Tekni-Plex granted patent for first-of-its-kind Sniff Seal technology

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Tekni-Plex has been granted a patent for its Sniff Seal® technology which is the first liner to enable scent permeation through an induction seal closure liner without affecting the seal or compromising the contents.

Brand owners are constantly looking for ways to create product differentiation. Consumers are also interested in enhancing their purchasing experience. Sniff Seal technology is an ideal way for the consumer to experience a scent in the retail aisle without compromising the seal or the product contents. A wide variety of product categories, including food, beverage, personal care, cosmetics can benefit from the technology.

“There are many instances where consumers want to know what a product actually smells like before putting it in the shopping cart. Unfortunately, there are times when consumers peel back seals or remove fitments to experience the scent before buying. When a package is returned to the shelf in a compromised condition, it is no longer sellable. As a result, the retail industry experiences a significant amount of loss annually,” explains David Andrulonis, senior vice president and general manager, Tri-Seal, a Tekni-Plex business unit.

Sniff Seal liner technology eliminates the problem because it provides the olfactory experience without removing the seal. This means that the tamper and/or pilfer evidence remains in place and the product integrity is maintained.

An extensive range of products can benefit from this technology. Imagine being able to experience the smell of fresh peanut butter or mango-scented shampoo or spring-fresh deodorant in a retail aisle without removing a seal or a fitment? That’s what Sniff Seal brings to the purchasing experience,” Andrulonis said.

Fareva opens its new analytical building dedicated to high potent technology

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Fareva has just opened its new analytical building dedicated to high potent technology on its site of Excella, Germany, welcoming 88 working spaces. This 7 m€ investment targets to support new chemical entities registration, quality by design studies, with the ability to handle molecules with an OEL < 1 µg/m³.

It will be completed in Q2 2019 with the addition of a Gerteis roller compactor that allows to manufacture up to 30 kg batches from clinical to commercial phases for 2,5 m€. It has been designed to be certified for Europe, Japan, Korea, USA and other markets.

Fareva APIs is also competing a major investment of 25 m€ on its French site of La vallee, to manufacture OEB4 APIs. First production is expected in August 2018.

Almac Group Recognised with CMO Leadership Awards

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced it has been awarded CMO Leadership Awards for the sixth consecutive year.

The CMO Leadership Awards recognises top outsourcing partners, determined by feedback from sponsor companies who outsource manufacturing. Each year, the awards are presented by Life Science Leader and Industry Standard Research (ISR) during an annual award ceremony which celebrates drug development and manufacturing.

Almac Pharma Services received three awards at the prestigious celebratory event held on 21 March in New York which recognised its capabilities, overall compatibility and outstanding quality at small pharma level.

The global organisation recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland. The new facility complements Almac’s existing global drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite.

Adam Schroeder, Director Business Development, Almac Pharma Services commented “Once again, we are delighted to receive these awards which recognises continued investment in our global capabilities and solutions. This achievement strengthens our commitment to better serve our clients, and ultimately patients worldwide, thereby maintaining our position as a global leader in the life sciences sector.

Duma Standard container now available with child-resistant Duma Handy cap made out of one component

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Gerresheimer presented its Duma Standard CR (child-resistant) container with Handy Cap CR at Pharmapack last month in Paris. This is the company’s first snap-on cap with child-resistant (CR) solution. The snap-on cap is a one-component-system compared to more conventional child-resistant screw-cap solutions that are made of two components.

“I’m a father myself and I know how curious children are,” says Niels Düring, Global Executive Vice President Plastic Packaging. “You have to be very careful because they’ll play with anything they can get their little hands on. So it’s vital for drugs to be supplied in childproof packaging.”

Only the 40 ml version of the new Duma Standard CR container is cur-rently available with the Handy Cap CR. Other sizes can be supplied upon request.

Children experiment with everything and that includes medicines – mummy’s tablets could well be some sort of tasty treat, after all. This means tablets should be stored out of the reach of children. This is much easier said than done, however. It is all too easy to leave a box of tablets behind on the kitchen table where your child can play with it.

