By Dividella AG,…
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Flexible configuration of modular packaging machinery
As regulation increases and fragmented markets require greater product quality and targeting, so the pharma industry requires ever more flexible configuration of modular packaging machinery.
The global pharmaceutical packaging market is projected to increase in value to almost $95 billion by 2021, having experienced average annual growth of almost 6.5% since 2015.*
However, this is not just a rapidly growing market but also a rapidly changing one, facing acute challenges in how it responds to ever-greater sophistication and complexity.
These are challenges that Dividella can meet with highly modular packaging lines that enable uniquely flexible configurations.
The need for flexible configuration in pharma packaging
As pharma/biopharma drug products become increasingly targeted and sophisticated and with increasing regulatory demands for tamper-proofing, track & trace marking and serialization, packaging needs are also changing rapidly.
Packaging equipment must address the specific challenges of product protection, patient ease and security, information and identification of products.
Furthermore, in an era of lean production and rapidly evolving market needs, the lines themselves must be increasingly flexible and adaptable to cope with smaller and more specific batches and rapid reconfiguration.
While capsules and tablets still account for the bulk of medicines, there is increased emphasis on other delivery methods such as prefilled vials, syringes, inhalation, and transdermal devices.
Self-administration of drugs or safety devices can require special assembly functions within the packaging process, along with the need to process oral dispersible films (ODF). This requires combining and converting packaging technologies into new configurations.
Equally significant, is the rise of personalized medicines, which now account for more than one in four New Drug Approvals (NDAs) and the FDA approving a record number in 2017. This growth, with consequent need for smaller batches has highlighted the need for packaging lines that are more flexible, modular and that can respond to shorter lead times.
Additionally, developments for compliance with anti-counterfeiting measures (e.g. The forthcoming EU Falsified Medicines Directive) adds complexity, resulting in the need for more tailored packaging solutions.
Finally, there is the data issue – the need to build serialization and unique tracking identities into every part of the process.
The ideal is to create holistic packaging solution that follow a multilateral approach to take in product, labeling and serialization in a combined and holistic process again; this requires a modular ability to reconfigure the basic building blocks of packaging lines.
The modular approach to flexible packaging lines
Modern pharmaceutical and biotech packaging equipment needs to fulfil multiple roles and objectives. It must be efficient in terms of throughput and total cost of ownership (TCO) while delivering minimum total cost of package (TCP). It should support the maximum choice of materials, particularly monomaterials to minimize volume, weight and use of plastics.
Perhaps most important of all, modern packaging lines need to be versatile and flexible supporting rapid and easy change-overs and reconfiguration to incorporate new specialized equipment to meet multiple applications as well as emerging drug delivery systems and data applications.
A further challenge is the growing need for automation and digitization, aligning data with the strict regulatory requirements of the pharmaceutical industry, such as process validation, serialization, track & trace and electronic batch records and signatures.
All these challenges are best addressed by adopting a modular approach to the design and engineering of packaging lines.
This involves providing systems that are composed of standardized discrete modules that are scalable, reusable and universally applicable across a range of solutions. These modules share well-defined interfaces that comply with recognized industry standards.
The result is a system that can be readily tailored to individual and specialized demands and applications by selecting appropriate modules to be used them in varying configurations and combinations.
The modular approach extends into feeding systems allowing tooling changeovers to be made very quickly, and sometimes with a few presses on a touchpad.
This modularity extends beyond hardware. Software modules can be used to extend control and monitoring of production into quality control, extending all the way along the logistics chain.
Flexible configuration of Dividella modular packaging machinery
For Dividella, the challenge is to provide the appropriate equipment and services to enable customers to achieve fastest time-to-market with highly flexible platforms. Dividella’s modular concepts are designed to deliver not only efficiencies and adaptability in the production process but also meet the demands of the end-user in overall packaging solutions.
NeoTOP – flexibility in configuration
Dividella’s NeoTOP range provides linear and fully scalable upgrade paths that extend from manual packaging of small batches through to fully automated high-speed production of parenteral and other products.
The NeoTOP concept embraces a modular design and assembly concept that delivers flexibility in configuring the package format through sharing of specialized infeeding and other modules that add any required capabilities. It can thus accommodate multiple pack arrangements and last-minute product changes.
The NeoTOP approach also allows wider choices of materials and adoption of advanced monomaterial packaging concepts that feed through to material costs, logistic efficiencies, serialization and compliance, all reducing TCP and TCO.
NeoTRAY – best of both worlds
NeoTRAY is a fully automatic packaging machine that is capable of handling monomaterials at full-scale automated production for more efficient and cost-saving packaging solutions.
Most packaging machines are proficient in either sensitive top-loading or faster side-loading, forcing producers to make choices and accept overall diminutions in efficiency.
The NeoTRAY combines the best of both worlds in one solution, combining Dividella’s patented top-loading technology that gently places products into open trays from above with rapid side-loading that can manage large volumes of a wide variety of parenterals. It allows moth methods to be combined within the same packaging process.
NeoTRAY is designed to deliver the full flexibility needed to comply with new regulations, varying package sizes ad formats, changes in the dosage form, etc. NeoTRAY can process all medical dosage forms common today – efficiently, reliably, and at high speeds.
Again, the modular form means NeoTRAY can easily be reconfigured to allow producers to meet any future challenges.
Pharma 4.0 compatible
In partnership with its Medipak Systems stablemates, Dividella is pioneering innovative solutions leveraged from Pharma 4.0 concepts of shared data and artificial intelligence, clustered around a vertically integrated Plug & Produce concept of a standardized data interface between the production control system, packaging machines and the packs themselves.
Plug and Produce paves the way for further advances such as:
- Smart Packaging: Incorporating data in the pack to optimize production efficiencies process and ultimately to secure and personalize the product
- Enterprise Manufacturing Intelligence (EMI): Translating real time production data into usable information to enhance productivity and quality
- Smart Devices: Enabling remote operation and system diagnosis to deliver higher quality and hugely simplify setup and maintenance
- Condition Monitoring & Predictive Analytics: Interpreting real time metadata to maximise production efficiencies