• International regulators provide guiding principles for COVID-19 clinical trials

    EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around the world have jointly developed this statement to step up global collaboration to facilitate and expedite the development and evaluation of therapeutics, diagnostics and vaccines against COVID-19.
  • High demand for protective garments for the medical sector: Reifenhäuser converts another pilot line for production

    The Covid-19 crisis puts global production capacity for hygiene products to a severe test. In March Reifenhäuser has temporarily produced metlblown to produce roughly one million face masks a day at its Technology Center. The company has now converted another pilot line for production. The first batch produces 110 metric tons of protective film for a global leading manufacturer for medical coveralls for use in hospitals. The increased demand is currently very high for coveralls worn to treat highly infectious coronavirus patients. This volume is sufficient for about 1.2 million coveralls.
  • Fast and Furious: Pharmaceutical Company Makes and Packs Hand Sanitizer in Record Time


    When a coronavirus pandemic is underway globally and there’s a widespread and shortage of life-saving hand sanitizer, companies of all types and in all sectors have jumped swiftly into action to do what they can to provide help at a critical time. However, the from-scratch fast and furious effort achieved by HR Pharmaceuticals, York, PA, may be one for the record books. With the invaluable help of C-P Flexible Packaging (CPF), the pharma company accelerated from a standing start in late March to filling unit-dose packets of self-made hand sanitizer 10 days later. That record-busting turnaround is made even more amazing when you consider that the pharmaceuticals company had not made sanitizer before. Setting the humanitarian effort in motion was Colby Wiesman, president of HR Pharmaceuticals, who responded to the nationwide shortage of hand sanitizer. Although the company had not had any experience making or packaging hand sanitizer, Wiesman knew that its ultrasound gels have a consistency similar to hand sanitizer gels. He had a simple, but strong motivation: Wanting to help. Wiesman quickly set out to mass produce hand sanitizer gel and provide it to various groups within the local community that were in desperate need of the product. A few things had to happen quickly, and they did. First, HR Pharmaceuticals’ product development and sourcing teams swiftly came together to bring the idea to fruition. Although the alcohol needed to produce hand sanitizer was in short supply, the company managed to overcome this obstacle and rapidly pull together all of the raw materials needed to mass produce hand sanitizer gel thanks to Suite-K based in New York City. Notably, while HR Pharma had experience with flexibles before, it had not worked with C-P Flexible Packaging, the converter’s Director of Marketing Amanda Dahlby tells Packaging Digest. That was surprising because both companies have operations in York, PA, which is a highly fortuitous and perhaps necessary proximity given the timeframe. A flexible solution is logical. HR Pharmaceuticals needed a format they could package safely and get the hand sanitizer literally into as many hands as possible and in expedited fashion. Knowing that hand sanitizer is generally produced in large bottles or packages, Wiesman figured the sanitizer would be widely distributed to more people if packaged in single-use flexible packets rather than multi-use bottles. “As you may know, there is a big shortage of alcohol, so if we're filling into a 32-ounce bottle, it gets into your house, but it doesn't get into everybody else's," he says. "This is a great opportunity of producing single-use packets where they can be widely distributed." He also felt that single-use packets would also eliminate any potential for cross-contamination. It’s a format that hits the sweet spot for the company, which packages lubricants in tubes and packets for personal and medical/surgical use. That’s when HR Pharma reached out to C-P Flexible Packaging’s Clark, VP of sales. Clark immediately gained the full support of the converter. The customer created and delivered graphics for the new hand sanitizer packets in one day, and C-P Flexible Packaging expediently delivered first order of printed rollstock. Packaging Digest is told that the supplier had the raw materials on-hand, a 2.25-mil lamination with moisture and oxygen barrier properties that is also designed to seal through contamination. It was 10 days from Wiesman’s first contact with C-P Flexible Packaging that his company started packaging the gel. Each packet holds 3 grams of hand sanitizer, and HR Pharmaceuticals is filling from 4 to 6 million packets weekly for six weeks on vertical form-fill-seal machinery at the York facility. In addition to making this product available for sale through the national medical distribution network, the product is being donated to local front-line workers like police departments, fire stations, EMTs, prisons, courthouses, and more. Says Wiesman, “We are constantly pursuing opportunities that do good for the community, doctors and patients we serve while doing good for our business and associates. We were thankful that C-P Flexible Packaging bent over backwards to help us get the product into the literal hands of those who need it, with lead times that are unheard of in this industry. Seeing our internal associates and external partners come together for this noble project has been one of the greatest joys of my professional career.” This story may not end. Even as the planned six-week production run winds down, HR Pharmaceuticals is considering adding hand sanitizer to its standard portfolio, according to C-P Flexible Packaging’s Dahlby. To read more, visit Packaging Digest's archived listing of COVID-19 articles.

  • Plastic packaging replacement for Mettler Toledo InLab® sensors


    Our approach: Easy setup corrugated cardboard box DSS Plant Oftringen (Switzerland) created a single-material solution which is easy to set up without any additional inlays. Results: • Monomaterial solution – corrugated cardboard • Easy to recycle – better environmental protection across the supply chain • Easy to set up which leads to higher efficiency • Packaging fit for several sizes of the product • Lower cost and lower complexity • The solution won the World Star and Swiss Star Packaging Awards in 2016.

