QUALITY MANAGEMENT

GMP FOR PHARMACEUTICAL PRODUCT (CPOB)

Modul-6
CRITICAL SUPPORTING FACILITIES
Wayan Redja
Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2020
Utilities and Waste Treatment

AHU (Air Handling Unit) or HVAC (Heating

Ventilation and Air-Conditioning) 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 /
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

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.
 ASSIGNMENT
1. What does Critical Supporting Facilitiies mean for Pharmaceutical
industry?
2. What do you know about AHU?
3. Why AHU is needed in GMP for Pharmaceutical Product (CPOB)?
4. What is the function of the important parts of AHU System?
5. Compare the diagram of the Full Fresh Air and the Recirculated Air
AHU Syatem.
6. Explain the difference of those two AHU types.
7. Show in a table the requirements of room classes for production of
pharmaceutical productt.
8. What errors will occur if the AHU System is not functioning well?
9. Write some methods for water treatment in pharmaceutical industry.
10. Draw the diagram of water treatment system by ion exchange
method using deep well water as the feed water and explain how the
system works
Thank you