Packaging like the new Duma Standard CR container with its child-resistant cap is designed to prevent young children from getting hold of items like medicines that could be harmful to their health. Many products that could pose a threat to young children’s health are required to incor-porate a safety device under national and international law. ISO standard 8317 (2015) applies in Europe and US 16 CFR section 1700.20 in the U.S.

ISO 8317 (2015)

ISO 8317 (2015) is the international standard for reclosable child-resistant packaging. It governs both pharmaceutical and technical chem-ical products.

The standard describes two test procedures, which any packaging to be tested must be subject to. One test is run with a group of up to 200 youngchildren aged between 42 and 51 months. They must not be able to open the packaging, which is filled with a harmless replacement substance. At the same time, a test group of older people aged between 50 and 70 must
be able to open and reclose it without imparing the child-resistant func-tion. Packaging will only meet the requirements of ISO 8317 (2015) if the tests demonstrate that they are safe for children and user-friendly for the elderly, as defined in the standard.

The test

During the test, children have an initial five minutes to try opening the packaging. Afterwards, they are shown how to open it once without any explanation. They then have another five minutes to try opening it.

The packaging is deemed child-resistant if no more than 15 percent of children are able to open it within the first five minutes. A maximum of 20 percent of children are permitted to succeed in getting at the contents of the packaging for the entire duration of the test.

If only a few young children manage to open the packaging, the test group could be reduced to fewer than 200 children as part of the sequen-tial evaluation process.

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Tests with older people aged between 50 and 70

During the test, the participants have an initial five minutes to try opening the packaging. They are not shown how to do so besides the instruction on the packaging. In the second phase, they only have one minute to try and open it. The packaging is deemed suitable for older people as long as at least 90 percent of the test group are able to open and reclose it again without imparing the child-resistant function within a reasonable amount of time.

The test group is designed to include 100 people, of whom 25 are aged between 50 and 54, 25 between 55 and 59, and 50 between 60 and 70. 70 percent of each of these age groups should be female.

The US 16 CFR section 1700.20 regulation also stipulates the requirements child-resistant packaging must meet. These are similar to the standards applicable in Europe but are even more extensive for medicines.

 

 

Plastibell : an expert in Medical Devices

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On February 7 and 8, Plastibell attended the Pharmapack show, a key event in the pharmaceutical packaging and drug delivery calendar.

Plastibell (headquarters in Izernore, France), is an expert when it comes to injection molding and assembly, producing a broad range of complex plastic products for different industries.
The company is internationally active with seven industrial sites in four countries.
The Healthcare Division accompanies its customers in the development of Medical and In Vitro Diagnostics Devices (MD/IVD), from the earliest design stage, right through production.

Stiplastics launches an adjustable spoon designed to dispense mini-tablets

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Always at the forefront of innovation, the Isère SME is anticipating rapid growth of this new galenic device.

Stiplastics, specialised in creating, developing and producing plastic solutions for the pharmaceutical industries and the health and e-health sector, has developed a new spoon which makes dispensing mini-tablets easy.

Very simple to use, this first multi-dispensing device can be used to dispense from 1 to 24 mini-tablets. Simply select the desired dose by dipping the spoon into the jar containing the tablets and then withdraw it filled with the prescribed number of mini-tablets. Any patient contact with the medicine is avoided, thus offering total hygiene and safety.

This new galenic solution, the micro-tablet, meets the obligation of the pharmaceutical laboratories to develop paediatric forms as imposed by the European Regulation (No. 1901/2006) which entered into force in January 2007 and which stipulates that, when the pathology is not specific to adults, any new medicine must also be offered in a paediatric version for the five following classes:

– Preterm infants
– New-born infants from 0 to 27 days
– Very young children from 1 to 23 months
– Children from 2 to 11 years
– Adolescents from 12 to 16 or 18 years.

