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W Honda

Publications and source records attributed to W Honda.

7 recordsLinked to original sources
PubMedDate not supplied

Validation of a microwave sterilizer for injection ampules.

A program for validating the microwave sterilizer, which is a new type of sterilizer, was established and implemented. This program includes the following tests specific to microwave sterilizers: the internal pressure strength of ampules, the acceptable range of sterilizing temperature, performance and calibration of the infrared thermometer and the plane blackbody, maintaining of sterilizing temperature, the processing speed (sterilizing time), the unacceptable ampules selection mechanism, microwave leaks, and a microbiological challenge test of the ampule head space using a biological indicator. Injectable preparations of mecobalamin and diprophylline were used as models for validation of the microwave sterilizer. The bioburden approach was used for injectable mecobalamin preparation, and the over-kill approach was used for injectable diprophylline preparation. The basis for practical use of this microwave sterilizer has been confirmed by the establishment and implementation of this validation program.

Drug Packaging↗
PubMedDate not supplied

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.

Drug Stability↗
PubMedDate not supplied

Evaluation of high-temperature and short-time sterilization of injection ampules by microwave heating.

The high-temperature and short-time sterilization by microwave heating with a continuous microwave sterilizer (MWS) was evaluated. The evaluation were performed with respect to: [1] lethal effect against microorganisms corresponding to F-value, and [2] reliability of MWS sterilization process. Bacillus stearothermophilus ATCC 7953 spores were used as the biological indicator and the heat-resistance of spores was evaluated with conventional heating method (121-129 degrees C). In MWS sterilization (125-135 degrees C), the actual lethal effect against B. stearothermophilus spores was almost in agreement with the F-value and the survival curve against the F-value was quite consistent with that for the autoclave. These results suggest that the actual lethal effect could be estimated by the F-value with heat-resistance parameters of spores from lower than actual temperatures and that there was no nonthermal effect of the microwave on B. stearothermophilus spores. The reliability of sterilization with the MWS was confirmed using more than 25,000 test ampules containing biological indicators. All biological indicators were killed, thus the present study shows that the MWS was completely reliable for all ampules.

Geobacillus stearothermophilus↗
PubMedDate not supplied

Selection of biological indicator for validating microwave heating sterilization.

For the purpose of selecting an appropriate biological indicator for evaluation of the effects of microwave heating sterilization, we examined aerobic bacterial spores to determine whether microwaves have non-thermal sterilization effects. After microwave irradiation on dry bacterial spores (three species), none of the bacterial spores were killed. The survival rate of the spores after microwave irradiation of spore suspensions (twelve species) was compared with that after heating by a conventional method. The order of heat resistance in the bacterial species was similar between the two heating methods. Bacillus stearothermophilus spores were the most heat-resistant. These results suggest that microwaves have no non-thermal sterilization effects on bacterial spores, the specific resistant spores to microwave heating, and microwave heating sterilization can be evaluated in the same way as for conventional heating sterilization. As a biological indicator for evaluation of overkill sterilization, B. stearothermophilus spores may be appropriate for microwave heating sterilization as well as steam sterilization.

Bacteria↗