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Three-piece can side seams ( a ) soldered; ( b ) cemented; ( c ) welded. Courtesy of Proceedings, 3rd International Tinplate Conference , 1984. 

Three-piece can side seams ( a ) soldered; ( b ) cemented; ( c ) welded. Courtesy of Proceedings, 3rd International Tinplate Conference , 1984. 

Contexts in source publication

Context 1
... the goal of these therapies is to maximize efficacy and protect patient safety, the most common way to classify devices is based on risk. Although the specific classifications and regulatory requirements vary from country to country, the intent is the same; risk-based classifications provide guidance regarding the appropriate level of manufacturing control and regulatory oversight required to ensure safe and effective products. GHTF, a voluntary group of representatives made up of regulators and industry, works to encourage convergence in the evolution of regulatory systems through the use of guidance documents that can be adopted globally. Because regulatory scrutiny frequently employs risk-based classifications, and classifications vary throughout the world, GHTF has tasked a group to catalyze harmonization of the classification system. On July 27, 2006 Study Group 1 (SG1) published its recommendations for device classification entitled ‘‘Principles of Medical Devices Classification’’ (6). This document is one of a series that, together, describe a global regulatory model for medical devices; although, at the time of writing, classification and other regulatory controls were yet to be harmonized. The GHTF classification system applies to all medical devices that are not used for the in vitro examination of specimens derived from the body, and it is based on risk. Risk is ‘‘a combination of the probability of occurrence of harm and the severity of that harm’’ (7). Device risk is a function of (a) the intended purpose of the device, (b) the effectiveness of risk management techniques applied during design, manufacturing, packaging and use, (c) the intended user, (d) mode of operation, and (e) the technology being employed (6). GHTF recommends a classification system based on four levels of risk (see Table 1), with the expected level of control increasing with increasing risk (see Figure 1). For detailed rules regarding how best to classify the devices, see ‘‘Principles of Medical Devices Classification GHTF/SG1.’’ As a general rule, packaging performs three broad func- tions—protection, utility, and communication—within three environments: the physical, ecospheric, and human (8). (See Packaging Design and Development for more detail.) Protection. Protection refers to protection of the medical device from the environment and vice versa. For medical device packaging, product protection is necessary to maintain package integrity throughout its entire life, including: sterilization, shipping, storage, handling, and use. Typical issues include protection from shock and vibration, crushing, puncturing, tearing, bursting, split- ting, pinholing, humidity, heat, and so on. The vital importance of maintenance of the sterile barrier system (SBS) is a distinctive characteristic of medical device packaging. Medical device packaging for disposables must not only maintain the SBS but, in many cases, also facilitate the sterilization of the device within. Such protective characteristics can be achieved through the package shape, particularly in thermoformed parts, in order to avoid product shifting or to keep kit components separated or nested. For sealed packages, seal integrity is an important characteristic in product protection. Seals must be free of channels and must withstand the rigors of sterilization and transit. Utility. Utility is related to the ease of use of the system. For many medical devices, quick and easy opening and removal of contents are crucial. While this consideration is also important for devices with relatively low risk, such as an adhesive bandage, it is extremely critical for sterile medical devices that are used in surgical arenas where the packaging must allow the device to be removed without contamination (aseptic presentation; see Figure 2). This particular need has led to the development of special materials and sealants that, when used in combination, can provide a package strengths that are adequate to endure the severity of processing and, at the same time, can be manually opened without imposing excessive stress on product or user. Package design plays a key role in the opening function. For example, for tray lids, the seal area should transmit the peeling force smoothly around the package. The shape of the seal and design and location of the peel tabs affect the relative ease of opening. Preferably, peeling tabs are located on the corners of rectangular trays. Lids should extend slightly over seal areas to avoid edge tear when peeled. Most designs are based on the classic ‘‘Chevron seal’’ or ‘‘corner peel’’ designs. There are some cases where the package may serve other functions such as a measuring device, dispenser, stabilizing stand, dis- posal receptacle, and other suitable applications (9). Communication. As with consumer goods packaging, secondary and primary medical device packages are a means to convey information through graphics, materials, and shape. Packaging communication operates at different levels, depending on the type of medical device. For over-the-counter (OTC) medical devices, such as condoms, glucose meters, adhesive bandages, thermometers, and so on, the communication role involves motivating a purchase, as well communicating important information for the safe and effective use of the