• Haselmeier receives Medical Device Master File number for D-Flex product platform

    News: 
    A device master file provides regulatory authorities with proprietary data about a material, component or manufacturing process. It enables the company submitting the information to the FDA to comply with regulatory requirements for trading in the USA while protecting its intellectual property from potential partners, competitors and customers. Moreover, it facilitates combination product approvals for multiple applications using the same device. Haselmeier formally submitted the MAF for D-Flex in late 2019, following productive discussions with the FDA. Pharmaceutical customers can now refer directly to the master file number MAF3202 when submitting their own products based on the D-Flex pen for approval, greatly simplifying and streamlining the FDA clearance process. With this documentation in place, customers worldwide will be able to leverage the patent-registered D-Flex disposable pen system for their combination product development. This versatile, reliable platform is configurable for several fixed doses, bridging the gap between fixed and variable-dose pens, and can support pharmaceutical customers from clinical trials through to commercial use. Konrad Betzler, Vice President Quality and Alexander Ball, Vice President IT, were involved in the FDA talks. As Mr Betzler comments, “We are delighted that global pharmaceutical customers can now benefit from this device master file submission. The file is a ‘living document’ that will evolve over the months and years ahead, in line with the latest D-Flex capacity and capability enhancements.” In addition to the D-Flex injection system, Haselmeier also presented its D-Flex Connect system to the FDA. D-Flex Connect comprises the D-Flex pen, a smart cap and an innovative, future-proof software platform. This development illustrates Haselmeier’s active commitment to digitalization. Following positive initial conversations with the FDA, Haselmeier plans to compile the data for either 510(k) or IDE submissions by the end of 2020, with the goal of enabling its customers to deploy D-Flex Connect in clinical trials. As Mr Ball remarks, “We are grateful to the FDA for their active and encouraging participation in the meetings held so far. This is an important step for Haselmeier’s expansion into smart data management for therapy efficiency by building the D-Flex Connect platform.” About Haselmeier Haselmeier, headquartered in Switzerland, is a leading provider of subcutaneous injection system solutions. As a reliable development partner, Haselmeier provides customized solutions from concept design and prototyping to engineering and industrialization, including pharmaceutical packaging solutions. Haselmeier empowers safe self-administration of liquid drugs through the development and manufacture of intelligent injection devices that improve therapy efficiency. Moreover, the company is actively developing innovative connected solutions that will help shape the future of smart healthcare. Haselmeier currently employs 240 staff members in six countries with distribution offices in Europe, the US and India, and state-of-the-art manufacturing plants in Buchen, Odenwald, Germany, Dnešice, Czech Republic and Bengaluru, India. Haselmeier unites 100 years of experience in medical technology. For further information, please visit www.haselmeier.com. Contact Silvia Wilkes, Marketing Coordinator s.wilkes@haselmeier.com
  • Dr. Marco Linari becomes new CEO of the Haselmeier Group

    News: 
    In addition to his role as Chair of the Executive Team, Dr. Marco Linari will be responsible for Marketing and Sales, Project Management, Quality Management and IT. As Executive Team Dr. Marco Linari, the Chief Financial Officer (CFO) Mark Bleckmann and the Chief Operations Officer (COO) Matthias Meissner are leading the Haselmeier Group. Dr. Marco Linari studied chemistry and economics and holds a doctorate in biochemistry. After a successful track in strategy consulting, Dr. Marco Linari held national and international leadership roles within the Merck Group in the last 15 year, lastly as CEO of Allergopharma. Through his experience and knowledge of the pharmaceutical and med tech sector, he knows the requirements and needs of the pharma and Med Tech industry. The Haselmeier Group will benefit from his expertise and will have an excellent perspective for its successful further development.
  • Aptar Requests U.S. FDA Emergency Use Authorization for N95 Filtering Facepiece Respirator Decontamination with ActivShieldTM

