Selecting Optimal Pharmaceutical & Medical Packaging Systems
By Doug Slomski, Multivac, Inc.
For medical device manufacturers and pharmaceutical companies, choosing a packaging system is a strategic business investment that can ultimately help speed delivery times, improve product quality, and even provide new product innovations. Reaching these goals requires working closely with manufacturers to assess operation size, production process, automation possibilities, integration opportunities with manufacturing, verification requirements, and a careful analysis of how a product is used in the field. Also essential, is examining how technologies, such as modified atmospheres, can aid in irradiation sterilization of certain products. With all the right tools in place, a healthcare product manufacturer can leverage both a packaging system and package design to enhance product integrity while gaining a competitive edge in an industry where precision and efficiency is key.
Machine Features
Differentiating machines features is a vital first step in selecting a packaging system. A basic, but essential feature is stainless steel construction, which is beneficial for the highest clean-room and aseptic environments. Another key differentiator is the incorporation of measurement and control redundancies, alerting system operators of process parameters affecting uptime and aiding accurate process validation (IQ/OQ/PQ). Other widely used features are customized dies; computer process controls for diverse product lines and low-energy machine technology that assure sealing parameters.
Automated, high-speed systems are common for efficiently producing traditional packages, making them ideal for large-volume manufacturers. If using a large system, it is important to integrate upgradeable controls to guarantee seamless interface with up or down stream automation equipment within high-volume production lines. Often times these systems are supported by robotics to guarantee efficient productivity.
Moderate to small volume producers now have several choices for cost-effective packaging systems. The new generation of compact traysealers and rollstock systems have all the features of larger systems with the benefits of a smaller footprint and price tag. Smaller semi-automatic chamber machines are also practical alternatives or additions to a larger line for production of medical products such as orthopedic components and other supplies. Important features to look for on these units are standard lockout controls to keep temperature settings in place and glass-viewing windows for on-the-spot visual inspection of production.
Validation Essentials
Accurate validation systems ensure process repeatability and operating quality. They document problem-free validation of feature and option installation, operational parameters, and the entire packaging process. Promoting safe operation is vital to running a smooth operation and requires collaboration with a machine manufacturer that readily supplies documentation of extensive factory testing parameters such as software validation, factory acceptance testing, calibration of instruments, and certificates of accuracy for all machine features.
For instance, Multivac's three-part enhancement service allows medical device packagers to quickly and cost-effectively validate packaging machine operability through inclusion of a Factory Documentation Package, multiple Machine Features, Installation Qualification (IQ) as well as Operational Quality (OQ). In addition, remote management technology is incorporated and executed via the Internet, giving technical personnel outside the plant access to equipment for diagnosis and problem resolution.
Integration
Planning for expansion and integration is another important factor to consider when choosing machine options. Today's packaging equipment has been innovated to acquire data and conduct inline inspection. Manufacturers looking for flexibility in on-package labeling can go with a variety of options such as a cross-web labeler, mounted on top of a machine, a flexo or, thermal transfer or an inkjet system. Whatever the option under consideration, purchase should be done along side a medical focused packaging supplier to determine what best suits particular production needs, print quality, budget and regulatory requirements.
In fact, leveraging the supplier as a resource often creates opportunities for machine customization. A recent Multivac solution for header bag, breather bag and Tyvek pack customers improves package integrity while reducing supply chain costs. The automated thermoform, fill & seal Header Bag machine uses an exact amount of material, helping to extend proper package performance, reduce material usage and guaranteed product integrity through of the gas sterilization process. Multivac also meets the medical manufacturer's challenge of delivering precise, accurate sealing temperatures by incorporating TOSS control. These controls seal parameters at defined temperatures along with data verification that temperature dwell requirements have been met.
Package Design & Trends
Packaging designs should enhance performance and secure the integrity of pharmaceutical and medical products. Current designs span from pre-formed packaging to those customized to exact product specifications. Safety, ease of use, physical dimension, method of sterilization and compliance to regulations are also important considerations. Choosing an efficient package is accomplished through the expertise of a supplier's packaging engineers and consultants who focus on creating innovative, functional packages that ensure sterile end user integrity.
Effective and widely used types such as the individual-wrap package are used for single-use medical devices such as syringes or sponges and commonly supported by a thermoformed blister packs with easy-open or push-through dispensing capabilities. Products that need more protection such as, theatre kits, sutures, implants or surgical items are securely packaged in rigid multi-compartmental trays. New, innovative pouches have the ability to accommodate a variety of sizes. Tyvek material is frequently used for packaging wound dressings, gloves or catheters, where gas sterilization is used.
Water-soluble packaging, another convenient design that has been available for years, is just starting to become a pharmaceutical and medical packaging trend as it meets efficiency without compromising product integrity. The package is easy to use, provides a protective barrier and can be produced in a variety of shapes and sizes that quickly dissolve in water, eliminating the need for measuring and preventing spills. Products ranging from powdered drinks, nutritional supplements and children's medications are ideal for this application.
Service & Support Considerations
Choosing a machine supplier with medical packaging expertise, package design consultancy, intensive training courses and 24-hour responsive service will provide the utmost confidence and return on investment. For example, having a full team of service and support technicians focused on the medical industry, within a phone call, is not only good for current business, but ensures future success when industry needs change. Knowing this type of manpower is available when a system needs immediate service is a pivotal decision-making factor before purchasing, and essential for efficient production, product delivery and maximum uptime.
Additional questions to pose before system purchase are: 1. Does the supplier employ an efficient replacement ordering and parts delivery process to mitigate downtime? 2. Is the supplier's inventory readily available or is scheduled replacement necessary? These questions and more can be answered through access to a supplier's current customers, which is often the most telling of how a supplier works and interacts after the sale.
Protecting a Sterile Product
Often before a package design is chosen and supplier contracted, a modality of sterilization is selected, along with compatible materials. Fortunately, there are a host of new packaging processes and materials aimed at protecting medical products from physical as well as temperature-related damage. Many medical devices are sterilized with EtO gas, gamma or electron beam irradiation.
The MAP (modified atmosphere packaging) trend is growing and is most effective for irradiation sterilization where a package's atmosphere is infused with nitrogen to reduce the ionization effects on plastics. Moreover, MAP systems are implemented in any size production line for both thermo-form-fill-seal and traysealing machines, creating packages such as foil pouches or compartmentalized trays. These packages are often used for a variety of disposable plastic medical devices and made with standard film or foils.
Conclusion
Users of pharmaceuticals and medical products demand packaging that ensures product protection. This requires manufacturers to select a cost-effective packaging system and package design that assures product integrity, ensures sterility and is easy-to-use. Meeting all these goals requires partnering with a supplier every step of the way from recommending the optimal packaging system and package design to after-sale service, training and support. Confidence in this resource will ensure a customer-focused commitment to cost effective product delivery.