“The studies we carry out and feedback from our customers, patients and health professionals have encouraged us to develop this spoon because we are convinced that the micro-tablet form is one that is going to develop strongly in the near future. Since it is the smallest solid form that can be administered individually, it allows subdivisions of the dosage and therefore a very accurate dose to be administered with a high concentration of active ingredients and few excipients. This has several advantages such as ease of use, a reduction in swallowing problems and the ability to adapt the dose according to physiological parameters, thereby reducing the risk of over or under-dosing. This is of particular interest in the treatment of rare diseases or in paediatrics. It also provides a solution for adults experiencing swallowing problems such as the elderly. This first device is ready for production and it is fully in line with our philosophy of facilitating and making the everyday life of patients and health professionals more pleasant” Virginie Delay, Marketing Director & STICARE BU Manager, stated.

Sanner and Amiko advance true medication adherence

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At Pharmapack Europe in Paris, Sanner and Amiko presented their cooperation for the development of smart add-on solutions for inhaled drug delivery systems. Sanner Ventures, parent company of Sanner GmbH and corporate venture capital office specializing in new technologies in the area of health and well-being, supports Amiko Digital Health Limited with a strategic investment. The funds will be used to expand Amiko’s flagship product, the Respiro platform, an innovative respiratory disease management tool.

 

 

Heading towards true medication adherence

On the operational side, Sanner GmbH, headquartered in Bensheim, Germany, will work closely with Amiko to incorporate the start-up’s patented sensor technology into custom add-on or integrated device solutions for pharmaceutical clients. “Sanner has profound experience in moisture protection solutions and custom-made primary plastic packaging, as well as in design for manufacturing and industrialization of drug delivery systems,” says Dirk Mähr, Managing Director of Sanner GmbH. “Together with Amiko’s digital Respiro Platform and unique sensor technology, we will transform our synergies into smart solutions for true medication adherence in respiratory care.”

Amiko, winner of the 1st prize at the IBM Watson AI XPRIZE annual Milestone Award 2017, is upgrading respiratory care with sensors and AI technologies. Amiko’s Respiro platform, which has recently received the CE mark for use with certain inhaler systems, enables real-time monitoring of medication use and patient health. The patented Respiro Sense sensors, which are attached to dry powder inhalers, not only track device usage. They also facilitate true medication adherence by ensuring the medication is administered in the right way following the right technique. “Our digital health tools assist healthcare professionals and empower patients to achieve better respiratory treatment results,” says Duilio Macchi, CEO and Co-Founder of Amiko. “Together with Sanner we will advance our mission to upgrade respiratory care, improve health outcomes and reduce the costs of care for pulmonary diseases via AI-powered mobile health solutions.”

Schott AG, ARaymondlife and Vanrx Pharmasystems announce product compatibility for primary packaging of sterile injectables

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SCHOTT AG and ARaymond Life are announcing that SCHOTT adaptiQ® vials and ARaymondlife RayDyLyo® plastic press-fit closures are confirmed as a Product Set for use with Vanrx Pharmasystems’ Aseptic Filling Work-cells. This Product Set is fully commercially available and ready-to-use (RTU), with closure integrity performance results available from the suppliers.

The compatibility testing was part of the Matrix Alliance, an industry initiative of leading packaging and component suppliers, which aims at providing pre-validated container/closure solutions to work on Vanrx’s Aseptic Filling Workcells.

Using this Product Set, pharmaceutical companies have the assurance that the combination will function as a high-performance primary packaging system for sterile injectables. Companies can move drug products to market faster, by establishing flexible manufacturing operations using pre-sterilized, nested ready-to-use vials and press-fit closures with integrated stoppers in combination with Vanrx’s robotic aseptic filling systems.

A specific advantage of RayDyLyo® plastic press-fit caps is that they stopper and seal containers in one step, replacing aluminum crimp caps and eliminating their particle risk.

In selecting a Product Set, pharmaceutical companies receive assurance that all elements of the set, vials and caps, have been proven for compatibility and machinability with Vanrx aseptic filling systems.

As of this date, Product Set combinations are available in ISO standard 6R, and 10R vials, and corresponding 20mm press-fit closures. Contacts to request samples and performance specifications are listed below. These products are certified to work with Vanrx’s Microcell Vial Filler and SA25 Aseptic Filling Workcell.

Speaking on behalf of the three companies, Vanrx’s vice president of marketing Greg Speakman said:

“All three of our companies have seen how pharmaceutical companies are shifting toward building flexible manufacturing operations. SCHOTT, ARaymondlife and Vanrx are helping bring new products to market faster, benefiting the patient and our customers’ ability to respond to uncertain market conditions.”

