The lyophilizer installation steam sterilization system online ( SIP) steps

by:CBFI     2020-10-11
The lyophilizer installation online pure steam sterilization system ( SIP) Is the first choice for the lyophilizer modification method and is accepted without objection of the lyophilizer sterilization method. But before the installation must confirm that the following conditions:

(1) the lyophilized machine manufacturing is designed according to the pressure vessel, pressure vessel design and test certificate and registration certificate.

(2) the lyophilizer heat exchange system ( The heat conduction oil circulation system of all the device) Must be designed by using silicone oil as a heat conduction oil.

3. Pure steam system can guarantee the supply.

if the above conditions can be achieved, then the machine can be equipped with the SIP system meet the requirements of GMP. With this machine the original manufacturer ( With pressure vessel design and manufacture of certificate) Contact is modified. If you want to contact other than the original manufacturers should pay special attention to whether there is a pressure vessel certificate and compatibility of automatic control system.

if the above conditions of any items not reach, then you must not good since addition SIP system. Reason:

1) configure the SIP system lyophilizer drying cabinet and vacuum condenser belong to D class pressure vessel, on which the design and production of cold box and hydrazine is much more complex than ordinary lyophilizer. General equipment will be converted into pressure vessel, illegal 'regulations on the administration of pressure vessel, it is illegal, once an accident will be investigated for legal responsibility, guangdong has exploded in the steam sterilization process cause person casualties, clean workshop collapse of the blood of the lesson.

2. Configure the SIP system in design and manufacture of the lyophilizer is to use silicon oil as a heat conduction oil, while the common 4 - freeze-drying box is adopted 4 - 2 the ternary mixture of heat conduction oil or other liquid, the boiling point of two kinds of heat conduction oil, freezing point, thermal conductivity, kinematic viscosity, specific heat, coefficient of thermal conductivity, density, heat transfer efficiency is different, so the heat exchanger area, plate layer area, circulating pump, such as configuration are different, if only change the heat conduction oil, freeze-drying curve is difficult to control, freeze-dried failure may occur or extended production cycle, and so on and so forth.

(3) the lyophilizer for pure steam sterilization of steam consumption is larger, You may refer to specific number steam sterilization cabinet conversion) In pulse and temperature stage, pure steam supply guaranteed, otherwise will further extend the sterilization cycle, and disturb the original steam or production plan.

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