Abbott Laboratories (Abbott Park, IL)
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The Insulated Category A Shipping System by Saf-T-Pak Inc. (Edmonton, Canada).
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Protecting IVD kits during their distribution requires complex packaging decisions. Each of the components involved in keeping kits safe could easily justify entire textbooks unto itself. As such, the following introduction is meant to provide only a general overview of the important factors involved in IVD packaging decisions.
Before discussing the available components, it is worthwhile to look at the overall design process. The design of protective packages for test kits requires a team of engineers and scientists, as well as a group of marketing, quality, and regulatory representatives.
Where Does Package Design Begin?
During the design phase, IVD manufacturers must consider a number of questions. Although not all of these may require equal attention, each should be addressed to help ensure design quality.
• Will the kits be marketed stateside, overseas, or both? It is important to keep in mind that package design may change from clinical trials to market introduction.
• Have active components been finalized? A manufacturer’s development group should have chosen the final dosage format—liquid, lyophilized, tablet, powder, bead, or a combination of these.
• Will a sterile fill be required? As more-specific package components are considered, an answer to this simple question will help determine the primary container and closure materials.
• What type of primary container and closure system will be used? Plastic and glass bottles remain the containers of choice for IVD manufacturers. But manufacturers must also consider the variety of screw caps and liners, stoppers, aluminum seals, syringes, and other specialized components.
• What environmental conditions will the packaging experience? The issues of climate, both surrounding the end-user and encountered during product shipment, are numerous. Protection against light is the responsibility of both the primary and secondary packaging. Similarly, package design must take into consideration the intense heat and arctic cold that may be experienced during shipping and storage. For example, packing kits in dry ice remains the standard for global shipments. The –70°C temperatures endured during the trip require extensive testing to ensure that packaging is not damaged.
• Will hazardous materials be involved? The list of special packaging needs for shipping biohazardous, radioactive, corrosive, and flammable IVD products is extensive. If test kits contain hazardous components, specific labeling and markings must be used.
• What accessories will be required? IVD packaging often includes the plastic accessories required. These can include trays, plates, pipettes, dispensers, and tubes, as well as a multitude of stock and custom components.
• What other special packaging requirements are involved? Additional package needs range from basic desiccant canisters and pouches for protecting consumables from moisture to dunnage and bulk packaging material to prevent damage during shipment.
A Systems Approach
Testing and validation requirements will continue to increase, not decrease, in the future. The overriding concern of every IVD packaging group is to maintain both the safety and quality of the product. To achieve this goal, packaging experts must embrace the concept of integrated systems.
The development of packaging involves suppliers of raw materials, containers, closures, labels, and converters. Secondary package components include cartons, corrugated shipping containers, blister packs and trays, foils, and a multitude of polymer overwraps. In addition, distribution packaging requires pallets, strapping, and stretch wrap, as well as consulting and testing labs.
In a systems approach to packaging, these various components are grouped into a framework of common systems. The systems approach stresses an understanding of the complexities of a package and its individual components, but acknowledges that each of these lends value and quality to the final test. In the end, the packaging is critical to the success of any IVD test.
With IVD packaging, the package and the test it protects are an integrated and often indistinguishable unit. For example, it’s not practical to try to distinguish an aerosol product from the container that dispenses it. As such, it is often stated that product development and package development are done together on an interactive basis.
All IVD packages must protect, contain, and identify their tests. Together, these characteristics make up the building blocks with which a package system is developed.
Protection. Quality and protection are intertwined as the foundation of the IVD package. The package must be able to prevent harm to the product from such environmental threats as moisture or oxygen, as well as keep the product from inflicting harm on the environment or user.
Containment. The packaging of an IVD should be convenient to everyone who must handle and use the test. This convenience should extend not only to the final customer, but also to those who manufacture, transport, distribute, store, and ultimately sell the product.
Identification. Package labeling and product inserts are the means through which a manufacturer communicates with a consumer. To adhere to IVD rules and regulations, manufacturers must be willing to make continuous quality improvements to labeling components. For example, if a test contains hazardous materials, specific labeling and markings addressing these materials must be introduced. If products are marketed overseas, label requirements must again be revised.
What Next?
The choice of packaging components that complement the design of a test will greatly influence the final performance of the product.
Due to their seemingly unlimited potential as packaging materials, plastics remain the most widely used IVD component. When screening proposed materials, various characteristics must be weighed against cost and performance. For example, to what extent is sterilization required? If a thermoform is used, will a clear plastic tray help the end-user identify the medical product?
When reviewing plastic components, it is also common that many types of plastics will satisfy the basic package criteria. The relative economics of each material are often, but not always, a deciding factor in the final material selection. Consistent quality, regulatory restrictions, ease of resin processing, environmental disposal concerns, and the use of cost-effective sterilization also become factors.
