KEAMANAN BIOLOGI

(BIOSAFETY)

Safety in the Microbiology Lab

Pengampu:
Prof.Dr.Ir. Sebastian Margino
Prof.Dr.Ir. Erni Martani
Dr.Ir. Ngadiman, M.Si.
Biosafety – what is it,
who takes care of it?

Ensuring we can benefit from the technology

by minimizing the risks technology.

 Biotechnology is not the first technology to raise concerns.

 Consider : cars, aeroplanes, drugs, electricity, pesticides, etc.
 All have risks and benefits
 They are regulated to allow us access to the benefits.
Introduction
Microbiological laboratories are special, often unique
work environments that may pose identifiable
infectious disease risks to person in or near them .
Infections have been contracted in the laboratory
throughout the history of microbiology.
Although some reports suggest that laboratory personnel were
at increased risk of being infected by the agents they handle,
actual rates of infection are typically not available.
However, the studies of Harrington and Shannon and of
Skinhoj, indicate that laboratory personnel had higher rates of
Tuberculosis, shigellosis, and hepatitis B than does the general
topulation.
Bacterial Laboratory Acquired Infections

• 76% of exposures occurred in clinical labs;

6% in vaccine manufacturing facilities; 8%
in research labs.
• Exposure modes: 60% inhalation, other
exposure modes included ingestion
(intentional, poor technique such as mouth
pipetting, smoking and eating in the lab)
and secondary transmission.
 Terminology
• Biosafety focuses on reducing exposure to
and release of biological materials risks.
• Biosecurity refers to ensuring the security of
biological materials to prevent theft, illicit
use or release.
• Bioterrorism : the use of bioscience facilities
as sources of biological weapons material
(viable and virulent pathogens)
 Bioterrorism Issues
– This is the big worry of the national
security
– Easier to manage because it is treatable
and contagious
– Hard because it could be a lot of people

Ideal characteristics of
biological weapons are high
infectivity, high potency,
availability of vaccines, and
delivery as an aerosol.
Smallpox Bioterrorism
• Stable aerosol virus
• Easy to produce
• Infectious at low doses
• Human to human
transmission
• 10 to 12 day incubation
period
• Up to 30% mortality rate
 HUMAN/PUBLIC HEALTH ?
• CHEMICAL HAZARD • BIOLOGICAL HAZARD
– effects immediate – effects delayed and not
and obvious obvious
– victims localized by – victims dispersed in time
time and place and place
– first responders are – no first responders
police, fire,etc – Attack identified by
medical and public
health personnel
CHEMICAL HAZARD - PUBLIC HEALTH

• Tokyo subway 1995 / Sarin

–Effects within minutes
–Victims self-reported to authorities,
self- transported to hospitals
–First responders
- fire, police
- Agent identified: 3 hrs
–Event over: 12-24 hrs
 BIOHAZARD - PUBLIC HEALTH
• Examples of biological assaults:
note: all incidents were discovered by public health officials
and initially presented as an unusual cluster in time and place
of an uncommon disease
– 1996 Shigella dysenteriae USA
– 1984 Salmonella USA
– 1970 Ascaris suum Canada
– 1966 Typhoid Japan
– 1965 Hepatitis USA
 Biohazardous Material
• Infectious • Human and non-human
microorganisms primate cells, cell
(bacteria, viruses, fungi, culture (primary and
parasites, prions, immortalized), tissues,
rickettsiae, etc.) affecting blood (whole blood or
humans and animals any components) and
• Diagnostic (clinical) body fluids
specimens • Animal or plant cells,
• Recombinant DNA (viral cell cultures, fluids,
vectors, gene therapy, tissues or derived
cloning) wastes which may
• Genetically Modified contain pathogens
Microorganisms • Animals known to be
(transgenic plants and reservoirs of zoonotic
animals) disease
 Reason for biosafety assessment
 The products of biotechnology are living both natural and
genetically modified organisms (GMOs)
 GMOs are confined
 Like other crops, livestock etc, living GMOs can replicate
in the environment
 Thus, before release, an assessment of their impact on
health and the environment is undertaken = BIOSAFETY

What issues are considered in the risk assessment?

