TPE compounds grow in importance as viable option for medical applications

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Recent regulatory and market drivers, including cost pressures, are generating a material choice debate about polyvinyl chloride (PVC), thermoplastic elastomer (TPE) and rubber materials, according to Colorite, a Tekni-Plex business unit specializing in custom medical-grade compounds.

Many companies are trying to proactively address new regulatory dynamics, both in the United States and in many other global regions. Pressure is being applied by healthcare systems that are already implementing strategic initiatives for phthalate-free patient environments. TPEs are being viewed as a replacement for PVC in applications where phthalate- or plasticizer-free materials are desired. Globally, IV therapy producers are among the first in the medical device industry to transition from PVC to TPE materials.

More recently TPEs also have been used to improve ergonomics, protection and/or function. TPEs are ideal for overmolding which provides a softer touch and improved ergonomics (such as grip) for a variety of surgical tools and devices. This can improve instrument control and fatigue reduction during long procedures for medical professionals.

Colorite’s Cellene® line of TPEs are suitable for a wide variety of uses in medical devices, packaging and other regulated markets. Cellene® compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.

Discover the last issue of Flexmag from Technoflex, a webmagazine dedicated to injectables

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After more than two centuries of improvements, injectable drugs have brought many advances to medical treatments. This progress has been achieved in collaboration between the medical, hospital, pharmaceutical and industrial sectors. One of the difficulties is that injectable molecules which are sensitive or unstable in a reconstituted medium, are recommended in many treatments. To make them easier to reconstitute and administer, our teams have designed and developed a double chamber bag which allows the main active ingredient in the form of a powder or lyophilizate and the associated diluent to be packaged together, thus facilitating the extemporaneous preparation of the infusion.

Link to Technoflex’s last webmagazine, Flexmag :

https://www.technoflex.net/en/flexmag/flexmag-12/ 

Almac Group Expands US Specialised Commercial Packaging Capabilities

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that it has expanded its US commercial packaging capabilities at its Audubon, PA facility.

Addressing increased client demand of developing and bringing more advanced medicines and niche orphan drugs to market, Almac Pharma Services has enhanced its offering by adding bespoke technology for the specialised packaging of complex kit assembly for medical devices, combination products and biologic packs.

The innovative semi-automated packaging system (SAPS) was tailor designed, built and installed by Almac’s in-house engineering team providing a best-in-class packaging solution for medical device kits and parenteral delivery forms.

The SAPS line provides a streamlined and efficient semi-automated process for the packaging of complex medical kit components and can process both standard and custom syringes, as well as auto-injector pens and any other medical devices. The highly customisable technology can operate to various scales, allowing for a variety of pack formats from sample kits to marketing packs in addition to multi-product dosage packaging.

Ensuring quality is guaranteed throughout the process, the specialised packaging line has multiple state of the art vision systems providing 100% automated verification and rejection of all components, ensuring variable data correctness, full colour recognition and medical kit completeness.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “Almac continues to invest in, and expand upon, our US commercial packaging capabilities. The introduction of this specialised technology not only enhances our existing US commercial labelling and packaging capabilities, but provides an efficient and cost effective semi-automated packaging solution to meet the evolving packaging needs of our client partners.”

Sanner CR packaging: maximum security, easy to handle

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Child-resistant (CR) packaging can help prevent unintended child poisoning and save lives. In the pharmaceutical industry, many drug producers do not want to wait for continent-wide or even worldwide regulations. Instead, they are already actively looking for suitable solutions. However, it is not always necessary to develop a completely new concept.

Small modification, large effect

Experienced suppliers like German closure specialist Sanner can help pharmaceutical companies optimize their existing packaging solutions with only a small modification. Sanner disposes of long-term market experience and has transparent production and quality management processes installed, which ensure regulatory compliance, as well as comprehensive documentation and reproducibility of the CR features.

Combination of strength and cognitive component

When developing CR packaging, two aspects should be taken into account – purely “mechanic”, that is force-related safety, as well as the cognitive component. On the one hand, a learning effect is required, for instance when a closure can only be opened through a certain sequence of movements. On the other hand, the force needed to open a package is just as important.

Apart from the push/turn version commonly used for large tablet containers in North America, there are numerous further possibilities to make primary plastic packaging child-resistant through a combination of movements, like the “press-in push-up®” mechanism of Sanner’s CR-FlipTop. This innovative packaging for tablets and capsules with an integrated desiccant mechanism combines maximum child safety with easy handling and a cap design that attracts attention at POS.

“As easy as possible, as difficult as needed”

This motto brings it to the point: CR packaging should be designed to protect children from unintentional ingestion of medication, yet at the same time it must ensure that patients have easy access to the content. Especially for senior citizens, easy handling of the opening and closing mechanism is paramount.

For instance, two pressure points that are incorporated into the closure enable grown-ups to easily open this self-explanatory packaging. Children, however, find it difficult, especially because the push movement is followed by a tipping movement. This way, relatively simple changes to a packaging can ensure additional safety. In the past years, Sanner has developed a number of solutions and introduced them to the market. They not only show how important child-resistant packaging is. They also prove that safety and user-friendliness can be combined without much effort.

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.