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User Success Story: Helping a major pharmaceutical manufacturer improve the accuracy of their granulation and coating processes and maintaining a stable quality level all while improving the washability of the equipment.

Succeeding in the research and development of new drugs that require high precision of granulation and coating. Trials were also progressing and there was a rush for approval for commercial production.

Pharmaceutical Manufacturer K

Production Engineering Department

Problem:

・Could not meet the required accuracy for their granulation and coating processes.

At Manufacturer K, which specializes in the research and development of new drugs, it was necessary to develop a manufacturing progress for commercial production and carry out the validation. The new drug requires very high precision in controlling the release rate of sustained release granules. In order to achieve this level of precision, it is necessary to first produce a uniform particle size during the granulation process, and then uniformly spray the suspension evenly in the coating process to construct a line that could achieve the high reproducibility they required.

Mr. Y of the Production Engineering Department carefully scrutinized the condition settings of the equipment that perform the granulation and fine particles coatings. However, a variation in the particle size and an unevenness of the coating was still occurring. No matter how many adjustments to the existing equipment Mr. Y made, they could not reach their desired level of accuracy. He began to doubt that there was a problem with the whole system, and even tried to perform a detailed maintenance procedure, but no fault was found anywhere and the cause of his problem could not be identified.

Problem Points:

・During the granulation process, the particle size is no uniform.

・The coating is uneven and the quality does not their quality standards.

Solution:

Solution Points:

・By replacing the pump with one with very high transfer accuracy, the particle size and coating thickness could be made uniform.

・Reproducibility, which is essential for the commercial production of sustained release granules, was achieved at a very high level.

-The high precision pump installed by the major pharmaceutical manufacturer K

Improvements in the accuracy of his existing equipment did not progress, so Mr. Y decided to consult with the salesperson of the equipment system manufacturer. At this time, he was advised to try to change the pump. Therefore, the system’s salesperson recommended trying a Tacmina Smoothflow Pump, which was eventually implemented by the major pharmaceutical manufacturer K. Upon hearing that if he replaced his existing pump with a Tacmina Smoothflow Pump, the accuracy of the liquid transfer would improve dramatically, Mr. Y decided to inquire with a Tacmina sales representative.

The Tacmina representative explained that the Smoothflow Pump has no pulsation, which allows for uniform delivery, and has a very low risk of the generation of foreign matter. “The price of the pump was a bit more expensive that the existing pump I was already using, but since I could not improve the accuracy with my existing equipment, I decided to do a production trial test with a rental Smoothflow Pump from Tacmina,” Mr. Y explained.

-“The accuracy and overall quality were drastically improved, and the cleaning and maintenance procedures are easy!”

Replacing the previous pump with a Smoothflow pump dramatically improved the granulation and coating accuracy. The granulation became uniform and coating unevenness was eliminated. Given the excellent results of the trial with a rental Smoothflow Pump, Mr. Y decided immediately to implement the Smoothflow Pump into his system. This helped ensure that Manufacturer K can produce controlled release granules that met their required standards criteria.

“Not only did the overall accuracy and quality improve, but the maintenance procedure became much easier as well. I was told that the excellent washability of the pump would also be a good advantage for our pharmaceutical industry, but once I actually tried to use it, I was convinced! I truly understood why this Smoothflow Pump was nominated for implementation,” Mr. Y said.

Validation of the new drug has been successfully completed, and approval of the application has also been cleared. Manufacturer K was able to build a production line that achieves the high level of repeatability they require, and they have already begun commercial production of the new drug.

Coated Pill Capsules

Details

  • Osaka, Japan
  • TACMINA CORPORATION