DAFTAR ISI

Halaman

HALAMAN SAMPUL................................................................................... i

HALAMAN JUDUL BTF.............................................................................. ii

HALAMAN PERSEMBAHAN .................................................................... ii

KATA PENGANTAR .................................................................................. iii

DAFTAR ISI...................................................................................................

DAFTAR GAMBAR .....................................................................................

DAFTAR TABEL ..........................................................................................

BAB I PENDAHULUAN .............................................................................. 1

1.1. Pendahuluan.......................................................................................... 1

1.2. Tujuan PKPA Industri .......................................................................... 3

1.3. Manfaat PKPA Industri ........................................................................ 3

BAB II TINJAUAN PUSTAKA.................................................................... 5

2.1. Industri Farmasi Dan Industri Obat Tradisional (IOT) ........................ 5

2.1.1. Pengertian Industri Farmasi dan Industri Obat Tradisional........ 7

2.1.2. Izin Usaha Industri Farmasi dan Industri Obat Tradisional........ 6

2.2. Cara Pembuatan Obat Yang Baik ........................................................ 9

2.2.1. Sistem Mutu Industri Farmasi..................................................... 9

2.2.2. Personalia.................................................................................... 10

2.2.3. Bangunan Dan Fasilitas.............................................................. 11

2.2.4. Peralatan...................................................................................... 14

2.2.5. Sanitasi Dan Hygiene.................................................................. 15

2.2.6. Produksi...................................................................................... 15

2.2.7. Cara Menyimpan Dan Pengiriman Obat Yang Baik................... 17

 2.2.8. Pengawasan Mutu....................................................................... 18

2.2.9. Inpeksi Diri, Audit Mutu dan Audit Serta Persetujuan Pemasok 18

2.2.10. PEnggunaan Keluahan Produk dan Penarikan Kembali Produk 19

2.2.11. Dokumentasi............................................................................. 20

2.2.12. Pembuatan dan Analisis Berdasarkan Kontrak......................... 21

2.2.13. Kualifikasi dan Falidasi............................................................ 21

2.2.14. Sampel Pembanding dan Sampel Pertinggal............................ 24

2.3. Cara Pembuatan Obat Tradisional Yang Baik (CPOTB)...................... 25

2.3.1. Manajemen Mutu........................................................................ 26

2.3.2. Personalia.................................................................................... 27

2.3.3. Bangunan, Fasilitas dan Peralatan.............................................. 28

2.3.4. Sanitasi dan Hygiene................................................................... 31

2.3.5. Dokumentasi............................................................................... 32

2.3.6. Produksi...................................................................................... 32

2.3.7. Pengawasan Mutu....................................................................... 33

2.3.8. Pembuatan dan Analisis Berdasarkan Kontrak........................... 34

2.3.9. Cara Penyimpanan dan Pengiriman Obat Tradisional yang Baik 34

2.3.10. Penanganan Keluhan Terhadap Produk , Penarikan Kembali

Produk dan Produk Kembalian................................................. 35

2.3.11. Inspeksi Diri.............................................................................. 36

2.4. Persyaratan Mutu Obat Tradisional...................................................... 37

2.5. Peran Apoteker Di Industri Farmasi..................................................... 38

2.5.1. Apoteker Sebagai Penanggung Jawab Pengawasan Mutu

(Quality Control)........................................................................ 38

2.5.2. Apoteker Sebagai Penanggung Jawab Pemastian Mutu

 (Quality Control)........................................................................ 39

2.5.3. Apoteker Sebagai Penanggung Jawab Produksi......................... 40

2.5.4. Departemen PPIC........................................................................ 40

2.5.5. Quality Management Representative (QMR).............................. 41

2.5.6. Departemen PD & Registrasi...................................................... 41

BAB III RUANG LINGKUP PT BALATIF................................................ 42

3.1. Sejarah PT. Balatif ............................................................................... 42

3.2. Visi dan Misi PT. Balatif ..................................................................... 43

3.2.1. Visi ............................................................................................. 43

3.2.2. Misi ............................................................................................ 43

3.3. Struktur Organisasi ............................................................................... 44

3.4. Layout PT. Balatif ................................................................................ 45

3.5. Sertifikasi, Akreditasi dan Izin PT. Balatif .......................................... 45

3.6. Sarana Produksi .................................................................................... 46

3.7. Jenis Produk ......................................................................................... 47

BAB IV LAPORAN PELAKSANAAN KEGIATAN DAN LAPORAN . .