    News: 
    In this simple disinfecting process, the N95 mask and a small strip of Aptar’s ActivShieldTM are placed inside any commonly available one-gallon plastic bag. The strip releases a controlled amount of chlorine dioxide inside the sealed bag to decontaminate the N95 mask. The process takes only three hours until the mask is ready to wear again. It can be performed on-site at the local hospital where the mask is being used. Aptar has submitted its safety and effectiveness data to the FDA for EUA review. The company is working to provide approximately four million ActivShield strips per week and is working to expand its production capacity with the intent to deliver ten million per week by the end of April. “We are extremely encouraged by the promising data generated so far and are eager to deliver this technology to the front line and support the fight against the pandemic,” said John Belfance, President of Aptar CSP Technologies. If the FDA approves the EUA, then ActivShield will immediately become available for this important use. Chlorine dioxide has been widely used as a disinfectant in different industries, including the paper industry, drinking water treatment, food processing, and medical equipment. Aptar’s delivery mechanism uses the disinfecting properties of chlorine dioxide in a controlled sustained release within a contained volume. This innovative patent pending technology can efficiently and effectively disinfect N95 masks used by healthcare workers and first responders. “Aptar’s technology provides a unique, simple, and effective way to help solve the critical problem of PPE shortages we’re currently facing,” said Stephan Tanda, Aptar President and CEO. “We are aiming to provide a solution that is not only fast, but it does not require special equipment or training, making it potentially accessible to the wider healthcare community. This could enable healthcare workers to retain and disinfect their own facemask, helping to maintain continued proper fit to their face.”
  • PharmaLytica will be held in the heartland of Pharma industry in India

    After a very successful 6th edition, the 7th edition of PharmaLytica will be held in the heartland of Pharma industry in India i.e. Mumbai from 9-11 Sep, 2020 at the Bombay Exhibition Centre in Goregaon (E). At this international trade fair, Pharmaceutical community can pick up on the latest industry trends, innovations and do business with Pharma Machinery & Packaging, Lab Analytical & Cleanroom and Pharma Ingredients segments. For the first time ever, the 6th edition will see a new pavilion for API and Excipients. PharmaLytica is evolving as the leading marketplace for products and services along the entire value chain in niche segments within the Pharma industry. Key Highlights of PharmaLytica: • 300+ exhibitors • 12000 sqm of business space • Pre fixed B2B meetings • API and Excipients pavilion • Stay abreast with latest industry trends & innovations • Meet and network with leading global suppliers • Ideal platform for you to grow your business in pharmaceutical capital of India • It is where the industry's key players and decision-makers meet.
  • Aptar Pharma is an Outstanding Issue Sponsor in April’s ONdrugDelivery

    News: 
    “Is Now the Time to Shake Up the pMDI Environment?” by Chris Baron, Director Business Development, Rx, EMEA at Aptar Pharma. This article explores how the use of propellants in pressurised metered dose inhalers has evolved – and how alternative propellants could be a catalyst for greater patient adherence. “Developing an In Vitro Dissolution and Release System for Orally Inhaled Drug Products” by Rob Price, Chief Scientific Officer, Nanopharm Ltd, an Aptar Pharma company. This article critiques regulatory routes for the development of generic OINDPs, runs through recent announcements and developments of note from regulators, and describes how Nanopharm has pioneered the concept of structural Q3 equivalence. “Be prepared. The Importance of Training and Onboarding Programs for Intranasal Rescue Therapies” by Joe Masci, Executive Director of Business Development Noble International, an Aptar Pharma company. With a recent resurgence in nasal drug repurposing, this article looks at the importance of training and onboarding for intranasal rescue therapies.
  • Aptar and Sonmol Partner to Develop Digital Platform for Respiratory-Related Therapies

