Incorporating Alternative Medical Packaging Processes
By Doug Slomski, Director – Medical Division, Multivac Inc.
Since Tyvek® has long been regarded as the best material to preserve the reliability of medical products, lower-cost alternatives have attempted to strike a balance between sterility and cost efficiency. As a result packaging technology has evolved to require only a minimal amount of Tyvek to promote breathability. A profitable, cutting edge business practice extends both these goals by bringing the entire medical packaging process in-house to create packages meeting industry standards. This can also result in saving overall supply chain costs, including production time and labor. The good news is that nearly every product currently packaged with a significant amount of Tyvek is a candidate for this type of packaging system.
In-house Processing Benefits
Choosing an in-house Tyvek packaging system as part of a strategic business investment outweighs external packaging fulfillment by eliminating costly converting operations. This enables the buying of raw material versus finished product, and provides flexibility to package a diverse product line. High-productivity medical and pharmaceutical processors making an initial investment in a customized thermoform-fill-seal packaging solution can incorporate packages with an appropriate amount of Tyvek that ensures products such as surgical kits, rigid packs and flexible packs consistently meet specific safety guidelines, barrier and sterility requirements.
Getting the greatest investment return is easily met by working with an experienced medical packaging supplier who has the right Tyvek packaging technology to reduce material needs, transport and storage costs, in-turn bringing costs benefits to the end user. On the other hand, continuing to purchase expensive pre-made header bags attributes to higher business carrying costs, offers less flexibility, and requires more packaging manpower -- driving up prices to customers who might eventually look elsewhere to find more cost-effective solutions. In addition, pre-sized packages do not guarantee product integrity, as they are rarely able to accommodate exact product specifications, increasing the risk of reduced product dependability.
The choice to insource vs. outsource often depends on what type of products manufacturers are producing, packaging size, budget, and facility-space. However, as medical product manufacturers continue to expand their market presence with a variety of innovative products, the more rewarding an in-house packaging process becomes to their business and customers.
Customized Packaging Solutions
New customized packaging designs have been innovated to promote the characteristics of the porous Tyvek material, by substituting its majority with validated paper or films to perform as the microbial barrier. Equally as important is accurately leveraging a supplier's specialized medical packaging team to successfully incorporate a customized Header Bag or Breather Bag solution that extends flexibility and the performance of medical products.
For example, Multivac has taken Tyvek technology a step further by creating advanced, automated Header Bag and Breather Bag thermoform-fill-seal rollstock solutions that are customized to the needs of high-volume manufacturers. And by incorporating this technology in-house, manufacturers can reduce costs, maximize return on investment and deliver high quality medical products. Either option extends sterility benefits and deciding on which system to go with depends on the product size and depth of package needed for a proper form and fit.
The Header Bag option provides a customized thermoform-fill-seal machine with a flexible bottom web and two sealing webs. The first web is used to cover the majority of the bag, while the smaller web seals the Tyvek anywhere on the package. Manufacturers using this system are able to effectively meet any standard dimension, further reducing Tyvek costs and promoting the efficacy of gas sterilization.
Those processors requiring Breather Bag packaging features can achieve sterility and breathability, while reducing costs with an innovative solution that constructs a bag or pouch from polypropylene sheets. Within the package a heat-sealed Tyvek breather patch is placed to form a breathable surface area for items such as tubing, catheters, dialysis aids, and implant material.
Optimal Sterility
Use of Tyvek enhancing materials significantly improves the sterilization efficacy of a variety of medical device applications, including standard operating procedural kits and other procedure specific medical tools. High-volume medical product producers are finding that customized Tyvek packaging helps guarantee optimal sterilization and gas flushing benefits when compared with using standard, pre-ordered Tyvek packages that are costly, take up more air space without guaranteeing delivery of optimized product integrity. Additionally, utilizing a cost-effective Tyvek-compatible packaging solution prevents contamination of bio burdens.
The advantage of implementing an in-house thermoform-fill-seal solution comes with the reduction of a vacuum package's footprint to the exact amount of Tyvek material required to optimally protect product integrity with a tight fit. This is important since many manufacturers are purchasing packaging solutions that accommodate a wide array of products and need to promote the presence of product integrity across various large-volume products, while employing a cost conscious system to ensure their market leadership.
Added Features & Benefits
Regardless of what type of packages manufacturers needs, packaging suppliers should be relied upon to recommend an optimal system that includes special heat-sealing devices that secures the film to the Tyvek before it reaches the sealing die. And for healthcare manufacturers adhering to labeling parameters, an experienced medical packaging supplier will suggest whether to use preprinted film, or films printed with Thermal Transfer, Flexographic, or an Ink Jet printer. Also significant is the availability of Factory Acceptance Testing, Installation, Installation Qualification, and training. And, suppliers who stock an ample supply of replacement parts helps manufacturers maintain maximum uptime.
Suppliers having remote management technology available can help manufacturers incorporate diagnosis and problem resolution via the Internet, giving technical personnel outside the plant access to potential situations that might affect machinery uptime. Moreover, specialized medical packaging expertise ensures systems are error free, provide validation requirements and reduces the costs of doing business throughout every stage of the process.
Conclusion
High-volume medical manufacturers now have a choice on how to best enhance the use of Tyvek on packages for maximum sterility, new product innovations and business cost savings. More and more medical product companies are deciding to extend their market investment with an inline packaging solution that compliments and completes their production process. Incorporating this process significantly reduces Tyvek packaging and material costs, while promoting optimal sterilization and product integrity that results in companies meeting product goals.