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Manufacturing pharmaceutical lyophilizer scale-up method

As the bottle preparation of freeze-dried test amplified to pharmaceutical manufacturing method of the lyophilizer. Necessary based on the experimental conditions of freeze-dried, medicine bottles on the shelf of the heat transfer and sublimation from surface moving in the flow of water vapor through the dry layer through theoretical analysis, the testing machine, drying procedure to production device, the specific steps are as follows:

1, the liquid medicine freeze-dried condition of machine manufacturing and result analysis
( 1) On tester shelf size, body size, is with the bottom tray or draw the bottom pallet for confirmation.

( 2) Precool project: shelf cooling speed, whereas the freezing rate, freezing temperature and freezing time.

( 3) Sublimation drying: extraction time, the early board floor heating temperature, heating rate, sublimation period products temperature changes. Sublimate in the vacuum ( Whether control) , control mode, The throttling control, or aeration control) , vacuum instrument ( Is skin, or absolute pressure vacuum gauge) In the casing wall, sublimation drying time and test temperature.

( 4) The second stage drying: shelf temperature, vacuum box, condenser temperature, drying time in the second stage.

( 5) Freeze-drying curve analysis: will the sublimation drying products temperature compared with products of melting temperature, freeze-drying curve from the record, to end the bottle, the bottle to the center of the shelf and products the difference in temperature and the drying time of product & Delta; T﹡θ To calculate.

( 6) End of tester bottle, the bottle to the center of the heat and water vapor mobile theory analysis.

( 7) According to the theory of analytical and experimental results of the dry layer water vapor flow resistance coefficient estimation.

2, zoom in to a production device
( 1) For the production device shelf confirm size, body size, etc.

( 2) The basic properties of the production equipment and testing machine were compared. If the shelf production device cooling speed is faster than testing machine, the production equipment of liquid freezes faster, with the size of the ice crystal column have differences, dry layer of water vapor flow resistance will increase, affect sublimation rate.

( 3) For the production device radiation heat transfer coefficient to calculate the Angle, and compared with testing machine.

( 4) Preliminary freezing engineering: will freeze speed, freezing time set the same as the tester, and considering the air convection effect on freezing engineering.

( 5) Sublimation drying stages: set vacuum box and shelf temperature process, the drying speed theory analysis, to the end, the bottle to the center of heat transfer and vapor flow resistance in dry layer theory calculation, in order to the sublime surface temperature and the sublimation drying time.

( 6) The second stage drying: heat the shelf temperature setting is the same as the testing machine, vacuum box as far as possible consistent with the tester, and controls the temperature of the condenser.

3, production device vacuum pressure control values of selected
when to enlarge production device, cabinet vacuum pressure control values of selected the following factors must be considered.
( 1) The collapse of the product temperature

as the products of low melting point temperature, sublimation of the water vapor pressure PS values must be reduced, because of the dry layer has a pressure difference, the box body of the vacuum pressure must be controlled in a smaller value. In the sublimation drying time, sublimation surface temperature than the collapse temperature should be lower than 2 ~ 5 ℃.
( 2) Products dry layer of water vapor flow resistance

dry steam flow resistance in the porous layer and the concentration of the solution, bottle filling amount, frozen ice crystals with column form. Vacuum pressure box selected for sublimation surface vapor pressure for PS 10 ~ 30%.
( 3) And tester of vacuum pressure control values also set a regular

if the testing machine for leather, vacuum gauge, vacuum gauge will be expected to pull skin, gage count converted to the real value, thereby producing machine of condenser vacuum gauge with vacuum value as the cabinet vacuum pressure control values.
4, production machine shelf temperature program set
in the production of machine shelf temperature program set has the following two methods.
( 1) Same as the tester shelf heating temperature setting, extend the sublimation drying time.

for production with freeze-drying machine, heat transfer to the center of the bottle less heat than testing machine, drying speed slow. If no longer sublimation drying time, the first stage of the production the bottle to the center of the lyophilizer drying time in not frozen state, entered the second phase is dry, the shelf temperature to heat up, can produce products at the bottom of the local collapse, lead to products scrapped.
( 2) Equal to machine drying time

to set the production of the lyophilizer shelf heating temperature for temperature a little higher than tester, in order to achieve equal to test the lyophilizer is dry, but must carry on the theoretical analysis.

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