Dual-Mix®, the innovative solution for error-free reconstitution

technoflex

Drugs which are unstable in solution have, until today, been packaged in powder or lyophilizate form in glass bottles. They then need to be reconstituted at the patient’s bedside, or in the hospital pharmacy, in aseptic conditions. There are many errors and accidents linked to reconstitutions which pose a real risk for patients and healthcare personnel: errors with diluents, dosage errors, needle stick injuries*, contamination, etc. To reduce these risks, Technoflex has developed Dual-Mix®, an innovative primary packaging which meets three challenges: storing the drug to be reconstituted, making its reconstitution secure and ensuring the safety of healthcare staff and the patient.

Dual-Mix® is a patented bag which contains a medicine in powder/lyophilizate form and the associated diluent in the same dual-chamber primary packaging. It facilitates and makes safe the packaging of very unstable molecules which need to be reconstituted just before administration to the patient. Designed in Inerta® polypropylene, the material in contact with the main active ingredient and the diluent is fully compliant with European and American pharmacopoeias.

The bag is delivered sterile and consists of a lower chamber for the diluent and an upper chamber for the main active ingredient. The latter is the component which requires the highest protection. So, a peelable aluminium label, which can be placed on both sides of the bag, protects the powder or the lyophilizate from light and humidity. It is easy to remove at the time of use, and the nurse can very simply check the integrity of the product before its reconstitution.

The two chambers are separated by a peelable seal. It is sufficiently hard wearing not to break spontaneously during transport or storage, but is however easy to break by using simple appropriate pressure on the lower chamber to ensure that the main active ingredient and its diluent are mixed just before infusion. Reconstitution is achieved in under 10 seconds and in a totally safe way. The bag’s closed system ensures that the product is sterile and avoids risks of contamination during handling. Finally, Dual-Mix® has a twist-off compatible with the majority of spikes and infusion sets used in Europe and the United States.

Dual-Mix® is available in three different volumes of 50, 100 and 250ml and opens the way for standardized ready-to-use doses of drugs. By avoiding the need in some cases for preparation in the hospital pharmacy, Dual-Mix® optimizes preparation and administration by medical staff. A not inconsiderable advantage and a great advance, making reconstitution and administration simple, fast and totally safe in a hospital environment, but also during hospitalisation at home or in emergency or conflict zones.

* In the United States, 1000 people, 58% of whom are nurses, are affected every day by needle stick injuries, generating $1 billion in extra costs. (Source: Becker Hospital Review)

Sanner expands production in Hungary

Sanner

Sanner is consist-ently expanding its manufacturing activities in Hungary. By upgrading and optimizing the machinery park, the company is opening up capacities for new products and additional jobs. This is an important step in the integration and positioning of the Sanner group’s European production sites.

Sanner Hungária Kft is set for further growth: during the past months, the company has laid the technical foundations for an expansion of production by continually optimizing the existing capacities. Soon, further injection molding capacities will be available for new products. Sanner further plans to manufacture the desiccant cap-sules AdCap® at both sites in Bensheim and Budapest. Moreover, extending the automated, camera-based final inspection adds to an increase of efficiency in qual-ity management. “All these steps strengthen the position of the Hungarian site within the Sanner group,” explains Volker Pfitzenreiter, head of production Europe at Sanner.

Close integration of European locations

Sanner Hungária Kft was established in 1995 and has become the second, equally qualified European manufacturing site of the Sanner group. The GMP-compliant, SAP-controlled production is certified according to ISO 9001, ISO 15378 and BRC. The close integration with production at the headquarters in Bensheim with regard to technology, production planning and optimization processes pays off for the en-tire Sanner group: each year, a production volume of roughly five million Euros is realized in Hungary, two thirds of which are exported to other European countries.