medical device. Information may include directions, warnings, product benefits, brand differentiation, and so on. A very important aspect of package communication is product identification. This is especially true for devices that go into institutional settings, such as hospitals, where personnel may have to identify the correct device for a patient when seconds count. Increasingly, the manufacturers of medical devices must provide crucial information in several languages. The crowded labels can make the legibility, visibility, and accuracy of the information, all of which are important, challenging to achieve. Package manufacturers not only face these challenges when it comes to labeling their products, but must also be sure that inks (as well as other components of the package like adhesives) do not interfere with the product’s efficacy or safety. In the event that components of the packaging migrate, it is important that these unintended additives are nontoxic and do not degrade or affect the intended performance of the device. Selection of packaging style can impact package integrity. The type of package is largely driven by the characteristics of the device being packaged. These include size, shape, profile, irregularities, density, weight, and configuration (e.g., single unit or kit). For example, a high-profile, irregularly shaped device would be more securely packaged in a semirigid plastic tray than in a flexible pouch. As such, during the early design stages, it is critical to define the following ...
Context 2
... metal can is one of the oldest forms of packaging preserved food for long periods. In the same way, it has proven to be an adequate container for food stuffs, bev- erages, and industrial products. Thousands of different products of all kinds have been packed in metal cans. The traditional method of manufacture is to start with a rectangular sheet of tinplate or canstock that has special surface treatments. Blanks, or bodies, are cut from the sheets, flexed and rolled into a cylinder, and then notched and hooked so as to form a locked side seam, which results in a longitudinal joint line bonding both the lateral cut edges of the blank. Bodies are beaded for increased resistance against implosion of the can. More and more can bodies are necked to use ends of reduced diameters or/and thinner and more economical end stock, as well as to make cans stackable. Ends, i.e., the closures at the bottom and the top of the cylindrical or any other geometrical section of the can body, are tightly secured to the body by a double seam (called so because they are made in two operations). Both extremities of the can bodies are flanged so as to create the body hook, which engages with the end hook so as to form a tight, compact, and interlocked closure. One end, which is called the maker’s end, is fitted by the can manufacturer. The other, fitted by the filler or the packer upon filling the ‘‘open top’’ can, is known as the packer’s end. Because the container is made from three separate elements, it is known as a three-piece can. Its construction had remained basically unchanged for more than 150 years. Advances have been made in engineering, automa- tion, and speeding up of the original manual canmaking processes. The metal input has been gradually and con- stantly reduced through more sophisticated design geo- metry and more recently by changing the methods of making the side seam from tin/lead alloy soldering to welding (see Figure 1). Since the early 1970s, a different concept of canmaking has gained acceptance in commercial production. In this, the body and one of the ends, are formed in one entity from a flat circular blank by press forming technique (1). The open top end is sealed with the usual packer’s end. It is known as two-piece can. The methods of forming are identified: drawing and ironing (D&I in the United States, DWI in Europe) and draw and redraw (DRD) (2). D&I, for instance, was used in World War I for making shell cases. What distinguishes them in canmaking is the use of ultrathin metal in high-speed production to yield outputs counted in billions of cans per year. All processes convert flat sheet material into finished cans, which are supplied with a loose end for the packer or filler, according to this basic scheme: prepare plate matching the products to be packed, their filling and processing conditions as well as market conditions (climates, shelf lifes, presentation of cans, sanitary regulations, etc.); make bodies and ends; apply finishes (decorative or/and protective barriers). The order may vary, depending on the process used. The manufacture of three-piece and two-piece DRD cans starts with the finishing step. Some cans are resprayed with a top coat for increased corrosion resistance in a final stage of fabrication. Coils are usually cut into sheets or scrolled strips (technique Littell) if coil coated stock is used. Sheets are coated on one or both sides and are decorated if appropriate. The coatings are called enamels in the United States and lacquers in the United Kingdom. Decorations are always protected by over-or finishing varnishes to make them scratch proof and to add gloss. In case of processed cans, decorative or barrier coats have to resist the applied heat treatments in autoclaves. If the starting point is a circular blank, as for DRD cans or ends, then the cut edges of the sheets are scrolled for economy of metal usage (Figure 2). Alternatively, pre- coated coil stock may be fed directly into the cupping press for blanking and drawing or into the multi-die end stamping press. In the manufacture of two-piece D&I cans, plain coil, as supplied from the mill, is the starting ...