Developing Component Specifications
A critical step between the development and market launch of a product is the creation of specifications. Product needs and process capabilities define what a purchasing group will specify and order. Specifications that are jointly developed by component supplier and end-user tend to perform better through the life cycle of a diagnostics kit and cause fewer quality issues and less stress.
Because the primary container and closure systems come into direct contact with the product and are subject to quality and regulatory requirements, they tend to be the focus of this process. However, secondary and tertiary (e.g., shelf and distribution) components also play an important role and must not be ignored.
As labels and other printed materials are critical during the life cycle of a test, these must be subjected to printed-commodity qualification and material structural evaluation. The labeling and cartoning of an individual IVD test or a complex kit are essential parts of the overall product design. Proper packaging and labeling ensure that diagnostic testing is efficiently distributed worldwide.
IVD manufacturers must also package their products to guard against vibration damage during truck, railroad, and airline shipment. IVD products can be accelerated and decelerated thousands of times a minute during their shipment to customers. Products encounter both repetitive and random shock sequences.
The Final Step
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The 2-8°C PCM System by Saf-T-Pak Inc.
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The final link in an IVD purchasing team is incoming quality assurance. The personnel who work in this area inspect and test samples of raw materials purchased from vendors to ensure their quality. Purchased packaging components that become part of a finished IVD kit have a direct effect on the quality of the production of that kit. To prevent the quality of tests from being compromised, components must be defect free.
However, material cannot be kept free of defects through the use of inspection and testing alone. The quality group must also rely on the team of suppliers to provide quality parts. The vendor must employ various techniques, beginning with statistical process control and in-process testing, to ensure that their materials meet high standards. To keep up with changing regulations, suppliers must always strive for quality improvement.
Vendor and supplier certification programs represent one method for recognizing those suppliers who have met all the quality requirements of a customer, often for a minimum of 12 months. A certification program enables manufacturers to forgo routine inspection and testing on incoming lots. Materials purchased from certified suppliers can safely bypass incoming inspections and be placed directly into the raw-material inventory.
Choosing Suppliers
Good suppliers share the same characteristics, no matter what product they produce. A supplier should be a technical and quality leader in its field, and therefore able to contribute technical expertise during the product design stage. In addition, a supplier should be willing to communicate effectively and openly, and be prepared to share its goals, commitments, and risks with a manufacturer in order to promote a long-term relationship. It should be knowledgeable about its own quality history and should be continuously seeking to improve. Finally, a supplier must be financially sound and shouldn’t change prices unexpectedly. It must deliver products on time, and should be able to do so with minimal supervision.
Certification. The process by which a supplier meets the certification requirements of an IVD company begins once a product’s characteristics have been established. Certificate criteria may include such things as an absence of product-related lot rejections for a specific period or over a specific number of lots.
Quality record. The supplier’s quality record must also be thoroughly considered. The quality of a supplier’s product has a direct effect on the quality of the final test kit. IVD manufacturers may wish to certify only those suppliers who have had no production- or customer-related negative incidents over a specific period.
Auditing. A packaging supplier should also successfully pass an on-site quality system evaluation audit. The audit is an opportunity for the quality engineering staff to examine and evaluate the following items in a supplier’s systems, procedures, and supporting documentation: organizational structure; material identification, storage, and control; handling of design and specification information; inspection procedures; quality assurance and manufacturing procedures; documentation of incoming material, in-process work, and finished goods; customer complaints; calibration of equipment; level of personnel training; equipment maintenance; and housekeeping and pest control.
Documentation. The supplier should fully document its process and quality system. At the quality levels appropriate for certification, all changes must be controlled. This is done to ensure that processes are accurately understood.
For a quality assurance system to be effective, it is essential that the product specifications and testing methods mentioned in this article be understood and agreed upon by supplier and customer. The supplier must be able and willing to furnish timely copies of certificates of analysis, inspection data, and test results.
The certification requirements for approved commodities will eventually result in certified suppliers that are subjected to little or no incoming testing before their packaging components are put into approved stock. It is imperative that the process that produces the commodity be nearly incapable of defect.
Justification. Only after all of these requirements are met should a supplier be certified. Even then, suppliers must still justify each component. There should never be blanket approvals.
In addition to improved product quality, numerous benefits result from a component certification program. The reduction in inventory for both supplier and customer results in cost savings and greater warehouse efficiencies. Certifications create fewer handling costs and free up critical time. They also help IVD manufacturers develop long-term business relationships and an enhanced ability to tackle problems as they arise.
Conclusion
Diagnostics manufacturers should never forget that IVD end-users are also suppliers. All the characteristics that manufacturers look for in a quality packaging component supplier are also valued by patients.
The successful design and development of a package has always required a team approach. While reviewing the following directory, remember the need for continuous quality, for suppliers with a partnership approach, and for a design team that always strives to produce the highest-quality products.
