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Medical equipment industry
High performance, high risk?
Vulnerability is the fatal weakness of the electronics industry. Electronic products become smaller and smaller, more resistant to shock and vibration sensitive. Especially the high-end products and hardware.
For example, satellites often rely on laptop hard drives. Missiles, which are often transported, are bumps and drops in danger, which can damage computer parts and break fine joints or solder joints.
Just by the impact of falling, vibration and resonance there is also a serious risk. In normal transportation, electronic components or assemblies are usually subjected to 1G random vibration frequencies ranging from 3 to 50 Hz for 20 minutes. However, structural vibration with the chassis of trucks and train compartments, the vibration frequency will reach 70 Hz, and vibration from the rail joints range from 30 to 300 Hz. The frequency of vibration of the ship's bulkhead and freight planes varies from 2 Hz to 200 Hz.
Appropriate packaging, to reduce the impact of some of these vibrations and shocks. A "suitable package" designed by the package designer prevents the device from contacting the sides of the box and has sufficient elasticity to dampen shocks and vibrations.
Even if there is an adequate risk of packaging there is a risk of change in the mode of transport or environmental conditions or the threat of unexpected events - reliable packaging can do only so much. The shipper must know whether the damage occurred. When a comprehensive shock and vibration monitoring program is available, the damaged equipment can be identified prior to installation, and the risk of damage can be reduced by adjusting the logistics operations to reduce future damage.
Temperature will also be affected. Computer chip-driven analytical equipment is susceptible to heat, and humid gases. The equipment used tends to use DNA testing, which reduces the effect of high temperatures. Likewise, the reagent may be damaged by an impression of temperature.
In order to minimize these risks, the regulatory body is required to comply with GMP 820.130 and meet packaging performance testing standards such as ISO 11607 and ASTM D4169.
However, if an error how to deal with? Impact Indicators Identify vibrations, drops, and temperature changes during transport and storage, so that defective items should be inspected before installation or implantation so that manufacturers, hospitals and patients benefit.
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