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
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
≥ 0,5μm ≥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

WFI