APLIKASI STATISTICAL PROCESS CONTROL (SPC) PADA PENGENDALIAN KUALITAS KAPLET ANTIBIOTIK SECARA KEMPA LANGSUNG
Antibiotic caplet production process in direct compress consist of some process steps, that are weighing, blending (mixing), compression, and packaging. Every production process affected by common causes (natural variation) and special causes (assignable variation) which causes quality difference of...
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| Main Authors: | , |
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| Format: | Theses and Dissertations NonPeerReviewed |
| Published: |
[Yogyakarta] : Universitas Gadjah Mada
2014
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| Online Access: | https://repository.ugm.ac.id/128597/ http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=68950 |
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| Institution: | Universitas Gadjah Mada |
| Summary: | Antibiotic caplet production process in direct compress consist of some process steps, that are weighing, blending (mixing), compression, and packaging. Every production process affected by common causes (natural variation) and special causes (assignable variation) which causes quality difference of characteristics caplet. Special causes can make production process is not in control and output cannot be predicted to the coming production so that impact to consistency and specifications of output quality. This research aims to analyse the production processes controllability of the mixing stage and the compression stage of antibiotic caplet with Statistical Process Control (SPC) and determine specific causes which make production processes of the mixing stage and the compression stage are not in control statistically in pharmaceutical industry.
Quantitative datas of caplet quality characteristics in the mixing stage (homogeneity) and the compression stage (uniformity of weight, hardness, friability, disintegration time, levels of the active substance) traced of 25 batches record documents from the final production alternately periods of year 2012 in industry then they are analyzed by Statistical Process Control (SPC) with control charts tool to know the controllability process. Process is not control which marked existence of unusual patterns in control charts is continued with analysis of cause and effect diagram. Assignable variations make out-of control process analysed with interpreting unusual patterns in control charts with result of deep discussions in the production and quality control section then cause and effect diagram is made.
The results of research indicated that the processes production of mixing stage and compression stage of antibiotic caplet are not in control statistically and specific causes which make the processes are out of control caused by machine factors that are the mixer machine condition is old, rotary machine is old which its punches and dies are incomplete and measurement tools are not calibrated regularly. |
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