Microwave continuous sterilization of injection ampoules.
A new microwave continuous sterilizer (MWS) for applying microwave dielectric heating as an alternative to an autoclave was developed. The developmental objectives of the MWS were: 1. Achieving sufficient sterilization for the drugs containing heat-sensitive ingredients. 2. Measuring and recording sterilization temperature of each ampoule. 3. Ensuring automatic continuous operation and linkage with the preceding and following machines in an injection ampoule production process. The temperature of the drug solution in an ampoule was heated to 140 degrees C within about 30 seconds by the MWS. Target F0 value is achieved through the maintaining heater to maintain the target temperature for 12 seconds. Ampoules are cooled with air and water after completion of heating. The MWS is capable of processing 150 ampoules per minute. The newly developed techniques which minimized temperature distribution of heated ampoule solution were: 1. Microwave irradiation in a direction opposite to the direction of ampoules transportation. 2. Microwave irradiation in the lower part of ampoule solution (i.e., heating up the drug solution by thermal convection.) 3. Microwave power control by feedback of measured temperatures. 4. Heating rate control corresponding to the dielectric property of ampoule solution. The drug stability test was performed using 3% pyridoxamine phosphate solution, and the inactivation of spores in 3% pyridoxamine phosphate solution was examined using Bacillus stearothermophilus ATCC 7953 spores. The MWS was proved to have an adequate efficiency of sterilization with less chemical degradation of the contents than an autoclave.
Sasaki
K
K
Quality Control Department, Misato Factory, Eisai Company, Limited, Gifu, Japan.
Honda
W
W
Shimizu
K
K
Iizima
K
K
Ehara
T
T
Okuzawa
K
K
Miyake
Y
Y
D004355:Drug Stability; D007267:Injections; D008872:Microwaves; D012996:Solutions; D013242:Sterilization; D013696:Temperature
D012996:Solutions