    News: 
    This collaboration will initially focus on bringing together connected drug delivery devices and the digital platform for asthma and chronic obstructive pulmonary disease (COPD). Aptar Pharma and Sonmol will work together on expanding Sonmol’s platform services to enable remote patient monitoring, improve patient and physician interactions, increase patient engagement and adherence, and improve health outcomes. The partnership will work with pharmaceutical and healthcare partners to accelerate the development, manufacturing, commercialization and supply of digital respiratory medicines, diagnostics and patient support services in China and other Asian markets for marketed and pipeline drugs. The collaboration significantly bolster’s Aptar’s digital health offerings in Asia by combining Aptar Pharma’s expertise in connected drug delivery device development, innovation and quality manufacturing together with Sonmol’s connected devices, data platform and patient management services. Stephan Tanda, Aptar President and CEO, stated, “We are pleased to partner with Sonmol to improve health outcomes by combining Aptar’s breadth of regulatory experience, quality focus and connected drug delivery device innovations with Sonmol’s patient adherence platform.” Xiangwei Gong, President of Aptar Asia, added, “We look forward to furthering digital respiratory medicines, diagnostics and patient support services in China and other Asian markets.” Sonmol, which is based in Shanghai, was founded in 2014 by Luffy Lv and a core team of software, algorithm and medical experts. Sonmol’s strategic focus is on chronic respiratory diseases, which is second largest disease category in China. Government initiatives to push for early detection and prevention measures for chronic respiratory diseases strengthen the case for Smart Inhalers and connected devices as platforms to improve health conditions in patients, rectify the use of medications, improve inhaler adherence and provide better treatment outcomes for patients. Added Luffy Lv, CEO of Sonmol, “Aptar Pharma has a well-established position worldwide in drug delivery technologies across the whole value chain. Collaborating with Aptar will help us expand and speed up clinical application and commercialization of Sonmol’s innovative products. I look forward to more in-depth and innovative exploration and collaboration between Aptar and Sonmol in the field of drug and disease digital management in China and worldwide.” Gael Touya, President of Aptar Pharma, commented, “This partnership with Sonmol continues to develop our strategy in digital health, building platforms for customers and their patients worldwide. We look forward to our future collaboration.” Aptar Pharma and Sonmol will co-build the ecosystem of connected healthcare devices and services for China and other markets, and collaborate on device development and manufacturing for local and global markets. Sonmol will focus on data and software development for China.
  • The 53rd manufacturing bean jam basic course

    News: 
    This event was held for customers who purchased Kajiwara's confectionery machine. After learning the theory of bean jam, in the 1st floor test room, we practiced the small unmanned bean jam line hybrid hybrid machine electromagnetic steam production using the electromagnetic steam and the unmanned bean jam production in the unmanned bean jam unit. I was able to finish it.
  • FOBA supports manufacturers with webcasts and flexible marking solutions during the crisis

    FOBA supports manufacturers with webcasts and flexible marking solutions during the crisis Fast provision, uncomplicated financing models and extended service make it easier to cope with production peaks In FOBA’s webinar series, laser marking experts offer direct part marking backgrounds and practical application knowledge Laser marking ensures safe traceability as well as counterfeit protection Selmsdorf, April 2020 – FOBA Laser Marking + Engraving (Alltec GmbH) offers support for manufacturers that need to cope with special requirements in the Corona crisis.

  • Expanded Capacity for Vial & Syringe Packaging at Keystone Folding Box Co.

    Amid increased demand from biologics and vaccines sectors, Company invests in additional die cutting and gluing machinery, expanding production capacity and allowing for expedited turnaround. Newark, NJ – Keystone Folding Box Co., a designer and manufacturer of paperboard packaging solutions, has incorporated new die cutting and gluing equipment into its production facility. The infrastructure investment increases the company’s production capacity of vial and syringe packaging by 25%, and accommodates shorter lead-times.
  • Legacy Pharmaceutical Packaging Acquires Multiple Blister Production Lines from McKesson RxPak

    Company also adds bottling and pouching equipment in anticipation of heightened demand.
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