  • Dispenser is a Sweet Solution


    The original polystyrene (PS) construction of the lid and container has been replaced with a dispenser made entirely out of PP, which greatly increases the pack’s ability to be recycled. Equally important, the new dispenser offers the same durability and ease of use to ensure effective product protection and consumer convenience. The dispenser also retains the distinctive attractive design of the original to create maximum on-shelf appeal. The high gloss finish can be fully customised for effective brand differentiation, including individual colour matching, printing and sleeving. The side-actuator ensures ease of use for the consumer. The Bramlage Sweetener Dispenser 2.0 is available in two sizes, with a capacity for 650 or 1200 tablets up to 5mm in diameter and 2mm in depth.

  • How patient preferences are changing the design of drug delivery devices


    The following insights detail which preferences are driving the evolution of drug delivery device design. Adding ease to applications From using implants for contraception, to getting insulin injections at the dinner table, to using a wearable device to administer chemotherapy in the comfort of home, applications for drug delivery are largely being driven by patient preferences. Not only do these growing number of applications improve the patient experience, they also empower patients to play a more active role in managing their medications.2 Key takeaway: Drug delivery devices are increasingly designed to make compliance easier for patients, including new applications to help patients manage their medications on their own terms. Offering more flexibility in autoinjectors Produced by the millions, pens and autoinjectorscontinue to evolve due to a variety of factors, including the emergence of new biologics that require strict specifications for packaging and delivery. At the same time, patients are seeking more options to self-administer medications on a less-frequent basis, which is driving a wider variety of treatment options and releasing formulators from having to conform to <1mL dosage requirements.2 Key takeaway: Even in the well-defined pen and autoinjector market, we are seeing greater demand for ready-to-use drug delivery solutions that work with the latest biologic medications. Controlling where and when drugs are administered Even though prefilled syringe systems are still a primary packaging option, there is increasing demand for cartridge-based systems as dosage volumes increase and more patients administer their own medications. Using a prefilled, cartridge-based system empowers patients to take greater control by managing more of their care at a time and place that works for them, such as at home instead of a hospital.2 Key takeaway: Patients are looking for flexibility when it comes to larger-sized doses, making packaging of prefilled cartridges an increasingly popular option for drugs that require doses up to 10mL. Using technology to improve compliance Intelligent, wearable delivery systems offer another advantage for patients looking for more freedom and flexibility in their drug regimen. These devices use a smartphone connection to track and report injections to healthcare providers, sending helpful reminders to patients and alerts to their doctors when doses are missed. Wearable devices also offer other advantages over traditional autoinjectors, including greater flexibility to modify dosing and delivery times, as well as the ability to monitor patient adherence.1 Key takeaway: Packaging for drug delivery devices is becoming more user-centric, using technology to help patients minimize risk, improve compliance and support better health outcomes. Taking a holistic approach to drug delivery design As patients become more involved in managing their treatment plans and administering their medications, manufacturers are responding by applying human-centered design principles to injectables. Patients are demanding devices that are reliable and easy to use, with instructions that are easy to understand and applications that are as pain-free as possible.1 This more holistic approach helps to ensure the medication, device and patient experience work in harmony to support the drug delivery goals of patients and providers. Whether your project requires a single machine or a complex, large-scale integration, you need a partner with deep industry experience to help you increase patient safety while meeting FDA regulations. Let MGS solve your toughest challenges. We'll deliver a comprehensive solution that optimizes your production while minimizing your risk. Contact us at info@mgsmachine.com or request more information below.

  • Emer Cooke nominated as new EMA Executive Director

    The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. At an extraordinary virtual session on 25 June, the Board selected Emer Cooke from a shortlist of candidates created by the European Commission. Ms Cooke will now be invited to give a statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 July 2020. The appointment of the new Executive Director will only be made after that meeting.

  • First COVID-19 treatment recommended for EU authorisation

    EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.
  • Dr. Gustav Klein and MG2: the FAT between distance and reality


