Proses Produksi

Industri Farmasi
(FA507)

Putriana Rachmawati, M.Si

Kompresi dan Konsolidasi

– Compaction : Situasi dmn material dikenai gaya mekanik

– Compression : Penurunan volume bulk krn adanya displacement fase gas
– Consolidation : peningkatan kekuatan mekanik akibat adanya interaksi antar
partikel
Efek ketika diberikan Gaya

Deformasi Compression Consolidation

• Compressive strain • Reduction bulk • 2 partikel mendekat

• Shear strain volume (50 nm)→ energi
bebas → strong
attractive forces→
cold welding
• Pelelehan padatan
→ fusion bonding →
>kekuatan mekanik
Faktor
1. Chemical nature of the
materials
2. Extent the available
surfaces
3. Presence of the surface
contaminants
4. Intersurfaces distances
Komponen Mesin
Single vs Multiple Punches

Single Multiple

• Small • Produktivitas >

• Mudah dioperasikan
• Odd shape
• Development
• Batch prod kecil
• Dilengkapi dgn tekanan tinggi utk
menurunkan var bobot dgn noise
kecil
• Pengisian serbuk cavity otomatis
• Menurunkan waste of valuable
formulation
• Independent control bobot dan
hardness
 Tipe ‘B’ dan ‘D’

Tipe B Tipe D

• Tablet kecil • Max 25.4 mm

• 9-11 mm
Compaction Process

1. Filling
2. Metering
3. Compression
4. Consolidation
5. Ejection

https://www.pharmapproach.com/tablet-press/
Peningkatan output

1. Peningkatan jumlah punches dan stasion yg efektif

2. Peningkatan kecepatan laju cetak (turrent speed)
Pertimbangan Purchasing
Tablet Compression Tooling
1. Bentuk, ukuran dan tebal dari tablet yang akan dicetak
2. Drawing number of the tablet
3. Press type, model number, jumlah station yang dibutuhkan
4. Type steel
5. Historical data referencing tablets problem spt capping, sticking, picking, high
ejection forces
6. Tablet coating atau tidak
7. Special option
8. Special shipping instruction
Perawatan mesin cetak

1. Matikan mesin ketika batch sudah selesai

2. Bersihkan debu dan granul dengan vakum
3. Lepaskan pressure daru punches
4. Lepaskan feed hopper dan feed shoe
5. Lepaskan upper dan lower punches dan die
6. Bersihkan semua permukaan mesin tablet dan keringkan dengan clean cloth
7. Tutupi permukaan dengan oil
Tablet Coating

1. Utk masking warna, rasa ,bau

2. Proteksi fisik dan kimia
3. Kontrol pelepasan obat dari tablet
4. Proteksi obat dr GIT → enteric coated
5. Inkorporasi obat dan formula adjuvants utk menghindari inkompatibiltas
6. Elegance
Pertimbangkan

Coating
Tablet properties Coating process
composition
• Tahan gesekan • Alat
thd tablet dan • Parameter
mesin coating
• Permukaan halus • Fasilitas dan
kelengkapan alat
• Otomatisasi
proses
 Alat Coating

Standard coating pan Perforated coating pan Fluidized bed coater

• Pan : d 8-60 inches • Perforated drum • Columnar chamber

• Rotasi horizontal berotasi horizontal by the upward flow
• Coating sol → spray • Ribs dip di tablet bed of drying gas
• Diffuser → distribusi → drying air passed
drying air up through and
fluidized the tablet

https://www.youtube.com/watch?v=F0taiI38NXA
https://www.youtube.com/watch?v=SXEduweiViw
https://www.youtube.com/watch?v=QYFe0SAbvH0
 Sugar Coating

Seal coating Subcoating Syrup coating Polishing

• Mencegah • Round the • Cover dan fill in • Beeswax atau

penetrasi edges imperfections warm solution
lembab • Peningkatan of these wax
kedalam tablet ukuran tablet :
inti 50-100%
• Shellac, zein
 Film Coating

Pan variables Process Air Spray variables

• Design/baffling • Kualitas udara • Spray rate

• Speed • Temperature • Derajat atomisasi
• Pan load • Airflow rate • Pola spray
• Nozzle to bed
distance
 Komponen

Film Formers Solvents Plasticizers Colorants

• Nonenteric materials • Air, etanol, methanol, • Flexibility, tensile • Dyes and lakes
• HPMC, Methyl IPA, chloroform, strength, adhesion
Hydroxyethylcellulose, acetone properties
Ethylcellulose, HPC, • Utk melarutkan polimer
Povidone
• Enteric materials
• CAP, Acrylates
Polymers, PVAP