GOOD MANUFACTURING PRACTICES

Modul-4

Utilities
Wayan Redja

Fakultas Farmasi Universitas Pancasila

Jakarta, 2014

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

1 Primary filter, 30%

2 Secondary filter, 90%
3 HEPA filter, 99,95%
4a Supply air fan
4b Exhaust air fan
6

4b

4a

5 Cooling coil
6 Damper
F Fresh air
E Exhaust air handling
unit (optional filtration)
3

PRODUCTION
FACILITY

E
Exhaust-air handling unit

Recirculation System of AHU

*

Chemical Drier
Desiccant Wheel
Reactivation Air

1 Primary Air Filter

2 Secondary Air Filter
3 HEPA Filter
4 Re-heat Coil
5 Cooling Coil
F Fresh Air
E Exhaust Air
S Supply Air

Reactivation
Air Fan

1
F

+
2

CC

Process Air

Returned Air
Fan

RHC

Supply
Air Fan
S

Supply Air Handling Unit

Low RH
Production Suite

Returned Air
Leakage

Pharmaceutical Production Room

Classification and Requirements
Temp
o
C

Room Classes

RH
%

Qty of particles /
m3
5m

0,5m

AC/
Qty of
Microbe

hr

100

<1

3.5x103

16-25 45-55 3.5x105

>120

2x103

100

20-40

2x104

500

5-20

WA

2 10.000

D
GA

3 100.000

E
F

20-28 30-40

6
3.5x10
20-28 45-75

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

PengoLahan
Awal

Feed
Water

Penghi
langan Ion
Primer
RO

Penghilangan Ion
Sekunder
Continuous
EDI

Mixed
Bed Ion

RO

Ultrafiltrasi

Penukar
Ion
Penukar
Ion

Polishing

Penukar
Ion

Distilasi

Microfiltration
UV Lamp

Pengolahan
Akhir WFI

Distilasi

Penyim
panan &
Distribusi

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.