previously announced, Merck expects moderate organic growth of Group sales in 2019. For EBITDA pre, the company forecasts a pronounced organic percentage increase in the low teens range in 2019.
The company has also clearly formulated its long-term objectives and is resolutely focusing on them. In the Healthcare business sector, as of 2022 Merck aims to achieve around € 2 billion in sales annually with newly launched medicines or compounds still in its Biopharma pipeline at the present time. In 2018, Merck generated sales of € 160 million with its two new medicines, the immuno-oncology drug Bavencio and Mavenclad for the treatment of multiple sclerosis. At the end of March 2019, Mavenclad was approved by the U.S. Food and Drug Administration (FDA) and thus in the largest single regional market for this medicine.
The firm has also filed for further approvals of Bavencio. The regulatory authorities in the United States, Europe and Japan are reviewing Bavencio in combination with Inlyta from Pfizer in the treatment of patients with advanced renal cell carcinoma. In addition, an important element of Merck’s strategy in the Healthcare sector is the alliance entered into in February with GlaxoSmithKline to co-develop and co-commercialize bintrafusp alfa (M7824), an immunotherapy from Merck currently in clinical trials. The agreement has a potential overall value of up to € 3.7 billion. Overall, eight clinical programs for this novel immunotherapy will be in progress or initiated this year.
In its Life Science business sector, Merck intends to continue to achieve above-market growth. Merck sees great potential particularly for the business with pharmaceutical companies, which is the main focus of the Process Solutions business unit. E-commerce is also playing an important role and already accounts for a large portion of Life Science sales. In addition, Merck is investing in growth fields such as bioprocessing technology for drug manufacturing. The company is forging ahead with promising new technologies, for example the BioContinuum platform. With BioContinuum, Merck wants to significantly simplify and accelerate the complex manufacturing process for biotech medicines by melding formerly separate steps into one continuous process for its customers in the coming years.
In Performance Materials, Merck intends to expand its position as a leading provider of solutions for the electronics industry. After 2019, the company is aiming to increase sales in this business sector by an average of 2% to 3% annually. On
April 12, Merck signed a definitive agreement to acquire Versum Materials for US$ 53 per share. The business combination is expected to significantly strengthen the Performance Materials business sector. The U.S. company Versum is one of the world’s leading suppliers of innovation-driven, high-purity process chemicals, gases and equipment for semiconductor manufacturing. The transaction is expected to close in the second half of 2019, subject to the approval of Versum stockholders at a Versum special meeting, regulatory clearances and the satisfaction of other customary closing conditions. “Versum will broaden our portfolio. Our competencies are highly complementary. Together, we can offer our customers more. This is very important because the digital revolution has only just begun and we want to considerably advance it further,” Oschmann said to shareholders.
Furthermore, Merck is also working to build new digital businesses beyond its three business sectors. The joint venture Syntropy, which Merck plans to establish with Palantir Technologies, wants to help scientists use scientific data better and securely. By enabling researchers to structure data from various sources and to analyze it via pattern recognition, Syntropy initially aims to considerably accelerate cancer research. Additionally, Syntropy will enable researchers to exchange and trace data reliably, with users always retaining full control of their data.
Fight metabolic diseases
Servier collaborates with Harvard researchers
Servier and Harvard researchers will embark on a three-year preclinical research project where the ultimate objective is to develop therapeutics targeting the microbiota for the treatment of type 2 diabetes and NAFLD. The work will be conducted by a multidisciplinary team of researchers from both parties. The research team at Harvard University will be led by Emily P. Balskus, Professor of Chemistry and Chemical Biology, and the team at Servier will be led by Philippe Delerive, Head of Research for Cardiovascular and Metabolic Diseases. The collaboration combines the expertise of Servier researchers in the field of metabolism and drug development with Prof. Balskus’ expertise in chemical discovery relating to the gut microbiome. Together, the parties hope to make important advances in understanding disease biology and to use emerging technologies to develop new treatment options for diseases with high unmet medical need.
“Gut microbiota is an untapped resource for the identification of novel targets in the field of metabolic diseases. It opens up new perspectives for the development of increasingly precise and personalized innovative therapies. The close collaboration between our researchers and academic researchers from Harvard represents a major step in this direction, for the ultimate benefit of patients,” stated Servier Group Executive Vice-President Research & Development, Claude Bertrand.
Non-alcoholic fatty liver disease (NAFLD) affects over 25% of the world’s population. The condition, in which too much fat is stored in the liver, is very often linked to excess weight and/or type 2 diabetes. This, in turn, is due to the build-up of fatty acids and scar tissue, which can lead to steatohepatitis (NASH), cirrhosis and, in some cases, to the development of liver cancer. Currently there are no therapies available to patients for this disease.
This collaboration is a project under the strategic alliance established between Servier and Harvard University in 2017. Under the terms of the alliance agreement, Servier will support multi-year research projects initiated by Harvard faculty and focused on the development of innovative treatments in its therapeutic fields of expertise. Servier selected this project through a call for proposals.
Servier has been involved in the research and development of innovative therapeutics against non-insulin diabetes (type 2 diabetes) for over 40 years. Identifying new therapeutic targets in this field is one of Servier’s priorities, as well as research of specific therapeutic solutions to diabetes-linked complications such as diabetic nephropathy or non-alcoholic fatty liver disease.