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A Soft Tooling Process Chain for Injection Molding of a 3D Component with Micro Pillars
Published on: August 4, 2018
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[Study on manufacturing process performance index of Qingkailing injection]
Summary
Process performance indexes (PPIs) like P(pk) effectively assess Chinese medicine quality consistency. The P(pk) index is more sensitive than P(p), highlighting areas for improved quality management in traditional medicine production.
Area of Science:
- Quality control in traditional Chinese medicine (TCM) manufacturing.
- Statistical process control (SPC) methodologies.
- Analytical chemistry and pharmaceutical quality assessment.
Context:
- Chinese medicine products require robust quality control to ensure consistency and safety.
- Traditional methods of quality assessment may not fully capture process variability.
- Evaluating process capability is crucial for optimizing TCM production.
Purpose:
- To introduce and apply process performance indexes (PPIs), specifically P(p) and P(pk), for assessing Chinese medicine quality.
- To estimate confidence intervals for P(p) and P(pk) using Bootstrap sampling methods.
- To analyze the process capability of Qingkailing injection based on historical quality data.
Summary:
- The study applied P(p) and P(pk) indexes to historical quality data of Qingkailing injection, using Bootstrap methods for confidence intervals.
- Results indicated P(pk) is more sensitive than P(p) for process capability analysis.
- Qingkailing injection exhibited varying process capabilities across different quality indexes, with total nitrogen requiring enhanced quality management.
Impact:
- Demonstrates the effectiveness and feasibility of PPIs for practical application in Chinese medicine production.
- Provides a quantitative method for identifying specific areas needing quality improvement in TCM manufacturing.
- Enhances the understanding of process capability and quality consistency in the traditional Chinese medicine industry.

