EVALUATION OF TABLETTING MACHINE CAPABIL-ITY BY STATISTICAL PROCESS CONTROL METHOD – A CASE STUDY

B.R.Kirupakar; Dr.B.A.Vishwanath; M. Padma Sree; P.Vinoth Kumar; R.Mathivannan

Authors

B.R.Kirupakar Aditya Bangalore Institute Of Pharmaceutical Education And Research, Rajiv Gandhi University Of Health Sciences, Karnataka.
Dr.B.A.Vishwanath Aditya Bangalore Institute Of Pharmaceutical Education And Research, Rajiv Gandhi University Of Health Sciences, Karnataka.
M. Padma Sree Aditya Bangalore Institute Of Pharmaceutical Education And Research, Rajiv Gandhi University Of Health Sciences, Karnataka.
P.Vinoth Kumar R&D, Malaysian Pharmaceuticals Industries Sdn.Bhd.,Malaysia
R.Mathivannan R&D, Malaysian Pharmaceuticals Industries Sdn.Bhd.,Malaysia

Keywords:

Statistical Process Control, Tablet Compression Machine, Process Capability, Control Chart

Abstract

This case study discusses the use of statistical process control (SPC) for evaluating tablet compression machine capability and efficiency in pharmaceutical industry. The tablet compression process is found to be out of control in compression machine A since the process capability indices for hardness parameter is Cp = 1.2 and Cpk = 0.9. Inthis case the process is not centered and has chance for producing tablet out of specification limit. The compression machine B and C is capable of producing the tablets with the hardness within pre-determined specification limit. In this case the tablet hardness is spread within the specification range and the process is centered and found to be in control with process capability indices more than 1. The study found that though the hardness of the tablet compressed in the compression machine A, B and C are within specification limit, the tablet from compression machine A has chance to fall outside the specification limit and suggest to closely monitor during the compression in Machine A for this product.

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