Designing a large-scale GMP production facility for biological production requires
various types of risk assessments to be carried out. This is the main tool in obtaining a
balance between the aspects where GMP and biosafety guidelines contradict each other. Only
by evaluating the various risks involved in the project, can rational and optimal choices
be made regarding facility design and construction.
References
1.
American Society of Mechanical
Engineers. (1997). Bioprocessing Equipment. New York: ASME.
2.
ColeG.
C., (1990). Pharmaceutical
production facilities. Design and Applications (2nd ed.),
Ellis Norwood.
3.
DS/ENV 1631. Clean Room Technology—Design,
Construction and Operation of Clean Rooms and Clean Air Devices. Brussels: European Commission for
Standardization.
4.
DS/EN 29001 Quality Systems—Model for
Quality Assurance in Design/Development, Production, Installation and
Servicing. Brussels: European
Commission for Standardization.
5.
DS/EN 29002 Quality Systems—Model for
Quality Assurance in Production and Installation. Brussels: European Commission for
Standardization.
European Commission. (2006). Compilation of Community Procedures on Inspections and
Exchange of Information. London: European Medicines Agency. Available at: www.emea.europa.eu/Inspections/docs/335103en.doc
LjungqvistB., ReinmüllerB. (1996). Clean room design: Minimizing Contamination Through Proper
Design. Buffalo Grove, IL: Interpharm Press Inc.
13.
NFPA 318. (1998).
Standard for the Protection of Clean Rooms. Quincy,
MA: NFPA.
14.
OdumJ.
N., (1997). Sterile Product
Facility Design and Project Management. Buffalo Grove,
IL: Interpharm Press
Inc.
15.
The Rules Governing Medicinal Products in the European Community, Volume IV: Good Manufacturing Practice for Medicinal Products, Brussels.
16.
WhyteW., (Ed.). (1991). Clean Room Design. Chichester,
England: John Wiley and
Sons.
17.
Agriculture & Agri-Food Canada Publication No. 1921/E. (1996). Containment Standards for Veterinary
Facilities (1st ed.). (The Red
Book).
18.
Ashrae Handbook. (1999). Heating, ventilating and air-conditioning
applications.
19.
BossM. J., DayD. W., (Eds.). (2003). Biological Risk Engineering Handbook: Infection
Control and Decontamination. CRC
Press.
20.
CraneJ. T., RichmondJ. Y., (2006). Design of Biomedical Laboratory
Facilities. In FlemingD. O., HuntD. (Eds.).
Biological Safety: Principles and Practices (4th
ed.), pp. 273–294. Washington,
DC: ASM Press.
21.
Doblhoff-DierO., StaceyG. (2006). Cell Lines: Applications and
Biosafety. In FlemingD. O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (4th
ed.), pp. 221–241. Washington,
DC: ASM Press.
22.
DS/EN 1620. Biotechnology—Large-scale Process and Production—Plant Building According to the Degree of Hazard.
23.
DS/EN 12128. Biotechnology—Laboratories for
Research, Development and Analysis—Containment Levels of Microbiology Laboratories,
Areas of risk, Localities and Physical Safety Requirements.
24.
DS/EN 12307. Biotechnology—Large-scale
Process and Production—Guidance for Good Practice, Procedures, Training and Control for
Personnel.
25.
DS/EN 12460. Biotechnology—Large-scale
Process and Production—Guidance on Equipment Selection and Installation in Accordance
with the Biological Risk.
26.
DS/EN 12461. Biotechnology—Large-scale
Processes and Production—Guidance for the Handling, Inactivation and Testing of
Waste.
27.
DuaneE. G., FinkR. C., (2006). Primary Barriers and Equipment-Associated
Hazards. In FlemingD. O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (4th
ed.), pp. 295–302. Washington,
DC: ASM Press.
28.
FlemingD.
O., (2006). Risk
Assessment of Biological Hazards. In FlemingD.
O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (4th
ed.), pp. 81–92. Washington,
DC: ASM Press.
29.
Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines). (1998).
30.
Health Canada. (2004).
The Laboratory Biosafety Guidelines (3rd ed.). (The Peach Book).
RichmondJ.
Y., (Ed.). (2005). Anthology of
Biosafety VIII: Evolving Issues in Biosafety. Mundelein,
IL: ABSA.
38.
RichmondJ. Y., McKinneyR. W., (Eds.). (1999). Biosafety in Microbiological and Biomedical
Laboratories, Public Health Service (4th ed.).
U.S. Department of Health and Human Services, Government Printing
Office, Washington, DC.
39.
RichmondJ. Y., McKinneyR. W., (Eds.). (2000). Primary Containment for Biohazards: Selection,
Installation and Use of Biological Safety Cabinets (2nd
ed.). U.S. Department of Health and Human Services, Government
Printing Office, Washington,
DC.
40.
U.S. Department of Health and Human
Services. (2007). Biosafety in Microbiological and
Biomedical Laboratories (BMBL) (5th ed.).
Government Printing Office, Washington,
DC.
41.
World Health Organization. (1993). Laboratory Biosafety Manual (2nd
ed.). Geneva, Switzerland: World Health Organization.