Sanner_Hungaria_2

Teamwork is key to success
To ensure that customers always receive packaging solutions in the usual high Sanner quality, the team from Sanner Hungary not only relies on the good collaboration across production sites. In the own manufacturing facility, a close cooperation of the different divisions is just as important, for instance during the daily shopfloor management meeting. “A positive error culture and actively involv-ing the employees in the continuous optimization process is paramount,” Pfitzen-reiter says. “Only as a team can we achieve our growth goals and advance the location expansion in a positive working atmosphere. Due to the significant restruc-turing and optimization process, we are currently also looking for new colleagues, who want to become part of the Sanner team in Budapest.”

Sanner_Hungaria_3

Micro pump for Parkinson’s treatment from Gerresheimer subsidiary Sensile Medical receives European CE declaration of conformity

Gerre logo

A wearable micro pump from Sensile Medical has received EU certification for the European market. A European pharma company has obtained a CE declaration of conformity for the pump, which is specially designed for the treatment of Parkinson’s disease, and is now bringing it to market. This is the first time a micro pump from Gerresheimer subsidiary Sensile Medical has come into commercial use.

The micro pump is used in the treatment of advanced Parkinson’s disease. Its great benefit for patients relates to ease of use, including features such as automatic filling with liquid medicine. State-of-the-art technologies such as a color display, charging unit and data storage help enhance therapy management. The handy-sized, discreet pump comes with a leather bag for it to be worn on the user’s belt.

A prerequisite for market launch was the CE declaration of conformity for medical devices. Now it has that, the pharma company can bring the pump to market. Sensile Medical developed the micro pump for Parkinson’s disease treatment especially for the pharma company concerned. It is one of currently five concrete customer projects in various therapeutic areas.

“The CE declaration of conformity and market launch for the first micro pump, in this case for Parkinson’s treatment, marks a key milestone for our subsidiary Sensile Medical. The deservedly strict approval standards for patient-critical delivery systems of this kind are now satisfied and market launch can begin. We are correspondingly optimistic regarding further application areas for Sensile Medical’s micro pump technology,” explained Andreas Schütte, Member of the Management Board of Gerresheimer AG.

A personally programmable basal profile enables treatment to be optimized for Parkinson’s patients and ensures that they receive the precise dosage they need. Likewise for the bolus rate: A patient can cause the device to deliver a bolus at just one touch of a button. Sensile Medical’s patented SenseCore micro rotary piston pump at the heart of the pump device ensures exceptionally safe, precise drug delivery. An even greater level of safety is attained by eliminating flow rate calculations.

“In developing the micro pump for Parkinson’s treatment, we have completed a highly ambitious project to exacting requirements that improves treatment for patients. The device also comes with a large number of different languages already on board, enabling its use in many countries around the world,” explained Derek Brandt, CEO of Sensile Medical AG.

Aptar Pharma and Propeller Health Partner to Develop Digital Medicine Platform Across Therapeutic Areas

03

Aptar Pharma, a leading provider of innovative drug delivery systems, and Propeller Health, a leading digital therapeutics company, announced plans to collaborate on the launch of a comprehensive platform to develop digital medicines for multiple therapeutic areas and diseases.

The digital medicine platform, spanning inhaled, injectable, nasal and dermal medicine delivery forms, will combine software and experiences with connected drug delivery devices to more effectively treat diseases and improve clinical outcomes for patients.

Aptar Pharma and Propeller will work together with pharmaceutical and healthcare partners to accelerate the development, manufacturing and commercialization of digital medicines for leading marketed and pipeline brands. Digital medicines can help to personalize treatments, monitor patients in real-time, detect day-to-day changes in disease condition and increase patient adherence. Key objectives are to improve patient outcomes and help contribute to lower healthcare costs.

The collaboration brings together Aptar Pharma’s decades of expertise in device development, packaging innovation and quality manufacturing with Propeller’s platform and leading experience in digital therapeutics design and implementation.

The two companies initially partnered in 2016 to develop the world’s first fully-integrated
connected metered dose inhaler (cMDI).

Salim Haffar, President of Aptar Pharma, commented, “Aptar Pharma has been providingbinnovative drug delivery systems for nearly 50 years, helping billions of patients around the world. Today, we are excited to broaden our offerings as we continue this journey towards improved patient care and clinical outcomes by growing our partnership with Propeller Health, the leader in their field of digital therapeutics.”

