High protection levels against moisture, oxygen and heat are important for protecting active pharmaceutical ingredients (APIs), to provide the patient with an effective medication. Constantia Flexibles’ goal was to meet the very high barrier properties for pharma products, while implementing the best possible sustainability standards. The result is Perpetua, a recyclable product family, based on a unique line of full PP (Polypropylene) high barrier laminates. The flexible packaging solution is available in application-tailored versions. Being cyclos-HTP* certified, its recyclability ranges from 90% to 96%, depending on the individual material specification.

The high barrier properties and lower environmental footprint do not limit the design possibilities of the packaging.

The QuickVue® SARS Antigen test is a point-of-care rapid antigen test developed by Quidel® Corporation, a leading manufacturer of diagnostic healthcare solutions, that delivers test results in 10 minutes. The visually read test requires no supplemental instrumentation and offers expanded access to affordable and accurate COVID-19 testing that will help meet the urgent testing needs of the global economy, including for those in school systems and rural areas.

Aptar CSP Technologies’ Activ-Film™ technology is integrated into the diagnostic kit to protect against moisture and other environmental conditions that could otherwise impact test accuracy. Activ-Film™ leverages Aptar’s proprietary 3-Phase Activ-Polymer™ technology, which provides a broad spectrum of custom-engineered protection in a variety of configurations, such as Activ-Vial™ for housing diagnostics dipsticks and Activ-Tab integrated within diagnostic cassettes. This material science-based active packaging technology is currently used to protect a range of electrochemical, lateral flow and molecular diagnostic test kits on the market today.
“We are pleased to partner with Quidel® Corporation on this critical diagnostic tool and help bring the QuickVue® SARS Rapid Antigen test to the market,” said Stephan B. Tanda, Aptar President and CEO. “Our material science Activ-Film™ technology protects the test strips, helping to provide quick, reliable results. We will continue to live up to our purpose and responsibility to society by providing solutions that protect critical COVID-19 diagnostic kits, along with dispensing solutions for medicines and consumer products needed by millions of people each day.”

Badre Hammond, Vice President Commercial Operations, Aptar CSP Technologies concluded, “As we continue to navigate through the COVID-19 crisis, this game-changing solution will help meet the urgent demand for COVID-19 testing in communities around the world. We are committed to leveraging our material science expertise to enable our partners to meet the ongoing need for innovative healthcare solutions that help improve and save lives.”

High protection levels against moisture, oxygen and heat are important for protecting active pharmaceutical ingredients (APIs), to provide the patient with an effective medication. Constantia Flexibles’ goal was to meet the very high barrier properties for pharma products, while implementing the best possible sustainability standards. The result is Perpetua, a recyclable product family, based on a unique line of full PP (Polypropylene) high barrier laminates. The flexible packaging solution is available in application-tailored versions. Being cyclos-HTP certified, its recyclability ranges from 90% to 96%, depending on the individual material specification, the company says.

The high barrier properties and lower environmental footprint do not limit the design possibilities of the packaging.

Pierre-Henri Bruchon, EVP Pharma Division Constantia Flexibles, comments, “Our mission is to constantly rethink packaging to make a meaningful contribution to our customers and the environment. Sustainability plays a decisive role in all our business activities. Therefore, the development of a more sustainable but at the same time high-barrier solution for pharma products like Perpetua was of high importance to us. It is the perfect packaging solution for pharma products.”

Health authorities and regulators are increasingly looking for much higher levels of traceability during the manufacture of parenteral medicines. The most common processes and technologies applied to achieve compliance are now reaching their technical limitations – so new approaches are needed to deliver the traceability requirements. 

The International Society for Pharmaceutical Engineering (ISPE)  recently published the Discussion Paper, “Unique Identification on Primary Containers to Drive Produce Traceability & Quality”. It is the outcome of a  collaboration with a working group lead by the Stevanato Group, which includes pharmaceutical companies, contract manufacturing organizations (CMOs), fill & finish machine manufacturers, inspection machine producers, and a software company.

The document outlines the current implementation of unique container identification technology in parenteral manufacturing lines, including potential solutions, and a summary of the challenges technology developers face to develop and implement solutions within their operations.

Modern manufacturing operations in parenteral medicines are complex processes. Being able to trace each container within the process reduces risk and enables a detailed root cause analysis to improve each process.

