PENERAPAN METODE DMAIC GUNA MENGURANGI KERUSAKAN KOLOM HPLC TIPE C-18, 250 X 4 MM DI LABORATORIUM QC PT. MF

ISLAMIA, NUR (2019) PENERAPAN METODE DMAIC GUNA MENGURANGI KERUSAKAN KOLOM HPLC TIPE C-18, 250 X 4 MM DI LABORATORIUM QC PT. MF. S1 thesis, Universitas Mercu Buana Jakarta.

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Abstract

PT. MF is a company engaged in the pharmaceutical with the end product of quality drugs. Good drug quality can be guaranteed with the right quality control, while the right quality control is by checking the drug level by using High Performance Chromatography Liquid (HPLC) machine with the most important part is HPLC column. During the period of January - December 2017, the HPLC column of type C-18, 250 x 4 mm often suffered damage by 10.20% with a sigma value of 3.14 this has exceeded the predetermined target of 2.0%. The purpose of this research is to find factors causing damage of column, give suggestion of repair and compare result before and after repair by using DMAIC method so that factor causing damage of HPLC column in factor method is HPLC column leaching process not according to supplier recommendation can be done that is make HPLC column leaching procedure in accordance with supplier recommendation, and do training related HPLC column leaching. By applying the proposed improvements and controls, the proposed improvements can be effective and efficient so as to reduce the damage of C-18, 250 x 4 mm HPLC columns and increase the sigma value during the January - May 2018 period of 1.70% and 3, 89. Keywords : Quality, HPLC Column Damage, DMAIC, Sigma Value. PT. MF merupakan perusahaan yang bergerak dibidang farmasi dengan produk akhir berupa obat yang berkualitas. Kualitas obat yang baik dapat dijamin dengan pengawasan mutu yang benar, adapun cara pengawasan mutu yang benar yaitu dengan memeriksakan kadar obat dengan menggunakan mesin High Performance Chromatography Liquid (HPLC) dengan bagian terpentingnya yaitu kolom HPLC. Selama periode Januari – Desember 2017 kolom HPLC tipe C-18, 250 x 4 mm sering mengalami kerusakan sebesar 10,20 % dengan nilai sigma sebesar 3,14 hal ini telah melampaui target yang telah ditetapkan perusahaan yaitu sebesar 2,0 %. Tujuan dari penelitian ini yaitu mencari faktor penyebab kerusakan kolom, memberikan usulan perbaikan serta membandingkan hasil sebelum dan sesudah perbaikan dengan menggunakan metode DMAIC sehingga didapatkan faktor penyebab kerusakan kolom HPLC pada faktor metode yaitu proses pencucian kolom HPLC yang tidak sesuai dengan rekomendasi supplier sehingga usulan perbaikan yang dapat dilakukan yakni membuat prosedur pencucian kolom HPLC sesuai dengan rekomendasi supplier, dan melakukan training terkait pencucian kolom HPLC. Dengan menerapkan usulan perbaikan dan control yang ada, usulan perbaikan tersebut dapat berjalan efektif dan efisien sehingga dapat menurunkan kerusakan kolom HPLC tipe C-18, 250 x 4 mm dan meningkatkan nilai sigma selama periode Januari - Mei 2018 sebesar 1,70 % dan 3,89. Kata kunci : Mutu, Kerusakan Kolom HPLC, DMAIC, Nilai Sigma.

Item Type: Thesis (S1)
Call Number: ST/16/18/052
NIM: 41616110011
Uncontrolled Keywords: Mutu, Kerusakan Kolom HPLC, DMAIC, Nilai Sigma.
Subjects: 300 Social Science/Ilmu-ilmu Sosial > 320 Political dan Government Science/Ilmu Politik dan Ilmu Pemerintahan > 322 Relation of The State of Organized Groups/Hubungan Negara dengan Kelompok Sosial yang Terorganisir > 322.3 Business and Industry/Bisnis dan Industri
700 Arts/Seni, Seni Rupa, Kesenian > 720 Architecture/Arsitektur
700 Arts/Seni, Seni Rupa, Kesenian > 720 Architecture/Arsitektur > 725 Public Structures Architecture/Arsitektur Struktur Umum
700 Arts/Seni, Seni Rupa, Kesenian > 720 Architecture/Arsitektur > 725 Public Structures Architecture/Arsitektur Struktur Umum > 725.4 Industrial Buildings/Bangunan Industri
700 Arts/Seni, Seni Rupa, Kesenian > 740 Drawing and Decorative Art/Menggambar dan Seni Dekorasi > 745 Decorative Arts/Seni Dekorasi > 745.2 Industrial Design/Desain Industri
700 Arts/Seni, Seni Rupa, Kesenian > 750 Painting and Paintings/Seni Lukis dan Lukisan > 758 Other Subjects/Subjel Lainnya > 758.6 Industrial and Technical Subjects/Subjek Industri dan Teknik
Divisions: Fakultas Teknik > Teknik Industri
Depositing User: Dede Muksin Lubis
Date Deposited: 22 Feb 2019 03:18
Last Modified: 22 Feb 2019 03:18
URI: http://repository.mercubuana.ac.id/id/eprint/47275

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