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Mantu Slide Kuliah 2020 Modul-6
Mantu Slide Kuliah 2020 Modul-6
Modul-6
CRITICAL SUPPORTING FACILITIES
Wayan Redja
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
Utilities and Waste Treatment
Purpose
To protect the quality, efficacy and safety of product, and
to provide comfortable and safe environment for people by
preventing cross-contamination, incorrect temperature,
humidity, air change, flow and pressure.
Introduction of HVAC
How to provide suitable HVAC?
It depends on a number of criteria:
Clean area classification or level of protection
Type of product
Occupancy
Climatic condition and locations.
Location of air terminals and directional air flow
Configuration of the room, air supply, and extract
locations
Clean Area
Purpose
To facilitate production processes in which pharmaceutical
starting materials and products, utensils and equipment are
exposed within the area.
Clean Area
Clean Area Requirements
Some of the basic criteria in creating an effective and efficient clean area:
-CC
6 1 5 4a 2 3
6 4b 3 2 1
E
Exhaust-air handling unit
Recirculation System of AHU
* Chemical Drier 4
Desiccant Wheel Reactivation 1
RHC
Air Fan
E Reactivation Air F
+
Returned Air
Process Air
Fan
5 2 3
Supply
CC
Air Fan
F
● ●
S
Returned Air
Leakage
Pharmaceutical Production Room
Classification and Requirements
Temp RH Qty of particles /
Room Classes o
C m3
% AC/
≥ 5μm ≥0,5μm
Qty of
hr
Microbe
•
A <1 >120
1 100 B 3.5x103 0 5
WA
2 10.000 C 16-25 45-55 3.5x105 2x103 100 20-40
D
GA 3 100.000 E 20-28 30-40
20-28 45-75 3.5x10 2x104 500
6
F 5-20
G Area, BA=Black Area
WA=White Area, GA=Grey
SISTEM PENGOLAHAN AIR / SPA
(WATER TREATMENT SISTEM)
• Distillation
• Ion Exchange
• Reverse Osmoses
• Ultrafiltration
• Deionization
SISTEM PENGOLAHAN AIR / SPA
(WATER TREATMENT SYSTEM)
WHAT?
Water purification to produce Water for Pharmaceutical Use
(WPU) that fulfill the pharmacopoeia specification
for a particular pharmaceutical product.
• Purified Water
Purified drinking water by distillation, ion exchange, reverse osmosis,
or other appropriate process.
• Water for Injection
The highest quality of distilled Purified Water used as an intermediate
or bulk product for injection.
• Highly Purified Water, EP
The highest quality of Purified Water produced by combined methods
of RO, ultrafiltration and deionization
SISTEM PENGOLAHAN AIR / SPA
(WATER TREATMENT SYSTEM)
WHY?
Purified water plays an important and critical role as a
raw material for pharmaceutical products.
Water is good media for microbe, and can dissolve,
absorb, adsorb, suspend many compounds including
poisonous contaminants.
As raw material, purified water is directly used without
prior test.
Microbial test is obtained after the water has been used,
care should be taken for microbiological contamination
and proliferation into the system.
SISTEM PENGOLAHAN AIR / SPA
(WATER TREATMENT SYSTEM)
HOW?
PILIHAN KONSEP DASAR DAN DESAIN SPA
RO Continuous Mixed
Feed EDI Bed Ion
Water
RO Ultra-
filtrasi
Penukar Distilasi
Ion Micro-
filtration
Penukar Penukar
Ion Ion UV Lamp
Distilasi
Feed Water
Drinking Water
Natural Water
- Deep well
- River
- Lake
- Sea
Water Treatment for Drinking Water
(PAM)
Precipitation
Coagulation
Filtration (sand, carbon active)
Softening
Disinfection
Iron removal
Removal of organik /specific
inorganic compounds
WFI
Qualification of
Water Treatment System