Rancangan Obat Injeksi

ProHyo-20
(HYOSCINE BUTYLBROMIDE INJECTION
20MG/ML)
Oleh:
PT. Nama Anda
Profil Singkat Produk
• Kajian Farmakologi
• Kelas terapi
• Indikasi
• Bentuk dan Kekuatan, Rute pemberian
• Dosis
• Lama pemakaian
• Efek samping, kontraindikasi, perhatian
• Farmakokinetika
• Farmakodinamika
Profil Singkat Produk
• Preformulasi
• Sifat fisika
• Sifat Kimia
• Sifat fisikokimia
• Stabilitas
• Produksi
• Rancangan formula 1 batch (10 ribu – 1 juta)
• Prosedur pembuatan
• IPC
• QC/ QA
• Pengujian mutu
• Batch sheet
Hyoscine Butylbromide Injection (Contoh)
Manufacturing Directions (terjemahkan)
1. Preparation of water. Check item 2 to be used for solution
preparation and verify that it meets conductivity limit of NMT
1 mS/cm and pH range of 5 to 7.
2. Preparation of solution.
a. Put 900 mL of item 2 into the preparation vessel and bubble N2 gas
(item 4) to expel dissolved O2 gas. Monitor the O2 sensor display
(O2% limit = NMT 1).
b. Add and dissolve item 1 into step 2-a preparation ves-sel. Mix well
with stirring to make clear solution.
c. Check pH (range 4.0–5.2).
d. Adjust pH if necessary with item 3 (range 4.0–5.2).
e. After adjustment of pH, make up volume to 1 L by item 2 and mix
during bubbling item 4 until oxygen%is less than 1.
f. Check final pH (range 4.0–5.2).
g. Take sample for assay.
3. 3. Preparation of ampoules. Use type I 2-mL clear glass am-
poules, USP. Sterilize the ampoules by using dry heat tunnel.
4. parameters: sterilization temperature 21.1◦C and exposure
time 20 minutes.
Preparation of filtration assembly and machine parts for production.
Clean and sterilize filtration assembly and ma-chine parts by autoclaving.
1. Prefiltration.
a. Before starting the filtration, check the integrity of filtercartridge.
b. Integrity test results of filter cartridge.
c. Transfer the solution from the preparation vessel to mobile vessel through
filtration assembly, containing a 0.45-mm filter cartridge.
d. After filtration, transfer mobile vessel to solution room.
6. Final filtration.
e.Before starting the final filtration, check the integrity of filter cartridge.
f. Aseptically connect the N2 line through sterile N2 filter to the inlet of vessel.
g.Aseptically connect one end of the previously steril- ized filtration assembly with
0.22-mm pore-size filtra-tion cartridge to the outlet of vessel and the other end
to the buffer holding tank on the ampoule’s filling ma-chine parts.
h.d. Filter the solution.
2. 7septic filling. Fill 1.10 mL (range 1.05–1.15 mL) solution from the bulk
into each sterile dry clean ampoule and seal it.
3. 8. Terminal sterilization and leak test. Load the inverted ampoules
inside the autoclave chamber and run the cy-cle as per following
4. 9. Optical checking. Check the ampoules under optical checking
machine
Keterangan
• Setiap mahasiswa mengerjakan 1 sediaan (coordinator mengatur agar
tidak ada yang duplikasi)
• Formula dicari di buku referensi : Handbook of Pharmaceutical
Manufacturing Formulations Sterile Products
• Dibuat dalam slide di ppt, setiap coordinator menggabung
• Dapat dilengkapi produk yang ada dipasaran, keunggulan produk kita,
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