:

ISE: International Society for Pharmaceutical Engineering

HVAC: Heating, Ventilation and Air Conditioning
WHO: World Health Organization
ICH: International Conference on Harmonization
ISO: International Standards Organization
PIC/S: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme
ASHRAE: American Society of Heating, Refrigeration and Air Conditioning
Engineers
ASTM: American Society for Testing and Materials
FDA: US Food and Drug Administration
GEP: Good Engineering Practice
GMP: Good Manufacturing Practice
: -1
: -1-1
( HVAC)
.

.
HVAC
HVAC .
. GEP GMP

 -2-1:
ISP Baseline Guides For Facilities
:
Volume 1 Active Pharmaceutical Ingredients, Second Edition, April 2007
Volume 2 Oral Solid Dosage Forms, First Edition, February 1998
Volume 3 Sterile Manufacturing Facilities, First Edition, January 1999
Volume 4 Water and Steam Systems, First Edition, January 2001
Volume 5 Commissioning and Qualification, First Edition, March 2001
Volume 6 Biopharmaceutical Manufacturing Facilities, First Edition, June 2004
HVAC
. ) (DP
.
ISPE HVAC
Community of Practice ISPE HVAC COP .
-3-1 :
ISPE HVAC :
-

HVAC ISPE Baseline

Guides .
HVAC . HVAC :





FDA
.

:
World Health Organization (WHO)
International Conference on Harmonization (ICH)
International Standards Organization (ISO)
Institute of Environmental Sciences and Technology (IEST)
European Medicines Agency (EMEA)
US Food and Drug Administration (FDA)
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S)
American Society of Heating, Refrigeration and Air Conditioning Engineers
(ASHRAE)
International Society for Pharmaceutical Engineering (ISPE)
American Society for Testing and Materials (ASTM) International
Chartered Institute of Building Service Engineers (CIBSE, UK)
American Council of Government Industrial Hygienists

) Instrumentation, Systems, and Automation Society (ISA

Sheet Metal and Air Conditioning Contractors National Association (SMACNA
))(North America
)) National Environmental Balancing Bureau (NEBB (US
) Heating and Ventilating Contractors Association (HVCA) (UK
4-1:
HVAC GMP
:
HVAC

HVAC ISPE Baseline
Guides .
HVAC

HVAC
.
.
HVAC
HVAC
.
-5-1 :
HVAC .
- HVAC .

 ISPE Baseline Guides HVAC FDA .EMEA

FDA EMEA:
HVAC .
.
-6-1 :
.
HVAC 1 3
.
.
-1-6-1:

." " :

.
.
.
2-6-1 :
HVAC
) (Hazardous .
.

 .
.
3-6-1 :

) .(21CFR PART 211

. ) (AMBIENT AIR
.
4-6-1 :
100000 0,3
.
.
.
5-6-1 :
1 .
.
6-6-1 :

.
.
. ) )( GRADE (EAMEA
.
7 10 ) 7 0,5 352 (
10 . 7 EUROPEAN B A B C
EUROPEAN D AT REST .

)(CNC

)
(

Grade 8

Grade 7

Grade
5

ISPE

3,520,000

352,000

3,520

3,520

0.5

29,000

2,900

29

20
(ISO
) 4.8

3,520,000

352,000

3,520

0.5

29,000

2,900

20

200

100

10

ISPE

ISO 8
)
(100,000

ISO 7
)
(10,000

ISO 5
)
(100

100

10

3
) ( CFU/m

0.5

action level
3
) ( CFU/m

AT REST

IN
OPERATION

IN
OPERATION

European commission EU
GMP, annex 1 Vol. IV,
Manufacture of sterile
medicinal products ( effective
1 march 2009)( similar to
)PIC/S GMP annex 1 2007

FDA, October 2004, Guidance

for industry Sterile Drug
Products Produced by Aseptic
Processing

:
US European .
US IN OPERATION
AT REST .
US EU Grade D CNC
ISPE .
) ( EU Grade D .
)
API) ( API ) API
((intermediates