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What Does Validatable Mean?

Validation is a means by which precise data can be measured and logged. As it pertains to vacuum sealing, validatability consists of:
  1. Continuous verification of temperature while operational
  2. Continuous verification of speed while operational
  3. Continuous verification of sealer bar pressure while operational
Features of a validatable vacuum sealer typically include seal time control, pressure control and temperature control, as well as calibration ports. The data is output to the Programmable Logic Controller (digital computer), by way of an RS-232 cable, and recorded.

The International Packaging Standard ISO 11607-2 calls for suitable validated packaging processes for medical devices. This standard is applicable to the medical industry, to health care facilities (hospitals, doctors and dentists), and wherever medical devices are manufactured, packaged and sterilized.

The Defense Contract Management Agency has outlined a series of packaging regulations as set forth in MIL-STD-2073, which requires extensive testing and validation in the packaging of military products.

While both ISO 11607-2 and MIL-STD-2073 require validation during the packaging process, the use of a validatable vacuum sealer can benefit anyone. Precise data output and controls virtually eliminate human error from the packaging equation , resulting in a better vacuum and seal, as well as better shelf life for your product.



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