    Three days to test a capsule filler for phytopharmaceutical and nutraceutical products: a success signed by Italy and Germany joint work! Read the ITALIAN version One of MG2 first goals consists in reaching the customer by providing the best technical solutions. This goal has become even more strategic during the present worldwide spring 2020 crisis, which severely limited the movement of both people and goods. MG2 has successfully overcome this difficulty thanks to remote working technical solutions, chosen among the most consolidated office automation tools. Indeed, with Microsoft Teams, the video conferencing and Office 365 package remote working tool, MG2 can offer technical assistance, commercial support and advanced solutions, by using a familiar tool applicable to any business context. With this technology MG2 successfully carried out the first remote testing. This is the case of the Factory Acceptance Test run with the customer Dr. Gustav Klein GmbH & Co. KG, a company of the Alpen Pharma Group, that is specialized in the production and distribution of herbal medicinal and homeopathic products based on traditional knowledge with benefit of state-of-the-art technologies and equipment. Exporting to over 20 countries worldwide, the company works closely with national and international pharmaceutical companies as valuable contract manufacturer. Dr. Gustav Klein offers the best solutions thanks to the partnership with leading market suppliers of technical equipment that share their values ​​of sustainability, trust and tradition such as MG2. The machine at the centre of the remote FAT and the partnership with MG2 is an MG Compact capsule filler, with a maximum speed of 48,000 capsules per hour, equipped with two dosing units for powders and pellets with relevant dosing size parts, two capsule transport size parts and a statistical weight control system model SWC. This MG2 technology will allow to fill capsules with phytopharmaceutical and nutraceutical products. Dr. Gustav Klein bought the capsule filler despite the COVID-19 crisis. That is why a remote procedure had to be defined to both run the FAT and carry out product validation. FATs are usually carried out at the MG2 headquarters in the presence of the customer, who checks the accuracy of both capsule filler operation and size change-over, who can touch the capsules and checks their integrity. The order is reviewed step by step, showing the customer the consistency between technical documentation and the supply. The recent hindrances to the movement, however, have forced MG2 to identify new solutions based on the integration of multimedia technologies with technical expertise of the Company staff. “In this first remote FAT we used two video cameras,” says Eng. Fabrizio Buffoni, MG2 Area Manager, “one fixed and one on the operator. Wearable technology allows MG2 to show all the components purchased by the customer. The live procedure totally corresponds to the Factory Acceptance protocol that we usually apply. It allows, in fact, to verify that the compliance with the order and that the machine operates correctly. In this specific case, the customer asked to weight some of his capsules once a production batch was finished. The capsules were then collected in three stages during one hour of production: at the beginning, at the end and in the middle of the batch production, they have been weighed one by one, subsequently emptied and weighed again. The goal”, continues Eng. Buffoni, “was to give the customer an evidence that the capsules had been filled as expected by him.” The remote procedure, which covers all the steps necessary for the correct execution of a FAT, involves sharing all the documents of both validation and order confirmation, strictly following what is displayed by the two cameras. The batch reports processed by the machine were made available to the customer in real time, thus overcoming the objective limits related to the physical distance. The test recording, lasting 3 working days of 8 hours each, is another tool that let the customer the possibility to objectively evaluate the test. “A key element of the FAT is the objective evaluation of the correct capsule filling” continues Eng. Buffoni, “an aspect which, in the case of the customer Dr. Gustav Klein, was highlighted by two specific tests: the SWC weight control system, which tests a capsule every 20 seconds and it was part of the supply, and a further statistics check requested by the customer. Specifically, we manually weighed the capsules on a scale in front of the camera, thus ensuring maximum reliability and objectivity of the filling process “. Furthermore, with the same remote technology, it was possible to verify all the machine documentation (user manual) and validation documentation, by connecting the customer and the MG2 specialist in charge. “Usually validations are part of the packages purchased by pharmaceutical companies. In order to produce a drug, in fact, the capsule filler must be validated according to specific regulations.” – continues Eng. Buffoni – “The customer can have his own validation procedures; alternatively, MG2 can supply them. Normally, nutraceutical companies are not particularly interested in validations. But this was not the case of Dr. Gustav Klein, who decided to acquire validations too, because he is a high-quality manufacturer of food supplements and homeopathic products: that’s why we could call him a parapharmaceutical supplier.” Quality, efficiency and proximity to the customer, well-known characteristics of the MG2 brand, have been enriched with the successful remote FAT for Dr. Gustav Klein.



    For this reason, it implemented all the indications provided for by the Shared Protocol on March 14, 2020 between the Government, Trade Unions and Trade Associations. In order to allow its employees and suppliers to access workplaces in compliance with the precautions that the current serious situation requires to adopt. Below you will find the main measures that Makro Labeling Srl has put in place to ensure the safety of its employees / collaborators for the benefit of the entire community of customers and suppliers and to guarantee - at the same time - the continuity of activities with our customers, where possible. In particular: The Committee for the verification and application of the rules established by the Shared Protocol was set up in the company. The Committee meets virtually every day to follow the evolution of the emergency and act accordingly. For security reasons, from the first day we reduced the organization of face-to-face meetings to a minimum, favoring remote communication tools such as webinars, skype calls, etc. We have activated the working mode in smartworking as much as possible and reduced the staff present in the production departments, using backward permits and holidays, always in such a way, however, to guarantee continuity of service. All our telephone numbers / contact points are manned, as usual. We confirm that, to date, no employee and collaborator of Makro Labeling Srl is affected by the COVID-19 virus and therefore subjected to restrictive individual health measures as required by the emergency protocol. For the protection of everyone's health, our office is currently not accessible to outsiders (suppliers can deliver, in compliance with company safety procedures, by agreement with the warehouse. For operational questions and specifics on current projects, we ask you to refer to your internal contacts at Makro Labeling Srl. We will take care of updating you with further communications in the case of new provisions that may be adopted following directives from the Competent Authorities. Cordial greetings Goito (MN), there March 24 2020

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