Method and system for on-line monitoring medicaments production mixing process

Abstract

The invention discloses a method for monitoring a mixing process of pharmaceutical production on line, comprising the following steps: an optical sensor on a mixing tank senses near infrared absorbance spectrums of mixed materials and transmits the spectrums to near infrared real time measuring equipment; the near infrared real time measuring equipment samples the spectrums within a given sampling period and transmits sampling data to an online supervisory control computer; the online supervisory control computer processes the sampling data and reaches a conclusion on homogeneous state of the mixing process; the online supervisory control computer forms a control instruction according to the conclusion, and the control instruction is used for controlling a motor of the mixing tank to perform real-time adjustment on operating conditions of the mixing tank. The method and a system for monitoring the mixing process of pharmaceutical production on line of the invention can process a plurality of characteristic sequences during the mixing process of pharmaceutical production and automatically reach a conclusion on homogeneous degree; the method and the system are suitable for automated processing of pharmaceutical production and guarantee quality of the mixing process of pharmaceutical production.

Description

technical field [0001] The invention relates to a method and system for monitoring the production process of medicines, in particular to an online monitoring method and system for the mixing process of medicine production. Background technique [0002] In the prior art, the mixing process of drug production is an essential key link in drug production and one of the key unit operations that affect the quality of drugs. The purpose of mixing is to ensure the uniform distribution of pharmaceutical active ingredients and other various additives, and ultimately ensure the consistency of product content. The proportion of materials in mixing and the uniformity of mixing will directly affect the subsequent production and drug quality. Incomplete mixing or "over-mixing" will lead to uneven product content, resulting in batches of pharmaceutical products being unqualified. On-line monitoring of the drug production mixing process can improve its quality and efficiency, and reduce ove...

AI Technical Summary

Problems solved by technology

[0005] In the above-mentioned prior art, the manual sampling analysis method is not only time-consuming and laborious, but also samples at non-uniform discrete time points based on experience, and the detection results obtained in this way are difficult to analyze the mixed The uniformity of drug ingredients in the process can be expressed macroscopically, so the judgment results are prone to bias

In the prior art, the Antaris Target dedicated mixing process on-line detector adopted by Thermoelectric Corporation of the United States can give some characteristic change curves in the drug mixing process in real time, but the final judgment of the degree of uniformity still needs to be determined by observing the characteristic change curves. In this way, in the face of critical situations such as "close to uniformity" and "over-uniformity", it is difficult for human eyes to give an accurate conclusion and judgment. Therefore, it is still easy to cause deviations in the production process and cannot adapt to the automation of the production process. need

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