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Analisis Pengendailah Kualitas Obat Sediaan Kaplet Salut Selaput P@ Memalui Penerapan Statistical Process Control di PT.YF (Analisis ofP@ Film-Coated Caplet Quality Control by Implementing Statistical Process Control Method at PT.YF)

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Manufacturing of film-coated caplet dosage form is a multi-steps process, including weighing, blending, granulating, compression, coating, and packaging. Every manufacturing process is influenced by natural variation and assiginable variation which caused the process operates out-of control and interfering consistency and attainment of output quality specification. Based on the above backhround a research was conducted upon manufacturing process of of P@ film coated caplet at PT.YF. This research was limited for core caplet compression step and film coating step Instead of entire production process. The purposes of this research were analyzing core caplet compression process and coating process and measuring process capability of those steps in meeting the pre-determined quality specifications. Investigations. Investigation of 20 latest consecutive batch record decuments within 2009 period was conducted in collecting quantitative data measurement of caplet quality characteristics including weight uniformity, hardness, friability, disintegration, and dissolution of drug substane of p film coated caplet. Those data were analyzed using control chart SPC method and process capability was measured by Cpk index. The results showed that from caplet core compression step the control chart of caplet weight control chart of hardness; disintegration time and dissolution of paracetamol; control chart of hardness; disintegration time and dissolution of paracetamol ; control chart of hardness; disintegration time anddissolution of control. The result of film coating step of p film – coated caplet showed that the control chart of weight uniformity; hardness and Ibuproblem dissolution indicates statistically was statistically in control. The process capability index, CPK. Of core caplet weight uniformity; 1.375, and paracetamol P film-caated caplet dissolution: 1.841.

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Detail Information

Series Title

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Call Number

Majalah Farmasi Indonesia,22(1)2011:33-42

Publisher

Yogyakarta : Fakultas Farmasi UGM., 2011

Collation

9p.

Language

ISBN/ISSN

0126-1037

Classification

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Content Type

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Media Type

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Carrier Type

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Edition

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Subject(s)

membranes
DRUG MONITORING

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