LAKSONO, PRAMBUDI CAHYO (2022) PENETAPAN BATAS STANDAR KENDALI LABORATORIUM PADA PRODUK JADI LARUTAN INFUS DENGAN METODE STATISTICAL PROCESS CONTROL (SPC) DI PERUSAHAAN FARMASI. S1 thesis, Universitas Mercu Buana Bekasi.
|
Text
41617310029 - Prambudi Cahyo Laksono - 02 Cover.pdf Download (330kB) | Preview |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 03 Abstrak.pdf Download (31kB) | Preview |
|
![[img]](https://repository.mercubuana.ac.id/style/images/fileicons/text.png) |
Text
41617310029 - Prambudi Cahyo Laksono - 04 BAB 1.pdf Restricted to Registered users only Download (237kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 05 BAB 2.pdf Restricted to Registered users only Download (891kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 06 BAB 3.pdf Restricted to Registered users only Download (233kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 07 BAB 4.pdf Restricted to Registered users only Download (608kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 08 BAB 5.pdf Restricted to Registered users only Download (300kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 09 BAB 6.pdf Restricted to Registered users only Download (226kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 10 Daftar Pustaka.pdf Restricted to Registered users only Download (190kB) |
|
|
Text
41617310029 - Prambudi Cahyo Laksono - 11 Lampiran.pdf Restricted to Registered users only Download (211kB) |
Abstract
ABSTRAK Pertumbuhan industri farmasi Indonesia memiliki rata menyebabkan persaingan pasar yang cukup tinggi. rata tinggi, dan Pada perusahaan farmasi penelitian dilakukan, menghasilkan produk dengan volume yang fluktuasi tinggi, sehingga terdapat pengaduan dari customer produk. Untuk memberikan keyakinan yang mempertanyakan konsentrasi dari terhadap jaminan kadar larutan produk y dihasilkan, maka diterapkan batas pengendalian laboratorium. Batas ang tersebut diperoleh dengan menggunakan metode mutu laboratorium yang dicari yaitu SPC Warning itu dicari ta hu juga faktor. Pada penelitian yang dilakukan batas Limit dan Action Limit , selain tersebut yang mempengaruhi nilai analisa kadar serta kemampuan proses analisa yang telah berjalan. Data penelitian dikumpulkan dari pengujian tren data kimia kadar natrium dan klorida pada tahun 2020, data tersebut kemudia diolah dengan menggunakan software MiniTab 19. Dari n hasil perhitungan d idapatkan nilai batas nilai kendali laboratorium warning limit untuk natrium: LWL;UWL N ilai = 152.7, action limit 157.9 mmol/l dan klorida : LWL yang didapatkan untuk natrium : ; UWL LAL ; = 153.9 UAL ; 158.3 = 151.4; mmol/l;. 159.2 mmol/l dan klorida : LAL;UAL kemampuan proses = 152. 9; 159.4 mmol/l. bahwa proses yang berjalan D idapatkan kurang yang mempengaruhi hasil dari analisa kada terkualifikasi, validasi r produk jadi capable yaitu di juga serta hasil analisa faktor antaranya faktor personel motede analisis, sampling produk, pereaksi & standar yang dipakai dan kualifikasi dari instrumen . Kata Kunci : SPC, Batas Kendali Laboratorium, iv Warning Limit , Action Limit ABSTRACT The growth of the Indonesian pharmaceutical industry has a high average, and causes quite high market competition. In pharmaceutical companies, research is carried out, pr oducing products with high fluctuating volumes, so that there are complaints from customers who question the concentration of the product. To provide confidence in the guaranteed level of the resulting product solution, laboratory control limits are applie d. The limit is obtained by using the SPC method. In the research conducted, the laboratory quality limits that are sought are Warning Limits and Action Limits, besides that, the factors that affect the value of the analysis of levels and the ability of th e analysis process that have been carried out are also sought. The research data was collected from the trend of chemical data testing for sodium and chloride levels in 2020, the data was then processed using MiniTab 19 software. and chloride : LWL;UWL = 1 53.9; 158.3 mmol/l;. The action limit values obtained for sodium : LAL;UAL = 151.4;159.2 mmol/l and chloride: LAL;UAL = 152.9;159.4 mmol/l. The results of the process capability analysis also found that the running process was less capable and the factor s that influenced the results of the finished product content analysis, which included qualified personnel, validation of analytical methods, product sampling, reagents & standards used and qualifications of instruments. Keywords: SPC, Laboratory Control Limit, v Warning Limit, Action Limit
| Item Type: | Thesis (S1) |
|---|---|
| Call Number CD: | FT/IND 22 009 |
| NIM/NIDN Creators: | 41617310029 |
| Uncontrolled Keywords: | Kata Kunci : SPC, Batas Kendali Laboratorium, iv Warning Limit , Action Limit |
| Subjects: | 600 Technology/Teknologi > 650 Management, Public Relations, Business and Auxiliary Service/Manajemen, Hubungan Masyarakat, Bisnis dan Ilmu yang Berkaitan > 658 General Management/Manajemen Umum > 658.6 Quality Management/Manajemen Kualitas |
| Divisions: | Fakultas Teknik > Teknik Industri |
| Depositing User: | siti maisyaroh |
| Date Deposited: | 21 Dec 2022 07:50 |
| Last Modified: | 21 Dec 2022 07:50 |
| URI: | http://repository.mercubuana.ac.id/id/eprint/72676 |
Actions (login required)
 |
View Item |