42.
World Health Organization. (1995). Biosafety Guidelines for Personnel Engaged in the
Production of Vaccines and Biological Products for Medical Use. Geneva, Switzerland: World Health
Organization.
43.
World Health Organization. (1999). Global Action Plan for Laboratory Containment of Wild
Polioviruses. Geneva, Switzerland: World Health Organization.
44.
World Health Organization. (2002). Vaccines and Biologicals. Report of the Seventh Meeting of
the Technical Consultative Group (TCG) on the Global Eradication of Polio. Geneva, Switzerland: World Health
Organization. Available at: www.polioeradication.org/content/publications/TCG7report.pdf
45.
World Health Organization. (2003). Guidelines for the Safe Production and Quality Control of
IPV Manufactured from Wild Polio Viruses. WHO Technical report (in press). Geneva, Switzerland: World Health
Organization.
46.
CiprianoM.
L., (2000). Biosafety
Considerations for Large-scale Production of Microorganisms. In FlemingD.
O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (3rd
ed.), pp. 541–555. Washington,
DC: ASM Press.
47.
CiprianoM.
L., (2006). Large-Scale
Production of Microorganisms. In FlemingD.
O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (4th
ed.), pp. 561–579. Washington,
DC: ASM Press.
48.
DamnP.
G., (1990). The Biological
Production Facility—Design for Protection of the Worker and the
Community. Bioprocessing Safety: Worker and Community Safety and
Health Considerations. ASTM STP 1051, HyerW.
C.Jr. (Ed.), pp. 58–64. Philadelphia: American Society for Testing and
Materials.
49.
ElliottL. J., HalperinW. E., LandriganP.
J., (1990). Perspectives
on Opportunities Toward a Hazard-Free Bioprocessing Environment. Bioprocessing Safety: Worker and Community Safety and Health
Considerations. ASTM STP 1051, HyerW.
C.Jr, (Ed.), pp. 20–26. Philadelphia: American Society for Testing and
Materials.
50.
FoglesongM.
A., (1990). Safety in
Bioprocessing: An Industrial Perspective. Bioprocessing Safety:
Worker and Community Safety and Health Considerations. ASTM STP 1051, HyerW.
C.Jr, (Ed.), pp. 14–19. Philadelphia: American Society for Testing and
Materials.
51.
GeogheganR. F., MaslarH. W., (1991). Biowaste treatment. Journal
of Parental Science & Technology, 45(5), 224–228.
52.
Halkjær-KnudsenV. (2002). The polio facility at SSI in Denmark. GMP and
Containment. In RichmondJ.
Y. (Ed.). Anthology of Biosafety V: BSL-4
Laboratories, pp. 167–178. Mundelein, IL: ABSA.
53.
Halkjær-KnudsenV. (2005). Design considerations for large-scale production of
biologicals: GMP and containment synergies. In RichmondJ.
Y. (Ed.). Anthology of Biosafety VIII:
Evolving Issues in Biosafety, pp. 39–67. Mundelein, IL: ABSA.
54.
Halkjær-KnudsenV. (2005). Facility design considerations for large-scale
production of biologicals: GMP and Containment Synergies. European Journal of Parenteral & Pharmaceutical Sciences, 10(2), 35–42.
55.
KearnsM.
J., (1989). Containment
of Biological Hazards: Effect of Guidelines on the Design of Pharmaceutical Facilities
and Process Equipment. Pharmaceutical Engineering, 9(4), 17–21.
56.
KeeneJ.
H., (1990). Industrial Safety
for the Biotechnology Industry. Bioprocessing Safety: Worker and Community Safety and
Health Considerations. ASTM STP 1051, HyerW.
C.Jr., (Ed.), pp. 77–82. Philadelphia: American Society for Testing and
Materials.
57.
MartinezK. F., ElliotL. J., JonesJ. H., (1990). General Considerations for Work Practices and Personal
Protective Equipment in Biochemistry Industries. Bioprocessing Safety: Worker and
Community Safety and Health Considerations. ASTM STP 1051, HyerW.
C.Jr. (Ed.), pp. 83–90. Philadelphia: American Society for Testing and
Materials.
58.
MeechanP. J., GyurisJ., PetuchB. R., ChartrainM. M., HerberW. K., (2006). Biosafety in the Pharmaceutical
Industry. In FlemingD. O., HuntD. L. (Eds.). Biological Safety: Principles and Practices (4th
ed.), pp. 551–560. Washington,
DC: ASM Press.
59.
PaulE.
L., (1990). Design Criteria for
Safety in the Isolation and Purification of Antibiotics and Biologically Active
Compounds. Bioprocessing Safety: Worker and Community Safety and Health
Considerations. ASTM STP 1051, HyerW.
C.Jr. (Ed.), pp. 63–73. Philadelphia: American Society for Testing and
Materials.
60.
VranchS.
P., (1990). Containment and
Regulations for Safe Biotechnology. Bioprocessing Safety: Worker and Community Safety
and Health Considerations. ASTM STP 1051, HyerW.
C.Jr. (Ed.), pp. 39–57. Philadelphia: American Society for Testing and
Materials.
