Originally Published IVD Technology October 2005
Packaging and labeling materials and components
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| Adhesives Research Inc. (Glen Rock, PA) manufactures a variety of custom adhesive tapes, coatings, and laminations using acrylic, rubber, silicone, conductive, hydrophilic, low-fluorescence, and high-MVTR technologies. |
All the work that goes into developing an IVD test is useless if the test reaches customers damaged. IVDs must be prepared properly for storage, transportation, distribution, and use, and their packaging plays a key role in containing, protecting, preserving, and transporting these important products.
Package testing should be an integral part of the development of an IVD device. As such, it can address design issues that could compromise the quality of the finished product. Testing performed in advance of the first actual commercial shipment can ensure that the package design will provide adequate protection for the IVD. For this shipping testing, packaged prototype IVD products can be used.
Once this testing has uncovered potential problems with product handling and distribution, the manufacturer can make necessary modifications to the package design and materials. The company can then conduct subsequent tests to confirm that these modifications are successful.
Following is a discussion of some IVD-package design considerations and test methods for verifying that the design works as intended.
Package Design
The chief design considerations for an IVD device package include choice of materials, temperature control, use factors, manufacturability, and cost.
Packaging Materials. When selecting packaging materials, a manufacturer must take into account the size and weight of the final package. Typically, designers should select stronger materials for larger packages and for packaging that will be used to transport relatively heavy weights. They should choose weaker—that is, lighter-weight—materials for smaller IVD packages whose contents weigh little, as this will lower the overall packaging cost.
Product-contacting packaging materials must be compatible with the IVD test within the package. Stability studies may be conducted to prove that the packaging material does not react with the product it touches. Even the secondary packaging material, which does not come into contact with the product, should not react adversely with the package contents when dangerous goods are being transported. This is especially important in the event of leakage from the primary container.
Temperature Exposure. Another design consideration is the temperatures to which the package might be exposed during shipment. An IVD test’s storage conditions must be maintained during transport, unless the manufacturer has test data that show that temperature excursions are acceptable. Most biological-product IVD tests require temperature control during shipment.
Insulated shippers, in combination with such refrigerants as dry ice, gel packs, and phase-change materials, are used to control the environment of temperature-sensitive IVDs in transport. The shipping-temperature ranges most commonly specified for IVDs are 15°–30°C, 2°–8°C, under 30°C, and –20°C or colder. Shipper-and-refrigerant combinations can be qualified to ensure that they maintain package contents within a given temperature range for some number of hours, for example, 24, 48, 72, or 96 hours in transit. In such cases, the transit time of each shipment must be monitored to make sure that it falls within the qualification limits. Year-round real-world testing of packages with temperature monitors inside might be conducted to identify the temperature levels and temperature-change profiles that IVD tests would have experienced during shipment. Then, temperature profiles based on these real-world testing data could be programmed into environmental chambers, simulating in the laboratory the temperature stresses a shipped IVD could encounter.
Often, two temperature-test profiles are used for the qualifications, one for summer conditions and one for winter. It is common, therefore, for at least two configurations of refrigerant to be included in the insulated shipper undergoing simulation testing. The insulated shipper–refrigerant package is then subjected to simulated summer and winter temperature profiles. If the temperature of the product remains within the required temperature range for the specified time, the combination package is qualified.
Unqualified combination packages are often shipped with a temperature recorder enclosed. The device is read by the recipient to confirm that the IVD remained within a proper temperature range during shipment. Labels that change color when exposed to different temperatures also can be used to confirm temperature control. Another alternative, for bulk shipments, is the use of refrigerated trailers and refrigerated containers for oceangoing freighters.
Human Factors. Designers of packaging for IVDs also should consider human factors—that is, user requirements. The packaging should be easy to use. It should be able to be opened without tools or excessive force. Additionally, if the IVD requires dispensing or measuring, then its packaging should facilitate this task. Tamperproof packaging or tamperproof labeling might also be necessary in some cases, for safety or security reasons.
Manufacturability. An IVD’s manufacturability should extend to the package design. Ideally, IVD packaging should be easily accommodated by the manufacturing process. Packages having uncommon or unique shapes should be avoided, if possible, because they necessitate custom-made production equipment, which is often more expensive and less reliable than standard off-the-shelf machinery designed for standard packaging shapes. Indeed, existing packaging elements might advisedly be retrofitted to standard equipment to improve their manipulability during such IVD manufacturing processes as conveying, filling, packing, and labeling.
Cost. Packaging design involves cost constraints. The IVD manufacturer should gain an understanding of all packaging-related factors in order to identify the factors that can be controlled or influenced to keep the overall packaging cost low.
The manufacturer might be able to control cost at the supply point. Whenever possible, purchasing volume should be used to leverage pricing. For instance, the packaging supply needs of several manufacturing facilities could be combined. Pooling orders allows greater amounts of packaging supplies to be purchased at lower cost. Standardizing package sizes and materials can also help save money.
Another idea for reducing packaging cost—one that is frequently used—is to purchase generic packaging that carries no product-specific marking and to label it when the IVD and package are manufactured. For example, instead of purchasing cartons already printed with product-specific information in multiple part numbers, each of them in low quantity, the manufacturer could purchase large quantities of generic cartons in a few sizes and label or imprint them in the factory with product information as they are used.
Environmental Friendliness. Package disposal is another design consideration. Packaging should not cause ecological harm. It should be reduced as much as possible, should be either recyclable or returnable, and must comply with the environmental regulations of the states or countries into which the IVD tests are shipped.