... Lockhart's utility function encompasses a diverse array of basic functions such as containment, and other added-value features, for example allowing aseptic presentation in medical device packaging. [23] Although some authors consider containment a separate function, we argue that containment is a utilitarian function not always present in packaging systems. In fact, there are many examples of packaging systems that do not contain a product, but rather hold or keep an item or several of them together (i.e., socks, scissors, tools). ...
Conference Paper
Full-text available
A heuristic evaluation is a type of inspection technique utilized to analyze and assess a product using a heuristic guide. It involves a small set of expert evaluators who examine the product and evaluate its compliance with recognized design principles (i.e., heuristics). Heuristic evaluations are a cost-efficient method to help identify problems before evaluations with users. A review of the literature reveals the lack of heuristic guides for new packaging development projects and the evaluation of existing packaged products. This study's objective was to fill this knowledge gap by developing a comprehensive heuristic guide that individuals could use, regardless of their level of packaging expertise. The study was divided into two phases: guide design and testing. The guide design phase involved identifying design characteristics of packages and refining their description to make them focused, easily understandable, and universally applicable. It required several iterations of refining and grouping. The second phase consisted of testing the heuristics with two panels of evaluators. The heuristic guide was converted into a 5-point Likert scale questionnaire. A group of ten packaging professionals with three levels of expertise (i.e., novice, intermediate, expert) used the evaluation guide to evaluate six packaged products. Qualitative feedback from the evaluators was used to improve the guide. Quantitative data from the questionnaire was used to determine if the evaluator's experience had an impact on the evaluations. A second round of testing was conducted using a panel of nine industry professionals and a new set of packaged products. Again, qualitative information was collected to improve the guide. The resulting heuristic guide has 50 design characteristics grouped into three main areas, one for each packaging function: protection (three sub-areas, 17 heuristics), utility (three sub-areas, 19 heuristics), and communication (four sub-areas, 14 heuristics). Results from the questionnaires did not show significant differences based on the level of evaluator expertise. Qualitative feedback allowed researchers to refine design characteristics and their wording. Industry professionals expressed interest in this innovative tool.
... However, often the pouches have been manufactured from laminated paper with polyolefin layers (Seavey, 2008). The choice of packaging depends, among other factors, on the type of sterilant (Billings, 2005) and each packaging must be developed, tested and monitored following a special procedure (Fuente and Bix, 2009). Typical single use packaging in hospitals include crepe paper, nonwoven fabric sheet, medical grade paper-plastic pouch, that are often sterilized either by steam, EtO or LTSF; and Tyvec  -plastic pouch, usually sterilized by hydrogen peroxide, since this process is not compatible with materials that contain cellulose. ...
Full-text available
Introduction Ozonization is an alternative sterilization process for heat-sensitive medical devices. However, the side effects of this process on packaging materials should be verified. Methods Four types of commercial disposable packaging for medical devices were evaluated after undergoing ozone sterilization: crepe paper sheet, non-woven fabric sheet (SMS), medical grade paper-plastic pouch and Tyvec©-plastic pouch. For each material, the gas penetration through the microbiological barrier was measured. Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were also evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy. Results All commercial disposable packaging showed good ozone penetration. Crepe paper and SMS were chemically and mechanically modified by ozone, while Tyvec© only suffered mechanical modification. Paper-plastic pouch was the packaging material which just experienced an acceptable reduction in tensile resistance, showing no variations on chemical or visual properties. Conclusion The results suggest that medical grade paper-plastic pouch is the most appropriate disposable medical device packaging to be sterilized by ozone when compared to other materials.