GOOD MANUFACTURING PRACTICES

Modul-4

Utilities
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2014
AHU (Air Handling Unit) or HVAC (Heating
Ventilation and Air-Conditioning)
Utilities and Waste Treatment Systems
Water Treatment for Pharmaceutical Use
 AHU / HVAC SYSTEMS

Introduction of HVAC
Clean Area
Protection of Personnel, Product and Environment
HVAC Systems
Commissioning, Qualification, and Maintenance
 Introduction of HVAC
Definition
HVAC (Heat, Ventilation and Air Conditioning) or AHU (Air
Handling Unit) is a system serves to control the condition of air
(i.e. temperature, RH ,microbe, air change) and provide the
required air flow (pressure) within a particular facility

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
Clean Area (Clean Room)
An area (or room) with defined environmental control of
particulate and microbial contamination, constructed and used in
such a way to reduce the introduction, generation and retention of
contaminants within the 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:

Building finishes and structure

Room pressure
•
Location of air terminals and
directional air flow
Air filtration, air change or flushing rate
Temperature and humidity
Material flow, personnel flow
Equipment movement
Process being carried out, and type of product
Occupancy
Outside air conditions
 Full Fresh-Air System AHU

-CC
6 1 5 4a 2 3

1 Primary filter, 30% 5 Cooling coil

2 Secondary filter, 90% 6 Damper PRODUCTION
3 HEPA filter, 99,95% F Fresh air FACILITY
4a Supply air fan E Exhaust air handling
4b Exhaust air fan unit (optional filtration)

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

1 1 Primary Air Filter

-
2 Secondary Air Filter Supply Air Handling Unit
3 HEPA Filter
4 Re-heat Coil Low RH
5 Cooling Coil Production Suite
F Fresh Air
E Exhaust Air
S Supply Air

Returned Air
Leakage
 Pharmaceutical Production Room
Classification and Requirements
Temp RH Qty of particles /
oC m3 AC/
Room Classes % Qty of
hr
≥ 5μm ≥0,5μm Microbe

A <1 >120
1 100 3.5x103 0
B 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
3.5x106 2x104 500 5-20
F 20-28 45-75
G
BA 4
H

WA=White Area, GA=Grey Area, BA=Black Area

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

Pengo- Penghi Penghi- Pengo- Penyim

Lahan langan Ion langan Ion Polishing lahan panan &
Awal Primer Sekunder Akhir WFI Distri-
busi

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

 Design Qualification (DQ)

 Installation Qualification (IQ)
 Operational Qualification (OQ)
 Performance Qualification (PQ)
- Phase-1 (2-4 weeks): Approval of procedures, specification,
demonstration of purified water production and distribution,
chemical and microbiological testing
- Phase-2 (2-4 weeks); Consistent operational parameter,
consistent quality and quantity of product. Water quality fulfill
requirements.
- Phase-3 (12 months): Demonstrate system reliability.