Tablet Rabeprazol Na 20 mg
| No. | Judul |
|---|---|
| 1.0 | DETAIL PRODUK |
| 2.0 | FORMULA PEMBUATAN |
| 3.0 | DAFTAR PERALATAN |
| 4.0 | PENGAWASAN UMUM |
| 5.0 | INSTRUKSI PEMBUATAN |
| 6.0 | DETAIL PROSES PEMBUATAN |
| 6.1 | GRANULASI |
| 6.2 | KOMPRESI |
| 6.3 | PELAPISAN |
| 6.4 | DETAIL MEREK |
1.0 DETAIL PRODUK:
NAMA PRODUK
Rabeprazole Sodium Tablets IP
Deskripsi Produk
Yellow color, round shape, biconvex, enteric-coated tablets having both side plain
KEKUATAN
Rabeprazole 20 mg
Klaim Label
Each enteric-coated tablet contains:
Rabeprazole Sodium IP 20 mg
UKURAN BATCH
5,00,000 Tablets
Rata-rata Berat
232 mg (Uncoated tablets)
255 mg (Enteric-coated tablets)
Umur Simpan
24 months
Penyimpanan
Store in a cool, dry, and dark place below 25 0 C
Kategori Obat
Inhibitor Pompa Proton (PPI)
2.0 FORMULA PEMBUATAN:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Rabeprazole Sodium | IP | API | 20 mg | 5 % | 10.500 kg |
| Magnesium Oxide | USP | Diluent | 155 mg | —- | 77.500 kg |
| Cross Carmillose Sodium | IP | Disintegrant | 12 mg | 6.000 kg | Binder |
| PVPK-90 | IP | Binder | 11.25 mg | —- | 5.625 kg |
| Dichloromethane | USP | Solvent | 0.140 ml | —- | 70.000 liter |
| Talcum | IP | Anti-caking agent | 2 mg | —- | 1.000 kg |
| Cross Carmillose Sodium | IP | Disintegrant | 13.35 mg | —- | 6.675 kg |
| Crospovidone XL | IP | Disintegrant | 10 mg | —- | 5.000 kg |
| Aerosil | IP | Glidant | 1.5 mg | —- | 0.750 kg |
| Calcium Stearate | IP | Anti-adherent | 5.9 mg | —- | 2.950 kg |
3.0 DAFTAR PERALATAN:
Sr. No.
| No. | Mesin/Peralatan | Kapasitas | ID Peralatan |
|---|---|---|---|
| 1. | Weighing Balance | 100 kg | |
| 2. | Vibro Sifter | (with SS Sieves No’s 14,20,30, 40 and 60) | 30” |
| 3. | Mass Mixer with propeller | 100 liter | |
| 4. | Portable Stirrer | ||
| 5. | Tray Dryer | 48 Trays | |
| 6. | Multi-Mill (screen size 2.0 mm) | — | |
| 7. | Double Cone Blender | 200 liter | |
| 8. | Halogen Moisture Balance | — | |
| 9. | Compression Machine | 35 Station | |
| 10. | SS Containers with lid | 100 liter,65 liter | — |
| 11. | Poly-lined HDPE Containers with lid | 30 liter, 45 liter | — |
| 12. | Filter Cloth 100 # | 0.5 Meter | |
| 13. | Polybags | 05 kg,10 kg,20 kg | 4.0 GENERAL PRECAUTIONS: API Description: A white to light yellow, crystalline powder. (Hygroscopic and Light Sensitive) All the Manufacturing Activities shall be performed under controlled conditions (temperature NMT 25 0 C and relative humidity NMT 60 %). When working with Active Ingredients and drug products or a mixture of Active Ingredients and Excipients, wear gloves and a mask to avoid exposure and contact with any body parts. Use Sodium Lamp and Black Poly-bags at every Step. 5.0 MANUFACTURING INSTRUCTIONS: All activities shall be performed as per current SOPs. Take the line clearance of every machine from QA before starting the manufacturing operation from batch to batch and product to product change over. Do not overwrite the entry. In case of mistake, cancel the entry by a single line with sign & date and make a correct entry. |
6.1 GRANULASI:
NOTE: Turn ON the sodium lamp and switch OFF all lights before starting the operation and use black polybags to store the materials.
STEP – I (SIFTING):
Check Sieve Integrity (before sifting and after sifting).
Set the Vibro Sifter (capacity: 30-inch dia) and sieve the Dispensed Materials as per Sieve Sizes mentioned below:
| Nama Bahan | Grade | Kategori | Jumlah per Unit (mg) | Kelebihan (%) | Jumlah Batch (kg) |
|---|---|---|---|---|---|
| Rabeprazole Sodium IP | Dry Mixing | 10.500 kg | 40 # | Magnesium Oxide IP | |
| PVPK-90 IP | Binder | 5.625 kg | 20 # | Dichloromethane USP | |
| Talcum IP | Lubricant | 1.000 kg | 60 # | Croscarmellose Sodium IP | |
| 01 | — | 3. | Filter Cloth 100 # | ||
| 0.5 Meter | — | 4. | Portable Stirrer | ||
| — | — | 5. | SS Containers | ||
| 65 liter (02 No’s) | — | 6. | Poly-lined HDPE Containers with lid | ||
| Should disintegrate within one hour in mixed phosphate buffer pH = 6.8 | — | 8 | Dissolution in Acid Medium (Gastro Resistance) | ||
| Should be dissolved more than 75 % | — | STEP –VII: |