Stevanato Group played a key role in drafting the document, leveraging its multi-year experience in the development of its novel container traceability solution that marks each primary container with a unique machine-readable 2D data matrix barcode. Each bulk or pre-sterilized glass syringe, cartridge, and vial aggregated in nested secondary packaging is given its own 'fingerprint'. Thanks to Stevanato Group’s high-speed visual inspection machines, marked filled containers with defects can be immediately identified and segregated. 
 

“Primary container serialization enables pharma companies to have unit-level traceability in the key steps of their manufacturing process, avoiding batch mix-ups before labeling and limiting batch segregation in the event of a problem, which often result in lost or missed revenue," says Fabio Bertacchini, Product Management Director at Stevanato Group.

"With this document, Stevanato Group is leveling the playing field of primary serialization to facilitate its implementation by the industry. As many of the existing technologies are closed due to IP ownership, our goal is to create an open-source solution that could benefit all. To do that, we are working with multiple stakeholders to remove any possible barriers to entry and implement solutions that minimize any impact on existing processes." says Tod Urquhart, Product Manager and Core Team Leader at Stevanato Group.

Demand for small batches of pharmaceuticals and medical devices has exploded in recent years, owing to a number of factors, including the rise of personalized medicines and orphan drugs and the industry need to produce small batches economically.  This has led to larger pharmaceutical manufacturers and CMOs (Contract Manufacturing Organisations) struggling to accommodate occasional low volumes on their high-speed production lines.

Sepha has introduced the new service in response to this challenge amid increasing calls for support from its larger pharmaceutical customers.

“Customers were looking to us for support with small runs. Some were having to halt 24/7 high speed blister lines to produce a few hundred sample packs. This is not what these lines were designed for and cannot be justified in terms of line clearance and changeover times. Sepha, on the other hand, is ideally placed to take on small runs, as we have all the know-how we have built up over the years with our laboratory-scale EZ Blister packaging projects, consisting of design, manufacture, process parameter optimization and analysis,” explains Paul Smith, Managing Director of Sepha.

He continues: “We believe we have something unique in the marketplace. We have a breadth of experience – spanning pharmaceutical packaging equipment, leak testing, deblistering and packaging design – that is unrivalled in the small volume contract packaging space. In the last 40 years we have partnered hundreds of pharmaceutical companies across the globe and have brought to market over a thousand different blister designs. This new service brings all these strands of our experience together in an exciting offer that will support our customers’ product quality, time to market and pack integrity ambitions.”

Sepha’s contract packaging division will operate from a new packaging facility in Belfast. Housing a range of dedicated blister packaging equipment, it will be able to accommodate the gamut of small-batch packaging projects, from cold-form and thermoform blisters to MAP packs, trays for medical devices, and temperature and humidity controlled packaging.

Sepha will also draw on over 30 years of design experience to offer a holistic blister packaging development service, complete with QA and non-destructive leak testing. Encompassing material selection, tooling design and 3D prototyping, the full-service offering will be particularly attractive to manufacturers looking to test or compare different materials and designs on a pilot scale.

The new contract packaging service is geared towards companies looking to outsource anything from 100 up to 10,000 packs per week, either as one-off runs or longer-term contracts. These might be packs for use in stability studies, multiple formats for patient compliance testing or marketing samples, for example. Multi-national pharmaceutical manufacturers wanting to focus on drug development and outsource the packaging of solid dose tablets, capsules and medical devices will be the main beneficiaries. Sepha is also keen to work with larger CMOs, for whom small or ad-hoc contracts are not always viable.

“We see ourselves working in partnership rather than in competition with large CMOs. We will nurture customers during the low volume, early life cycle stage, then, when a few hundred or thousand blisters becomes a few million, we will work closely with their chosen CMO to ensure a smooth transition into large scale production,” explains Smith.

Whilst the UK & Ireland and Western Europe will be Sepha’s primary target market, the service will be accessible to manufacturers and CMOs across the globe, thanks to strategic partnerships with specialist providers of temperature-controlled logistics with full track & trace.

However, for efficient filling of these often very dusty materials, good ventilation of the sack is required at the same time. How can these conflicting requirements of good venting and high sealing at the same time be combined? Complex venting systems, so-called labyrinth systems, are the answer. The POLYTEX as the universally applicable tube former from W&H is able to apply these complex venting systems.