The testing leading to this product set was completed as part of the Matrix Alliance, a collaboration between leading pharmaceutical packaging companies, of which Vanrx, SCHOTT, and ARaymondlife are members. The Alliance was created because next-generation drugs require high-ly aligned manufacturing processes and packaging solutions.

Aptar Pharma to Exhibit Innovative Drug Delivery Devices at Pharmapack 2018 in Paris, France

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Aptar Pharma, a leading drug delivery systems provider, will once again be a key exhibitor at Pharmapack 2018, Europe’s dedicated pharmaceutical packaging and drug delivery event, which takes place on February 7-8 at Paris Expo, Porte de Versailles, France.

 

Aptar Pharma’s booth, located at Hall 7.1, Booth B24/B26, will present their diverse portfolio of drug delivery solutions and will showcase their latest technology innovations. A dedicated connectivity hub will center on the field of connected healthcare solutions, a significant megatrend, which can greatly improve patient behavior and adherence.

Pharmapack provides invaluable insight into the latest trends, developments and regulatory changes impacting the industry, as well as a wide variety of learning opportunities. This year, three of Aptar Pharma’s experts have been selected to share their specialist knowledge during Pharmapack.

Gerallt Williams, Director – Scientific Affairs at Aptar Pharma, will present Opportunities and Challenges of Drug Delivery Via the Nasal Route, on February 8 at 10.00 am in Conference Room 741.  Dr. Williams’ talk is part of Conference Session 3: How will New Drug Delivery Solutions Revolutionize Patient Life and Improve Treatment Adherence?

Arnaud Fournier, Senior Business Project Manager – Injectables will present a Learning Lab on February 7 at 11.30 am at Booth H2.  His talk, Setting the Standard for Film Coated Stoppers with an Unrivalled Reduction in Particulates will discuss injectable drug trends given today’s stricter regulatory requirements. With more sensitive drugs being developed, Mr. Fournier will share insight into the need for tighter quality standards and coated packaging solutions such as Aptar Pharma’s PremiumCoat™ coated stopper, which offers an unrivalled reduction in particulates.

Sai Shankar, Director Business Development – Connected Devices, will present a Learning Lab entitled Driving Better Patient Outcomes with Connectivity on February 7 at 15.50 at Booth H2. Mr. Shankar will discuss how patient behavior can be changed through connective, intuitive, user-friendly devices, which can significantly increase does adherence and improve patient health outcomes. He will also feature Aptar Pharma’s connected device portfolio which covers Application Fields such as Respiratory and Eye Care.

Aptar Pharma will also be a selected exhibitor on Pharmapack’s guided Innovation Tours on Thursday, February 8, at 10.30am at the Innovation Gallery. The Innovation Tours take visitors on a tour of highlighted exhibitors who have made innovative strides in the industry.

Visit Aptar Pharma during Pharmapack at Hall 7.1, Booth B24/B26, where their team of experts look forward to welcoming their valued customers and partners from around the world and to exchange with key opinion leaders in the industry.

With over 400 exhibitors and more than 5,000 Pharma & drug delivery professionals expected to attend Pharmapack this year, Aptar Pharma welcomes the opportunity to once again be a part of this important industry event.

Tekni-Films discusses latest in rigid and flexible packaging materials for medical device, pharma applications at MD&M West

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The latest in rigid and flexible packaging materials for medical device and pharmaceutical applications will be featured by Tekni-Films, a Tekni-Plex business unit, at MD&M West, February 6-8, Anaheim Convention Center, Anaheim, Calif., in Booth 2027.

Tekni-Films will be discussing its TekniMD® PX copolyester film series with grades that provide a cost effective alternative to PETG for thermoformed medical tray packaging. The company also offers a laminated alternative to PVC for thermoformed pharmaceutical blister applications.

 

Tekni-Films also will be displaying its ultra-high barrier PVDC coating and a wide variety of other multilayer packaging structures that deliver the stringent oxygen and water vapor barrier properties necessary to protect pharmaceutical and medical device products.