KHUSUS ………………………………………………………….. 52

4.1. Timeline Pelaksanaan................................................................................ 52

4.2. Tugas Khusus ............................................................................................ 57

4.2.1. Judul Tugas Khusus.......................................................................... 57

4.2.2. Pendahuluan...................................................................................... 57

4.2.3 Tujuan ............................................................................................... 58

4.2.4. Tinjauan Pustaka .............................................................................. 58

4.2.4.1. Tanaman Cengkeh (Syzygium aromaticum L)............................ 58

 4.2.4.2. Kramatograpi Lapis Tipis........................................................... 60

4.2.5. Prosedur Kerja Identifikasi Simplisia .............................................. 61

4.2.5.1. Identifikasi Pemerian.................................................................. 61

4.2.5.2. Identifikasi Makroskopik............................................................ 61

4.2.5.3. Identifikasi Mikroskopik............................................................ 61

4.2.5.4. Identifikasi Uji Kimiawi............................................................. 62

4.2.5.5. Uji Kadar Air.............................................................................. 63

4.2.6. Hasil Pengujian ................................................................................ 63

4.2.6.1. Pemerian..................................................................................... 63

4.2.6.2. Makroskopi................................................................................. 63

4.2.6.3. Kadar Air.................................................................................... 63

4.2.6.4. Pola Kromatografi...................................................................... 64

4.2.7. Pembahasan ..................................................................................... 64

4.2.8. Kesimpulan ...................................................................................... 65

4.2.9. Pustaka ............................................................................................. 65

BAB V KESIMPULAN DAN SARAN ......................................................... 60

5.1. Kesimpulan ......................................................................................... 60

5.2. Saran ................................................................................................... 61

DAFTAR GAMBAR

Halaman

Gambar 2.1 Anatomi jantung manusia........................................................... 8

Gambar 2.2 Gelombang detak jantung........................................................... 18

Gambar 2.3 Sensor Heart Rate....................................................................... 22

Gambar 2.4 Arduino Uno R3......................................................................... 24

Gambar 3.1 Software Arduino IDE .............................................................. 31

Gambar 3.2 Tampilan Software Processing................................................... 32

Gambar 3.3 Sensor Heart Rate....................................................................... 33

Gambar 3.4 Perancangan alat pendeteksi detak jantung................................ 34

Gambar 3.5 Diagram alir proses kerja secara umum..................................... 35

Gambar 3.6 Flowchart timer interrupt........................................................... 36

Gambar 4.1 Mekanisme pengukuran tegangan keluaran Arduino................. 41

Gambar 4.2 Proses compiling pada Arduino IDE.......................................... 42

Gambar 4.3. Komentar ketika Arduino IDE selesai melakukan compiling... 43

Gambar 4.4 Proses compiling dan run........................................................... 44

Gambar 4.5 Proses memilih serial port pada software processing................. 45

Gambar 4.6 Pengujian respon sensor Heart Rate tanpa ada detak jantung.... 46

Gambar 4.7 Pengujian respon sensor Heart Rate terhadap detak jantung..... 47

Gambar 4.8 Pengujian sensor Heart Rate pada ujung jari ............................ 48

Gambar 4.9 Pengujian sensor Heart Rate pada daun telinga ........................ 48

Gambar 4.10 Pengujian alat detak jantung pada kondisi rileks .................... 52

Gambar 4.11 Pengujian alat detak jantung pada kondisi emosi..................... 52

Gambar 4.12 Pengujian alat detak jantung pada kondisi rileks..................... 53

Gambar 4.13 Pengujian alat detak jantung pada kondisi emosi..................... 54

Gambar 4.14 Pengujian alat detak jantung pada konsi rileks......................... 54

Gambar 4.15 Pengujian alat detak jantung pada kondisi emosi..................... 55

Gambar 4.16 Gelombang detak jantung pada kondisi rileks.......................... 58

Gambar 4.16 Gelombang detak jantung pada kondisi emosi......................... 59

 DAFTAR TABEL

Halaman

Tabel 2.1 Spesifikasi Arduino Uno R3.......................................................... 28

Tabel 2.2 Fungsi pada pin power supply........................................................ 30

Tabel 2.3 Fungsi pada pin khusus Arduino Uno............................................ 32

Tabel 2.4 Fungsi pin AREF dan reset Arduino Uno...................................... 33

Tabel 3.1 Fungsi pin sensor Heart Rate......................................................... 39

Tabel 3.2 Hasil pengujian alat pada kondisi rileks dan emosi....................... 45

Tabel 4.1 Hasil pengujian tegangan Aduino.................................................. 48

Tabel 4.2 Hasil pengujian sensor Heart Rate pada objek ujung jari dan daun

telinga ............................................................................................ 56

Tabel 4.3 Hasil pengujian alat pada kondisi rileks ........................................ 63

Tabel 4.4 Hasil pengujian alat pada kondisi emosi ....................................... 64

DAFTAR LISTING

Halaman

Listing 4.1. Rumus perhitungan rata-rata detak jantung pada ujung jari....... 57

Listing 4.2. Rumus perhitungan rata-rata detak jantung pada daun telinga... 57

Listing 4.3. Rumus perhitungan rata-rata selisih ........................................... 57