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

plastibell

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

STIPLA

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

sanner

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.

Doppelherz sparkles with new packaging from Sanner

sanner

In the highly competitive market for food supplements, effervescent tablets in tubes are considered one of the most effective and reliable dosage forms. In contrast to other packaging types, tubes do not crack or bend. The tablets cannot crumble; they are protected from light and moisture and have a long shelf life. The dietary supplements producer Queisser also relies on these advantages for the successful Doppelherz vitamins and minerals. Since the beginning of last year, customers receive an even more consumer-friendly and attractive packaging thanks to the Sanner Brilliance® tubes.


Holistic concept from a single source

Queisser supplies customers in Europe, Russia and Asia with effervescent tablets. The company has been using the proven and tested desiccant closures from Sanner for more than 15 years. In 2016, they decided to switch to in-mold-labeling technology to achieve higher quality printing result and, above all, an improved readability for consumers. “With the Sanner Brilliance® tubes, we offer our customers a high-end product in high-quality packaging,” says Jürgen Hennings, Product Manager Marketing at Queisser Pharma. “The brilliant printing results increase the readability of the printed information, while providing a high quality impression and more attention at point-of-sale.”
But these were not the only requirements: Queisser also needed a different tube length for the Doppelherz effervescent tablets. “Sanner was the only supplier able to promptly produce the according tube length with IML technology,” Hennings explains. Instead of the conventional 144 millimeters, the Doppelherz tubes are 165 millimeters long. Sanner developed a new IML-capable tool specifically for the production of these tubes. “The combination of flexibility, quality and trust, together with the well-known desiccant closures were determining factors for our decision,” says Hennings. The company now receives a holistic effervescent packaging solution from a single source.


Flexible packaging with brilliant design

Compared to conventional tubes printed with offset technology, IML tubes offer higher-quality, photorealistic printing with different surface structures. Up to eight colors and real metallic effects are possible. The good readability of the label, even for smaller font sizes, provides more space for product information, while the impact- and scratch-resistant decor ensures long durability.
The packaging can also be upgraded with additional features: consumers receive more detailed information via QR codes with just one click, while peel-off labels can be used as an additional information booklet. This way, customers get an attractive packaging with all the information they require in a small space – and manufacturers can increase brand loyalty thanks to a high-quality appearance and exceptional user-friendliness.

Mérieux Développement and Gimv announce the signature of an exclusivity agreement with a view to acquiring Stiplastics Healthcaring

stiplastics

Mérieux Développement and Gimv, together with the management team, announce that they have signed an exclusivity agreement with Stage Capital, Stiplastics Healthcaring’s majority shareholder, with a view to acquiring the company.

Stiplastics Healthcaring, which was founded in 1985 and has been owned by Stage Capital (formerly NBGI) since 2013, designs, develops and manufactures standard and smart plastic solutions for the pharmaceutical industries and the health sector. Based in Saint-Marcellin (Isère – France), the company currently employs over 90 people on a 10,000 m2 industrial site opened last October. The Group expects to achieve turnover of EUR 21 million in the current 2017/2018 financial year, 98% of which will be generated by the health sector. Exports account for 55% of Stiplastics’ turnover, thanks to its development of devices for the dispensing of solid-form medications (especially in the USA).

Stiplastics Healthcaring has over 30 years’ experience in medical plastics. It works with customers throughout the entire process, from formulating the exact needs until the product is launched. It is a recognised specialist in the area of treatment observance, and its range of “intelligent” pill dispensers encourage treatment observance, and make administering and taking medicines easier and safer. It has also built solid expertise in solutions for respiratory diseases. Stiplastics Healthcaring works in partnership with pharmaceutical industry leaders and has recently developed an inhalation device.

The company has a strong development potential in the connected health sector, with new products in the pipeline and a modern workshop for the production of electronic products in a controlled environment. In order to meet the new needs of patients and healthcare actors faced with changing pathologies and uses, and more specifically the increasing prominence of connected care, the Group has set up its IoC [Internet Of Care]® unit, which is dedicated to designing, developing and producing e-health medical devices. In addition, several partnership agreements were finalised in 2017 in what is an extremely promising sector, which will benefit patients and practitioners alike.

Mérieux Développement and Gimv1 have joined forces to acquire Stiplastics Healthcaring. They will contribute their complementary expertise in the health sector and support the growth of this French company. Stiplastics Healthcaring will remain under the operational management of Jérôme Empereur and Laetitia Le Gall, who have successfully developed this high-performing industrial platform, whilst creating real sales momentum in recent years.

“The Mérieux Développement – Gimv consortium is an ideal tandem that will allow Stiplastics Healthcaring to grow further and accelerate its development. They bring to the table health sector specialists as well as substantial financial resources, which is perfectly suited to support the
Group’s growth challenges” explained Jérôme Empereur, Stiplastics Healthcaring’s Chairman-CEO. “Our decision to invest in Stiplastics Healthcaring is based on our assessment of the strength of the management team and our shared ambition on the company’s future. In particular, we have jointly identified the increased need for innovative solutions to improve observance and administration of medicines. We are delighted to be the new reference shareholder of this French company and to be given this opportunity to support its innovative strategy and international development plans.” says Jean-François Billet, Senior Partner at Mérieux Développement.

“Stiplastics Healthcaring has all the necessary assets to become a European market leader, including cutting-edge production facilities, excellent regulatory expertise and a deep understanding of its clients’ needs. We are very proud that Jérôme Empereur and the entire management team have chosen the Mérieux Développement-Gimv consortium to support them in their ambitious growth plans,” adds Benoit Chastaing, Partner Health & Care at Gimv.

The transaction is expected to close by the end of January 2018. No further financial details about this transaction will be disclosed.

Union Plastic presents its new innovative applicator cap APPLISIL® for vaginal cream

union-plastic

Union Plastic is specialized from the design to the manufacturing of medical device and pharmaceutical primary packaging.

Developed in partnership with laboratories and end-users for 6 months, the company launches during PHARMAPACK 2018 a new innovative applicator cap for its APPLISIL® range of product.

This new innovative cap improves traditional devices with its reinforced hygiene, security and ease of use.

 

 

The applicator cap APPLISIL® allows a 2 in 1 use: an adaptable side to the main vaginal cream tubes and a side suitable to the vaginal applicators APPLISIL® (dosage from 0.5 to 5 ml).
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This new product has a lot of advantages:

– Total absence of particle discharges (aluminum and/or plastic)
– Resealable stopper
– Adaptable to several aluminum tube diameters
– Reinforced hygiene
– Adaptable to the applicators APPLISIL®
– Tamper evident in option

The cap applicator APPLISIL® has got a patent registration and will be marketed from the second half-year 2018.