Fall into 5 categories :
1. Environmental
2. Human health
3. Food and feed safety
4. Economic
5. Social
Biohazard Management
The management of biohazards through
the proper application of engineered
containment and administrative
controls is referred to as biosafety or
biohazard control

Biosafety or biohazard control is a team

effort involving the PI, research lab
personnel, institution, government
 Attention:
• Laboratory safety rules will be strictly
enforced.
• If you have any questions related to
safety, do not hesitate to ask.
• Please read all materials related to
safety.
• Make every effort to prevent lab
accidents and promote safety to insure
that labs will be an enjoyable
experience for all.
 TARGET OF BIOSAFETY

• PROTECT YOURSELF
• PROTECT YOUR CLASSMATES
• PROTECT YOUR FAMILY
• PROTECT YOUR NATION
The following rules must be adhered to:

• KEEP LAB BENCH ORDERLY.

• USE PERSONAL PROTECTIVE
EQUIPMENT PROPERLY.
• HAND WASHING.
• PERSONAL HYGIENE.
• DISCARD BIOHAZARD WASTE
CORRECTLY.
Abbreviations
• BSC – Biosafety Cabinet
• BSL – Biosafety Level
• ABSL – Animal Biosafety Level
• BSO – Biosafety Officer
• BUA – Biological Use Authorization
• CDC – Center for Disease Control
and Prevention
• DGR – Dangerous Goods
Regulations
• DOT – Department of Transportation
• EHS – Environmental Health and
Safety
• EPA – Environmental Protection
Agency
• HMR – Hazardous Materials
Regulations
• GMO/M – Genetically Modified
Organism/Microorganism
• IACUC – Institutional Animal Care
and Use Committee
• IATA – International Air Transport
Association
• IBC – Institutional Biosafety
Committee
• IRB – Institutional Review Board
• NIH – National Institute of Health
• OSHA – Occupational Health and
Safety Administration
• PI – Principal Investigator
• PP – Physical Plant
• PPE – Personal Protective
Equipment
• PS – Pubic Safety
• USPS – U.S. Postal Service
• QA – Quality Assurance
 SILABUS
(Cakupan Materi)
Mg Ke Materi Pengampu
I Pengantar Ngadiman
II Biohazard St. Margino

III Mobile DNA St. Margino

IV GMO/Ms St. Margino
V Prinsip2 Biosafety St. Margino
VI Klasifikasi Lab. Ngadiman
VII Ujian Sisipan Material II-V
VIII Jaminan Mutu Lab. Ngadiman
Mg Ke Materi Pengampu
IX Good Lab. Practices Erni Martani
X Manajemen Keam.Lab. Erni Martani

XI Managmen Limbah Erni Martani

XII Biosafety Protocol Ngadiman

XIII Regulsai Biosafety Ina Erni Martani

XIV Pengujian Keam. PRG Erni Martani

XV Bioethic Ngadiman

XVI Seminar Mahasiswa Ngadiman

XVII Ujian Akhir Materi VII-XVI
 Referensi
1. A. Hadi. 2000. Sistem managemen mutu laboratorium.
2. KLH.2005. PP no 21 Tahun 2005 ttg Keamanan Hayati
PRG
3. S.B. Levy and R.V. Miller. 1989. Gene transfer in the
environment.
4. C.B. et al (Ed.). 2002. Cartagena protocol on
Biosafety.
5. DepTan. 1998. Pengujian keamanan hayati PRG.
6. DepKes. 1993. Pedoman keamanan lab. mikrobiol.
dan biomedik.
7. WHO. 2004. Laboratory safety manual.
8. Internet
See You !!