BIOSAFETY &

BIOSECURITY
PBMI-2021
Biosafety dan biosecurity merupakan dua hal yang saling berkaitan.
Keduanya mempunyai tujuan untuk menjamin keamanan dari bahaya biologis.
Tetapi meski tujuannya sama kedua konsep ini merupakan dua hal yang berbeda.

biosecurity dapat diartikan sebagai tindakan perlindungan, pengendalian dan

akuntabilitas mikroorganisme berbahaya yang berada di dalam laboratorium atau
penyalahgunaan bahan/mikroorganisme berbahaya tersebut.

Biosecurity juga dapat diartikan sebagai usaha untuk menjaga suatu daerah dari
masuknya agen penyakit, menjaga tersebarnya agen penyakit dari daerah tertentu, dan
menjaga agar suatu penyakit tidak menyebar di dalam daerah tersebut.

Biosafety adalah
aplikasi tindakan pencegahan keamanan yang bertujuan mengurangi risiko petugas
laboratorium terpapar pada mikroba infeksius dan membatasi kontaminasi di lingkungan
kerja laboratorium khususnya dan umumnya ke masyarakat luas.
Beda dengan biosecurity, istilah biosafety merupakan usaha yang dilakukan
untuk melindungi manusia dan lingkungan dari unsur-unsur yang berasal
dari bahan biologis.

Biosafety bertujuan untuk mengurangi atau menghilangkan terpaparnya

(exposure) dari suatu individu atau lingkungan terhadap agen biologik
berbahaya.

Hal ini dicapai dengan menerapkan berbagai macam tingkat kontrol

laboratorium dan ruangan (containment) melalui desain laboratorium dan
pembatasan akses, peningkatan kemampuan dan training, penggunaan
peralatan containment serta metode yang aman untuk menangani bahan
infeksius dalam lingkup laboratorium.
Biorisk Management = Assessment, Mitigation, Performance

Assessment Process of identifying the hazards and evaluating the risks associated with
biological agents and toxins, taking into account the adequacy of any existing controls,
and deciding whether or not the risks are acceptable

Mitigation Actions and control measures that are put into place to reduce or eliminate
the risks associated with biological agents and toxins

Performance The implementation of the entire biorisk management system, including

evaluating and ensuring that the system is working the way it was designed. Another
aspect of performance is the process of continually improving the system.
Konsep Biosecurity

konsep pengamanan/security pada suatu wilayah agar agen biologi

(pathogen) tidak masuk ke suatu wilayah tertentu
Penerapan Biosecurity

• Agen biologi yang tidak kasat mata.

• meminimalkan risiko yang mungkin timbul.

• membagi kawasan peternakan menjadi 3 zona.

menjadi 3 zona sebagai berikut:

• Zona Merah, untuk area dengan risiko paling tinggi. Bisa juga disebut
area kotor. Area ini adalah area di luar kawasan peternakan.
Merupakan area yang tidak bisa kita kontrol. Zona merah dan zona
lainnya dipisahkan dengan pagar fisik.

• Zona Kuning, ini merupakan area peralihan dari area merah ke area
selanjutnya yaitu area hijau. Kegiatan adminsitrasi, perkantoran dan
kegiatan yang tidak berhubungan langsung dengan ternak dilakukan
pada area ini. Pada area ini sudah bisa diterapkan SOP seperti wajib
disemprot disinfektan, mengganti alas kaki dan lain-lain

• Area Hijau, atau area yang paling bersih. Ini merupakan area yang kita
jaga agar tidak dimasuki agen penyakit. Pada area inilah ternak kita
berada.
https://disnakkeswan.ntbprov.go.id/penerapan-biosekuriti-tiga-zona/
Penerapan BSL pada intinya adalah meminimalkan risiko.

Ketiga aspek yaitu

• Tata laksana,
• peralatan dan
• fasilitas ini juga mencakup skill dari petugas lab.
Penentuan BSL (WHO) ini didukung oleh tiga aspek yaitu:

• Tata laksana pekerjaan (Standard operating procedure)

• Peralatan (Masker, alat pelindung diri (APD)
• Fasilitas (Tekanan negatif, suplai udara (AHU), double door, penanganan limbah
dll.)
Jenis Biosafety Level (BSL) Laboratorium

• BSL-1 merupakan laboratorium untuk menguji agen penyebab penyakit yang kurang
membahayakan kesehatan manusia dan mampu meminimalisir segala potensi
bahaya terhadap personel laboratorium serta lingkungannya.

• BSL-2 merupakan laboratorium untuk menguji agen penyakit yang cukup berpotensi
membahayakan petugas laboratorium dan lingkungannya.

• BSL-3 yaitu laboratorium untuk menguji agen penyakit menular yang berpotensi
serius membahayakan dan atau dapat menyebabkan kematian petugas laboratorium
akibat terpapar agen penyakit menular berbahaya melalui hirupan udara (inhalasi).

