Automated picking and packaging for highest demands
Packaging medical products is vital to protect them from environmental influences during transport and storage. The Medical Packaging Solution helps you to keep your products safe and intact until the moment they come into action.
What’s the struggle with the packaging of medical devices?
The packaging of medical devices and other products that require special protection for transport and storage is one of the final steps in the manufacturing process. It implies bringing together different products with different kinds of packaging – and here lies the challenge of this step.
Manufacturers need to be extremely flexible: Both the medical product and the type of secondary packaging change regularly.
MEDICAL PACKAGING SOLUTION
Automated protection with the Medical Packaging Solution
State-of-the-art camera technology
State-of-the-art camera technology
Our AI-supported camera recognition with optimized lighting technology recognizes your bulk material and automatically makes a completeness check.
ESSERT’s Medical Packaging Solution helps you to automate medical product packaging, despite the great variability of this process.
Nevertheless, flexibility is one of the platform’s major strengths, being easily adaptable to changes in secondary packaging or the products to be covered.
The Medical Packaging Solution based on our ADVANCED Robotic Workstation automates packaging processes with no compromise in flexibility and reliability. Especially in High Mix / Low Volume manufacturing, this comes with several advantages.
Consistent quality
Thanks to state-of-the-art camera and sensor technology, the Medical Packaging Solution can achieve consistently high quality.
Easily adaptable for varying products and packaging designs
Products and packaging systems in the medical industry are constantly changing. ESSERT provides you with a flexible packaging solution that can easily be adapted to varying packaging requirements.
High autonomy for reduced downtimes
Thanks to the high autonomy time of the Medical Packaging Solution, medical device manufacturers can significantly reduce down-times in supply chains.
Compliance with regulatory requirements
Compliance with requirements issued by regulatory authorities like the FDA or EMA is essential in healthcare packaging, facilitated by the cleanroom- GMP-conform design of the Medical Packaging Solution.
Reduced staff requirements
Automated packaging with ESSERT frees up valuable human resources for those tasks they are trained for and most effective at – tasks where their workforce is indispensable.
Lowered production costs
Implementing ESSERT solutions reduces the need for manual intervention, the likelihood of damages in secondary packaging, and potential inconsistencies and inaccuracies during the packaging process. As a result, this can lead to reduced costs for vendors, healthcare systems and end-users.
Clients
Real businesses, real results.
At Roche, we were looking for a modular, flexible solution for assembling different devices and found this solution in ESSERT´s automation platform. The collaboration with ESSERT was characterized by a high level of innovation and the willingness to adapt to the requirements of the pharmaceutical industry.
Philip Schneider
Drug Product Manufacturing Network Technology Lead at Roche
The robot workstation impresses with its flexibility, scalability and integration of state-of-the-art camera technologies.
Arno Schroff
Department manager for plant and site development at Vetter
Where automated packaging solutions play out their strengths
Automated packaging solutions demonstrate their powers in the packaging of a wide array of medical products used in various healthcare applications.
In High Mix / Low Volume (HMLV) manufacturing, these systems are instrumental in efficiently packaging products like personalized therapies, specialized pharmaceuticals, intricate medical instruments, diagnostic kits, and sterile surgical supplies.
These diverse medical items demand versatile packaging solutions that can adapt to their unique requirements while maintaining the utmost precision and quality, making automation an invaluable asset in the healthcare industry.
Medical product packaging plays a pivotal role in the life cycle of healthcare items, evolving from a protective shell to a life-saving necessity. Meeting the packaging needs of medical products is crucial to ensure their integrity and effectiveness.
Whether it is sterile barriers for surgical equipment or protective packaging for pharmaceuticals, these solutions contribute to product safety, shelf life extension, and most importantly, the well-being of patients.
Medical packaging – sterile or non-sterile?
In pharmaceutical packaging, the decision regarding sterile or non-sterile packaging depends on the specific product and its unique requirements.
Products such as surgical instruments, injectable medications, and IV solutions necessitate sterile packaging to prevent contamination by microorganisms. These items require an extended shelf life and must meet stringent safety standards.
Conversely, non-sterile packaging is suitable for pharmaceuticals like various over-the-counter drugs. Products like bandages or different diagnostic kits have less stringent shelf life requirements and are less sensitive to potential contamination.
Packaging types & materials
Various packaging types and materials are selected based on the specific needs of each product. Materials range from high-density polyethylene (HDPE) for durability to glass for sterility, and aluminum foil for moisture and light protection.
