Escolar Documentos
Profissional Documentos
Cultura Documentos
Sediaan Steril
2019
Kontrak Perkuliahan
A = 80,00 – 100,00
B = 68,00 – 79,00
C = 56,00 – 67,00
D = 45,00 – 55,99
E = 0,00 – 45,00
PRAM-19-STERIL 4
Kualifikasi SISTEM untuk pabrik Farmasi
1. Inorganic compounds
2. Organic compounds
3. Solids
4. Gases
5. Micro-organisms
Kontaminasi Air (2)
Problem mineral :.
Algae
Protozoa
Cryptosporidium
Giardia
Bacteria
Pseudomonas
Gram negative, non-fermenting bacteria
Escherichia coli and coliforms
Turbidity (kekeruhan) dapat disebabkan oleh :
Soft
0-60
Moderate 61-120
Hard 121-180
Check:
1. Nearby septic systems ( kedekatannya dengan system
pembuangan limbah septic )
float
operated excess water recycled activated
carbon
To water
valve from deioniser
air filter sand filter filter softener &
DI plant
spray ball
cartridge
filter
centrifugal pump 5 micrometers
air break to drain
« S” trap to sewer
Water Softener – schematic drawing
"hard" water
in
drain
Proses Pemurnian
dan
PenyulinganAir
Tujuan
1. Filtration
2. Disinfection
4. Distillation or ultra-filtration
Water system design (1)
There should be no dead legs
Tidak boleh ada belokan mati
D
If D=25mm & distance X is
greater than 50mm, we have
a dead leg that is too long. Flow direction arrows
on pipes are important
Deadleg section
X <2D
Sanitary Valve
Water scours deadleg
Water system design (2)
1. Ball valves are unacceptable
1. Sanitary pumps
2. Clamps and O rings
versus threaded fittings
3. Heat exchangers
4. Side arm level measuring devices are
unacceptable (system pengontrol
ketinggian/volume air tidak
dibenarkan)
Skema proses de-ionisasi / reverse osmosis
6 6
5 5
4 4
3 3
2 2
1 1
Water must
be kept Cationic column Anionic column Cartridge Cartridge
circulating filter 5 µm filter 1 µm
Outlets or storage.
Drain line
Second stage reject water goes back to first stage buffer tank
1st stage buffer tank
Branch First stage RO cartridge
1st stage reject concentrate
Branch
Air break
to sewer
Second stage RO cartridge 2nd stage buffer tank
High pressure
pump
Cartridge
filter 1 µm Hygienic pump
Second stage RO water
meets Pharmacopoeia Water returns to 1st stage buffer tank
standards Outlets or storage
Penggunaan reverse osmosis bertujuan untuk :
Water Optional
in-line filter
must be 0,2 µm
kept
circulating UV light
Outlets
Heat Exchanger
Ozone Generator Hygienic pump Air break
to drain
Heat
One of the most reliable methods of disinfection of
water systems
Ozone
Produced easily
Leaves no residue
Disinfection
UV
1. UV does not “sterilize”
2. Flow rate critical
3. Post-irradiation recontamination may be an issue
4. Lamps have finite life
Other chemicals
1. XO2
2. Halogen
3. Formaldehyde
Sampling
1. There must be a sampling procedure
2. Sample integrity must be assured
3. Sampler training
4. Sample point
5. Sample size
6. Sample container
7. Sample label
8. Sample storage and transport
9. Arrival at the laboratory
10. Start of test
Testing - setting specifications for purified water
or WFI
1. Method verification
2. Chemical testing
3. Microbiological testing
test method
types of media used
incubation time and temperature
objectionable and indicator organisms
manufacturer must set specifications
Water for Injections