Pilchik R
Mocon, Minneapolis, Minnesota, USA.
Med Device Technol. 2001 Nov;12(9):45-7.
Strength and integrity are the two attributes that must be monitored at the critical point. Strength can effectively be monitored by operating the sealing equipment within the validated control limits. Integrity is another matter entirely. Integrity failures are often random occurrences that must be visible to the trained operator. Yet, this is not true in every instance. Use of precise testing equipment, which exceeds the capabilities of visual testing, is a more effective way to manage the critical control point. New technology to more effectively test the attributes of seal and package integrity at the critical control point is currently under development. Data on its capabilities will shortly be available.
强度和完整性是在关键控制点必须监测的两个属性。通过在经过验证的控制限度内操作密封设备，可以有效地监测强度。而完整性则完全是另一回事。完整性故障往往是随机发生的，必须让经过培训的操作人员能够看到。然而，并非在每种情况下都是如此。使用超越目视检测能力的精密检测设备，是管理关键控制点的更有效方法。目前正在开发能够在关键控制点更有效地检测密封和包装完整性属性的新技术。关于其性能的数据很快就会公布。