These choices are pivotal for ensuring product stability, safety, compliance with regulatory requirements. Types of packaging that are frequently used for medical devices and products include:
Sterile blister packs
Trays
Plastic bottles
Glass vials
Flexible pouches
Wrap packaging
Cartons
Validation testing and regulatory standards
Validation testing and adherence to stringent regulatory standards are imperative in medical product packaging. This involves rigorous test methods to ensure the integrity and sterility of the packaging.
For instance, sterilization processes are validated to confirm the elimination of microorganisms, a critical aspect in pharmaceutical and medical device packaging. Compliance with regulatory standards is vital to guarantee patient safety and product efficacy. For this purpose, several guidelines have been put into place, for instance
ISO 12469: ISO 12469 sets standards for microbiology safety cabinets, defining criteria to ensure their safety and hygiene, e.g. to avoid cross contamination.
ISO 11607: ISO 11607 is an international standard that specifically pertains to packaging for terminally sterilized medical devices. It provides guidance on materials, design, testing, and validation to ensure that medical device packaging maintains sterility and product integrity throughout its lifecycle.
Applications of automated medical product packaging in HMLV manufacturing
Automated medical product packaging finds versatile applications in High Mix / Low Volume (HMLV) manufacturing settings. It efficiently handles the packaging needs of diverse and changing product lines, ensuring precision and quality in the production of personalized therapies, pharmaceuticals, medical instruments, and diagnostic kits.
Appropriate packaging for valuable personalized therapies
Personalized therapies are tailored to individual patient needs, resulting in diverse product variations. Automated packaging systems are essential in this context, efficiently accommodating the specific packaging requirements of each patient's treatment. They ensure precision, consistency, and a rapid response to evolving therapy configurations.
As the trend toward personalized therapies continues to grow, automation in pharma becomes indispensable for meeting the high demands while maintaining high-quality standards and reducing the risk of errors in packaging.
Late stage customization
In late stage customization for medical products, the need for automated packaging arises from the demands of adapting to frequently changing product configurations in High Mix / Low Volume (HMLV) manufacturing.
Automated packaging systems offer a precise and flexible solution to efficiently handle this dynamic environment. They enable rapid adjustments, reduce the risk of errors, and maintain stringent quality control when customizing healthcare products.
Medical product packaging is especially demanding in High Mix / Low Volume environments, where production princesses are characterized by regular and profound alterations. While mass production has already adopted automated packaging systems, HMLV manufacturing still involves a great deal of manual labor – also in the packaging of medical products – due to a lack of versatile automated solutions.
ESSERT Robotics has taken on the challenge to create an automated packaging machine that is up to the multiple challenges in HMLV manufacturing, and has developed the Medical Packaging Solution as a specialized configuration of the ADVANCED Robotic Workstation. It automates the process of packaging medical devices and other products with a high level of flexibility and customizability, allowing you to quickly adapt cleanroom- and GMP-compliant packaging processes with no programming skills necessary.
This is possible thanks to ESSERT OS – an intuitive operating system that also brings transparency and control to your manufacturing processes. With a tablet as the interface between human and robot, you can easily monitor ongoing processes and access your data history – for maximum process safety and traceability.
Medical packaging standards often adhere to regulatory guidelines set by organizations like the FDA in the United States and the European Medicines Agency (EMA) in Europe. They encompass various quality and safety requirements to ensure the protection, sterility, and integrity of medical products.
What are the packaging options for medical devices?
Medical devices can be packaged in a variety of ways, including sterile blister packs, plastic clamshells, pouches, trays, and more. The choice of packaging depends on the specific device and its requirements.
What is the ISO standard for medical device packaging?
ISO 11607 is the internationally recognized standard for medical device packaging. It provides guidance on materials, design, validation, and testing to ensure the integrity and sterility of medical device packaging.
What is the packaging for sterile medical devices?
Packaging for sterile medical devices typically includes sterile barrier systems, such as pouches, trays, or blister packs, designed to maintain sterility throughout storage and transportation.
How are medical supplies packaged?
Medical supplies are packaged using a range of materials and methods. Sterile items are often sealed in pouches or containers that maintain their sterility, while non-sterile supplies may be packaged in various forms, including plastic bags, bottles, or cartons.
What is ASTM in packaging?
ASTM International is a standards organization that develops and publishes industry standards, including those related to packaging. These standards ensure the quality, safety, and performance of packaging materials and products across various industries, including healthcare.
What are packaging materials for medical products?
In addition to ethylene oxide sterilized materials like polypropylene and thermoforming options, glass and aluminum are also commonly used materials for packaging medical products.
Glass is favored for its inert nature, making it suitable for storing injectable medications, while aluminum is chosen for its barrier properties, protecting sensitive medical products from moisture and light. The choice of packaging material depends on the specific requirements of the medical product and the need for protection, sterility, and durability.
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