Lyophilization Validation冻干验证
This will give assurance that the specified critical parameters of temperature and pressure are achieved, thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21CFR 610.13 will be satisfactory.
Although thermocouples and pressure transducers can be connected to a logger/recorder outside the process chamber for lyophilization validation, this can be difficult because of the very low pressures, typically in the range of microbars, or fractions of a Pascal, required by the process.
Loggers such as TMI-Orion NanoVacq 1Tc-2Td (-80°C to +130°C) are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.
For more details please visit our Thermal Validation Systems page.
This will give assurance that the specified critical parameters of temperature and pressure are achieved, thereby increasing assurance…
这将确保达到指定的温度和压力关键参数，从而进一步确保 FDA 根据 21CFR 610.13 发布的残留水分标准的确定将令人满意。
尽管热电偶和压力传感器可以连接到工艺室外的记录仪/记录仪以进行冻干验证，但这可能很困难，因为工艺所需的压力非常低，通常在微巴或帕斯卡的几分之一范围内。
THP ValidatorTHP-T01（-80°C 至 +130°C）等记录仪更适合该应用。 TQSoft™ 热验证软件与THP 记录仪兼容。
有关更多详细信息，请访问我们的热验证系统页面。
这将保证达到指定的温度和压力关键参数，从而提高保证……
THP Validator THP-T01（-80°C 至 +130°C）等记录仪更适合该应用。
THP Validator无线温度检测仪可以进行冻干机SIP在线灭菌验证、冻干机板层温度均匀性验证。
欲了解更多信息，请联系我们的产品经理和验证工程师
Tel：021-68902733,18302112429
Lyophilization Validation冻干验证