“Propeller draws on nearly a decade of experience pioneering digital respiratory medicines and putting them to work in healthcare organizations around the world,” said David Van Sickle, cofounder and CEO of Propeller. “We’re excited to expand our relationship with Aptar and apply our expertise to new diseases. Our end-to-end infrastructure enables fast, flexible and secure development and commercialization of digital medicines.”

Propeller and Aptar Pharma will co-market the platform, with Propeller managing the digital services and Aptar Pharma managing the device development, manufacturing and supply chain.

In addition to expanding the partnership, Aptar Pharma has made a strategic equity investment of $10 million in Propeller Health during their latest funding round.

Tekni-Films introduces SBC 240 performance-oriented super-barrier coated thermoformable film for pharma blister packs

02

A new super barrier-coated (SBC) thermoformable film for pharmaceutical blister packs is being launched by Tekni-Films, a Tekni-Plex business.

Tekni-Films SBC 240 is being positioned as a performance and improved-cost alternative for 4- and 6-mil PCTFE and cold formed foil in thermoformable blister applications. The triplex structure is ideal for applications such as pharmaceuticals, nutraceuticals, probiotics and other related products.

In addition to its desirable clear properties, SBC 240 doesn’t require stiffening ribs, which can be used to improve the ability of PCTFE to lie flat, nor the oversized blister wells created by cold forming. This means that pharmaceutical companies can use a smaller blister card to contain the same number of tablets or capsules, or increase the count on a same-sized card. The end result is material cost savings all the way through the packaging process, including cartons and cases, as well as improved production efficiencies.

SBC 240 offers ultra-high moisture and oxygen barrier properties to protect products susceptible to degradation. It also has a wider processing window than PCTFE—as much as 20 degrees Fahrenheit—which helps meet specific production speed preferences.

SBC 240 is created by applying a “next generation” high-barrier variant of polyvinylidene chloride (PVdC) coating to a film structure made from layers of polyethylene. Multiple layers can be applied to create different coating thickness weights.  As coating weight increases, so do the barrier attributes.

This latest grade is just one more example of Tekni-Film’s robust SBC thermoformable film capabilities. The company also offers 120-, 150-, 180- and 210-gram coating thicknesses, as well as other custom solutions.

Almac Group Receives Recognition at The Irish Laboratory Awards with Laboratory Supplier of the Year Award

01

Almac Group, the global contract development and manufacturing organisation has announced it has won the Laboratory Supplier of the Year Award during this year’s Irish Laboratory Awards, presented by Business River. This award recognises BioClin Research Laboratories’, a Member of the Almac Group, commitment to delivering the highest quality analytical services to its customers and clients.

The Irish Laboratory Awards spotlight excellence and achievement in the laboratory environment, covering management, innovation, collaboration, personnel development and laboratory equipment supply. The winners were revealed at a ceremony on 19th April at Ballsbridge Hotel in Dublin. An independent panel of recognised and expert judges, representing Ireland’s scientific sector, determined the 2018 winners.

Judges awarded this based on the excellence demonstrated as a service provider, delivering “best in class” solutions to the pharmaceutical industry. Five additional companies were finalists for each category, as part of over a hundred nominees competing for twenty-two individual category awards.

Stephen Barr, President & Managing Director, Almac Sciences, commented: “I’m proud of our employees who work daily to provide unparalleled service to our customers and clients throughout the world. This award serves to highlight our team’s dedication and commitment to quality, and also showcases our diverse ability to deliver pharmaceutical, bio science and laboratory supplier services to the industry.”

Launched in 2013, The Irish Laboratory Awards has established itself as the premier event in Ireland for benchmarking those that demonstrate excellence, best practice and innovation in Ireland’s laboratories. These awards are an opportunity to showcase a company’s extensive knowledge, enthusiasm and expertise in the industry.

TPE compounds grow in importance as viable option for medical applications

03

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

06

 

 

 

 

 

 

 

 

 

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

01

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

03

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.