GOOD MANUFACTURING PRACTICES

Modul-3
UTILITIES

Wayan Redja
Fakultas Farmasi Universitas Pancasila
Jakarta, 2014
 Utilities

AHU / HVAC Systems

Production-Room Air Conditions Requirements
Water for Pharmaceutical Use
Water Treatment Installation
 AHU / HVAC Systems

General Principles
Purpose
Full Fresh-Air System
Recirculation System
Fresh Air and Recirculation System
Room Environment Requirements
Commissioning, Qualification and
Maintenance
 AHU / HVAC Systems
Air Handling Unit or Heating Ventilation and Air Conditioning
is a system to control air condition and air movement within a facility to
fulfill the required specifications.

General Principles
No failure of supply air, return air, exhaust air and extract system fan.

Alarm systems should be provided for critical air fan fails.

Depends on the locations and climatic conditions, additional

components (fresh air frost coil or pre-cooling coil on fresh air inlets;
eliminators of: snow, dust, or moisture).

Two basic concepts of air delivery systems: full fresh air and
recirculation systems.
 AHU / HVAC Systems

Purpose
To control required air condition: temperature, humidity, particles,
microbes, and air change per hour.
To provide comfortable conditions for operators.
To protect product from contamination, cross-contamination, incorrect
temperature and humidity
To protect personnel from dust, fume and unacceptable comfort
conditions
To protect environment from dust, fumes and effluent discharge.
To prevent: cross-contamination, degradation products, health hazard,
pollution of environment.
 AHU / HVAC Systems
Full Fresh Air System
The full fresh air system is used in a facility for toxic products.

Energy recovery wheels may be used in single-product facilities.

The leakage between the supply and the exhaust air systems as it
passes through the wheel should be prevented.

Energy recovery wheels should not be used in multiproduct facilities,

plate or water-coil heat exchanger may be used.

The exhaust air system operates at a lower pressure than the supply
system.

The required degree of filtration of the exhaust air depends on the air
contaminants and local environmental regulations.
 AHU / HVAC Systems for Solid Dosage Forms
Full Fresh Air System for Single Product Facility (WHO 2007, p.94)

*
*ERW .
is not required for Supply air-handling unit
multiproduct facilities
& exhaust air handling - +
is optional Supply
Air

Fresh PF CC HC BF SF HF S
Air DP 40% 85% 99.95%

F
*RW
Production
Facility
E
*Exhaust air-handling unit
Exhaust DP EF
Air

HF SF PF
** CCCooling Coil HPHeating Coil
DPDamper PFPrimary Filter SFSecondary Filter HFHEPA Filter,H13 BFBlower EFExhaust Fan ERW Energy Recovery
Wheel
 AHU / HVAC Systems
Recirculation System
No risk of contamination or cross-contamination (including fumes and
volatiles) occurs due to recirculation of air.

Air containing dust from highly toxic processes should never be re-
circulated to HVAC system.

HEPA filters (H13, 99.95%)* are installed in the supply air stream.

HEPA filters may be located in the air-handling unit or placed

terminally.

HEPA filters may not required for single-product facility with no

evidence of cross-contamination.
Secondary packaging facility may not require HEPA filters.

* WHO 2007, Comparison of filter test standards, in QA of pharmaceuticals p.72

TYPICAL AHU FOR SINGLE PRODUCT FACILITY WITHOUT EXHAUST FILTRATON

OUTSIDE AIR
BLOWER / \ / \ DAMPER

SUCTION AIR \ / \ / COARSE FILTER

40% EFFICIENCY
EXHAUST AIR
/
\
RETURN AIR /
\

PREFILTER
85% EFFICIENCY
ROOM
COOLING COIL
PARAMETERS are:
- TEMPERATURE
- HUMIDITY HEATING COIL
- ROOM CLASS
- ROOM PRESSURE
- SUPPLY AIR VOLUME BLOWER
- RETURN AIR VOLUME
- SUCTION AIR VOLUME
- OUTSIDE AIR VOLUME FINE FILTER
95% EFFICIENCY
/ \ / \
SUPPLY AIR
HEPA FILTER* (Class 1)
*For Class 3, not necessary # For separate full fresh air and reciculation
systems (see WHO 2007, p.92-93)
 SCHEMATIC DIAGRAM OF AHU

2 4

Outside Air

5 6 5
1 CLASS 10.000 CLASS 100.000 DIRTY ROOM
White Grey Black

Note:

= Out side Air 1 Air Handling Unit (AHU) 4 Supply Air Diffuser
= Supply Air 2 Hepa Filter (Eff.99,99%) 5 Return Air Grille
= Return Air
3 Medium Filter (Eff:95%) 6 Air Shower
= Exfiltration / Infiltration

WR-10-QM
Production-Room Air Conditions Requirements @ ASEAN # BS 5295 * US Fed. Std. 209E ** EC, BPOM

Max. Qty of Max.

Rh Particles/m3 Filter Air
Room Temp Qty of
AC Change Notes
Class (OC) (%) ≥ 0,5 m ≥ 5 m Microbe/ Effic. per hour
m3
White/I @ • Aseptic/Sterile zone
IA, IB # • A = Under LAF
<1 (A) >120 (A)
100* + 99,997 • B = Supporting zone
16-25 45-55 3.5x103 0 5 (B) 20-40 (B)
A, B** • Weighing, Dissolving
• Filling

White/II @
2# • Sterile zone
+ 16-25 45-55 3.5x105 2x103 100 99,995 20-40
10.000* • Filtration
C**
Grey /III @
16-25a 45-55a 20-40a a Clean room.
3#
+ 20-28b 30-40b 3.5x106 2x104 500 95 5 –20b b Hygroscopic subst.
100.000*
20-28c 45-75c 5 –20c c General.
D E F**
- -15-0 - - - - - -  Freezer.
- 0-5 45-75 - - - - -  Cold room.
+ 5-15 45-75 - - - - -  Cool room.
+ 20-28 45-75 - - - 80-85 -  Warehouse.
Black/IV@
+ 20-28 60-80 - - - 30-40 5-20  Second. Packaging.
G**
 20-28 60-80 - - - 30-40 5-20  Lab, canteen, toilet,
clean locker, rest room.
- - - - - - - -  Quarantine area, workshop,
changing room. WR-11-QM
Production-Room Air Conditions Requirements
 Water for Pharmaceutical Use
Water Quality Specifications
Drinking water / Potable water
Purified water
Highly purified water
Water for injections

Water Purification Methods

Filtration
Ion-exchange
Ultrafiltration and/or reverse osmoses
Distillatiom
Water Treatment Installation

WR-14-QM