Device package

Stress of Materials. Low stress materials are essential for dedicated device packaging. To achieve this property a low modulus material with a thermal coefficient of expansion (TCE) match is required. The stress is mainly a result of the following equation ... 

Sec. 820.130 Device packaging - Packaging must provide adequate protection of the device Figure 11.15 Headings of the Quality System Regulations (QSR) from 21 CFR Part 820. 

Device, package, electronics and the assembly and packaging technology constitute the core components of the MST product. These rely heavily on the advances in materials science and technology. 

Pricing as well as reliability considerations have led to an almost exclusive use of Si-based (i.e. Si and SOI) micro machined devices. Packaging and assembly has focused on ceramics (A1203, AIN, Low Temperature Co-fired Ceramics LTCC), Printed Circuit Board (PCB-) and Surface Mount Device (SMD-) technology and multichip modules (MCM s). 

Approved packaging is normally selected after completing package performance qualification testing as well as product compatibility and stability studies. Since in most cases (exceptions transdermal delivery systems, diagnostic tests, and medical devices) packaging is not intimately involved in the manufacturing process of the product itself, it differs from other factors, such as raw materials. 

When the development and validation of the packaging manufacturing process are completed, the standard testing procedures (e.g., ASTM) should be used to ensure sterile medical device package integrity and the sterility of the product after additional production processes. 

The relationship between accelerated aging and real-time aging for packages has not been determined, and although the theory states that for every 10°C rise in temperature the reaction rate of material doubles, this should be applied with some caution for such materials as medical devices packaging. 

The overall protocol for packaging validation remains the same whether microbial challenge test methods or physical test methods are used. At each stage in the development and production process of a package for a medical device package integrity must be verified. 

O Brien, J. D. (1990), Medical Device Packaging Handbook, Marcel Dekker, New York. 

Schematic Symbols, Device Packages, Design and Testing...

Effect of Room-Temperature-Vulcanized Silicone Cure in Device Packaging... 

Biopolymers Lanthan, dextran, polyhydroxybutyrate Food additives, medical devices, packaging... 

Other medication errors involving medicationdispensing devices reported to the USP have included the interchange of devices supplied with specific products. Each device packaged with a medication is calibrated for that medication based on the viscosity and concentration of the specific liquid it delivers. These devices are not calibrated in any standardized way some are measured in milligrams (mg), others in... 

Kim-Kang, H. Gilbert, S.G. Permeation characteristics of and extractables from gamma-irradiated and non-irradiated plastic laminates for a unit dosage injection device. Packag. Technol. Sci. 1991, 4, 35-48. 

The largest stresses are observed as shear stresses at the corners of the die at the lowest temperature. Three commercially available epoxy-based molding compounds were studied. Two of these materials are standard packaging formulations for smaller devices. Both strain gauge and beam bending experiments showed comparable stress levels with these two materials. The third material is a rubber modified, low stress material. As expected, stress levels in devices packaged with this material, as well as stresses observed in the beam bending apparatus, were considerably lower than those for the other two materials. 

The overall system of containment may consist of more than one material of containment. Glass ampoules are the most obvious example of a single-material containment system. Vials consist of a glass container and a rubber or polymeric closure. Some device packages may have one side consisting of an opaque material printed with instructions for use and the other side of a transparent material allowing the consumer to see the contents. For systems of containment an extra dimension of complexity is introduced into the most important of the... 

DISPOSAL AND STORAGE METHODS dissolve in flammable solvent and bum ii mctnerator equipped with afterburner and effluent gas cleaning device package solid acid ii paper and bum in an incinerator store in a dry, well-ventilated location separate from oxidizinj materials and alkaline substances. 

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