Finally, packaging problems and complaints should be collected, charted, and analyzed, and corrective actions taken. All changes made to the package in response to problems or complaints should be tested before the corrections become a part of the production process.
Package Testing
In most cases, package testing is conducted to ensure that IVDs can withstand the normal hazards and stresses of shipping. Typically, once the testing regime is completed, the IVD package must be found to exhibit no leakage, and its integrity must not have been affected.
Real-World and Simulated Testing. Although field data recorders can help gauge the shipping-related stress a package might experience in a particular distribution cycle, such real-world testing can be unreliable. Since stress levels can vary from shipment to shipment, simulated shipping testing based on real-world environmental profiles is the test method of choice. Laboratory-conducted tests can simulate a specifically characterized distribution cycle.
A test plan and an assurance level are selected from established test methods for use in each distribution simulation. Typically, for prototype design testing, stress levels above those normally experienced during actual shipment and storage are referenced. Levels more representative of conditions likely to be encountered in actual distribution are used for qualification testing. Simulation testing is performed in accordance with several industry test standards, including those of the American Society for Testing and Materials (ASTM), International Safe Transit Association (ISTA), International Organization for Standardization (ISO), and National Motor Freight Classification (NMFC).
Manufacturers—or the testing service providers they hire—undertake tests to determine whether a package is strong enough to withstand manual handling (e.g., loading, unloading, stacking, sorting, palletizing), mechanical handling (e.g., by pallet jack or forklift), warehouse stacking, vehicle stacking, vehicle vibration, and environmental hazards. This last category includes tests that assess a package’s ability to endure dropping, impact, compression, vibration, repetitive shock, temperature, humidity, and vacuum, for water absorption, and for stack stability.
Bottle and Cap Testing. The bottle-and-cap combinations commonly used for packaging IVDs should also undergo preproduction tests. Since torque degrades with time, temperature, vibration, and shock stress, torque guard-band studies should be conducted to determine what torque range to qualify, and extended leak testing should be undertaken to support the qualification of each bottle-and-cap combination. To minimize the amount of testing conducted, a manufacturer may wish to test only the worst cases or representative package families. Color is irrelevant to package performance in many instances. In such cases, testing one of the colors and extending the test results to all other colors generally is acceptable. Testing the largest of similar designs and approving the smaller designs without additional testing also is generally acceptable, as long as the same packaging material is used for all designs.
Hazardous Materials. The minimum performance testing required for IVD packaging that will contain material hazardous for transportation is based on several regulatory standards. These are the U.S. Department of Transportation rules in Title 49 of the Code of Federal Regulations, the United Nations Recommendations on the Transport of Dangerous Goods—Model Regulations (known as the UN Orange Book), the International Maritime Dangerous Goods Code, the Technical Instructions for the Safe Transport of Dangerous Goods by Air of the International Civil Aviation Organization, and the International Air Transport Association Dangerous Goods Regulations.
The primary packaging, secondary packaging, and outer packaging used for shipment of dangerous goods each must meet regulatorily prescribed performance requirements. For example, in packages designed to transport a product containing an infectious substance, both primary and secondary packaging must be watertight. Packaging at these levels must withstand, without leakage, a minimum pressure differential of 95 KPa and temperatures ranging between –40° and 55°C. The outer packaging must exhibit at least a minimum stacking strength and water-absorption capability. Additionally, the total package must include enough absorbent material to suck up the entire contents in the event of spillage.
Labeling
Labels for IVD packages also require careful design, manufacturing, and verification.
Material selection is one important element of label design. The label material, coating, and glue should be appropriate to the package. An application may require unique label materials and coatings to withstand particular storage, transportation, and use. For example, a label may need to withstand extreme storage temperatures, which can be higher than 40°C or colder than –20°C. It may have to tolerate friction from rubbing against other materials during transport, or temperature cycling between freezer or cooler and an ordinary room during use.
The printer used to mark the part number, lot number, and expiration date on the label during production—thermal transfer, hot-stamp, laser marker, or laser ink-jet—should also be a consideration in the selection of label material and coating. Once the label material is selected, the designer can then choose an ink—water, resin, or wax based—that will produce permanent, high-quality imprints. Finally, it is important to select a glue that will adhere properly to the plastic, glass, fiberboard, laminate, or other material that is to be labeled.
Abrasion performance, too, is an important consideration. Label abrasion can occur when the vibration experienced during shipment causes cartons and labels to rub surfaces. Ink scuffing due to abrasion can be mitigated or eliminated by adding a coating of varnish, lacquer, or ultraviolet-resistant or other such material to the label. A standard method for determining the abrasion resistance of printed materials is the Sutherland rub test.
It is advisable for the packaging and labeling selected for an IVD product to be easy to process during manufacturing. For example, if multiple panels of a carton have to be labeled, then it is best for all of these panels to be on the same side of the carton in its knocked-down state to allow for simultaneous labeling. To avoid the need for custom-made printers and label applicators, which can be more expensive and less reliable than standard off-the-shelf printers and labelers, unusual-shaped packaging should be avoided.
Existing packaging can be retrofitted for improved label processing. For instance, the glued end tab of a carton can be moved to another panel in order to have all of the labeled panels on the same side when the carton is knocked down flat.
Finally, it is advisable to use more than one printer in a manufacturing line in order to prevent production downtime during printer preventive and corrective maintenance. A second printer provides the ability to set up the next printing run and obtain the necessary line clearances while the first printer is still in a production run. In addition, it allows a single long printing job or different jobs to be run in parallel.
Alexis Carrion, Abbott Diagnostics (Abbott Park, IL)
Copyright ©2005 IVD Technology