• BSL-4 yaitu laboratorium untuk menguji dengan agen penyakit menular berbahaya
dan penyakit exotic yang mempunyai risiko setiap individu tertular melalui hirupan
udara dalam laboratorium yang telah tercemari agen penyakit penyakit berbahaya
dan dapat mengancam keselamatan hidup.
 Berdasarkan tiga aspek di atas penggolongan BSL dapat dibagi menjadi 4 tingkatan yaitu:

Tingka
Tata Laksana
tan
Diperbolehkan menangani
BSL 1
mikroba di meja terbuka
Akses masuk ke Lab harus
BSL 2 dibatasi ketika ada pekerjaan
dengan mikroba
Petugas lab selalu diawasi
kesehatannya dan menerima
imunisasi terhadap penyakit
BSL 3 terkait mikroba yang dikerjakan, pekerjaan wajib dilakukan di
akses ke lab terbatas (yang tidak BSC yang sesuai
berkepentingan dilarang masuk)
Contoh
Peralatan Fasilitas
Mikroba
Disediakan tempat cuci tangan
Jas Lab, sarung tangan, (sink), lab harus memiliki pintu E. coli non
pelindung mata sendiri yang terpisah dari patogen
pintu kantor
Alat pelindung diri (jika
dibutuhkan) sarung tangan dan
Pintu harus bisa menutup
pelindung mata, Biosafety Staphylococcus
otomatis, tersedia sink dan
Cabinet (BSC), tersedia aureus
pencuci mata
autoclave untuk sterilisasi
limbah
Sink dan pencuci mata
otomatis (tidak menggunakan
tangan) di dekat pintu keluar,
Udara tidak boleh di
Wajib menggunakan APD,
resirkulasi (harus memiliki Mycobacterium
fasilitas AHU (Air Handling tuberculosis
Unit), Akses masuk dan keluar
harus menggunakan double
door.

Mengganti baju sebelum masuk,

mandi sebelum keluar lab,
dekontaminasi semua peralatan
BSL 4
dan bahan yang digunakan
sebelum
Pekerjaan dilakukan di dalam
BSC level 3 atau menggunakan
pakaian full body yang disuplai
udara bersih terus menerus,
Harus berada di Gedung
terpisah, harus memiliki AHU
Virus Ebola
terpisah dan memiliki sistem
dekontaminasi sendiri
Pengertian Biological Safety Cabinet

• Robert Koch membuat “bio-containment” cabinet

• banyak perusahaan melakukan pengembangan dalam pembuatan biological safety cabinet.

Biological safety cabinet (BSC) adalah

Suatu area kerja laboratorium dengan ventilasi udara yang telah direkayasa untuk mengamankan
pekerja yang bekerja dengan sampel material, lingkungan dan sampel material dari kemungkinan
bahaya terkontaminasi atau menimbulkan penyebaran bakteri atau virus yang bersifat patogen.
CaraKerja

Prinsip kerja BSC (Biological Safety Cabinet) yaitu menciptakan aliran masuk udara untuk melindungi operator
yang sedang menangani sampel biologis yang berisiko dengan membuang udara keluar melalui HEPA (High
Efficiency Particular Air) filter.

Tujuan dari penggunaan BSC terutama dalam laboratorium mikrobiologi yaitu untuk melindungi operator dari
mikroorganisme. Kebanyakan BSC juga menawarkan produk yang dapat menjaga sampel dari kontaminan
ruangan.

Pada umumnya terdapat dua jenis BSC berdasarkan kecepatan aliran udaranya:
1. EN12469 (EU) berkecepatan di atas 0.40 m/s.
2. NSF/ANSI 49 (USA) berkecepatan di atas 0.50 m/s.
Biosafety Cabinet Kelas I
BSC kelas I ini menyediakan perlindungan pada pekerja namun tidak pada sampel yang terdapat didalam
chamber BSC. Udara akan mengalir dari arah pekerja dan bias menyebabkan kontaminasi pada sampel.
Kecepatan minimum biosafety jenis ini 0,38 m/s. Jendela depan dibiarkan terbuka, sehingga udara masuk,
lalu dihisap dan disaring dengan HEPA filter.

Biosafety Cabinet Kelas II

BSC kelas II memiliki fungsi dapat melindungi sampel dan lingkungan. Sesuai standar dari NSF, biosafety
kelas II ini dibagi menjadi 4 tipe yaitu: tipe A1, tipe A2, tipe B1 dan tipe B2. Cara kerja dari BSC kelas II ini
yaitu menggunakan kipas hisap yang dipasang di atas lemari untuk menarik udara dari dan chamber, lalu
disaring dengan melalui HEPA filter sebelum diteruskan kembali untuk sirkulasi maupun dikeluarkan.
System menarik udara ini membuat pekerja aman karena arah udara akan mengarahkan ke dalam sistem
saringan.

Biosafety Cabinet Kelas III

BSC kelas II digunakan untuk laboratorium yang sampelnya terdiri atas bahan biologis patogen berbahaya.
Sirkulasi udara di dalam chamber tertutup rapat, dan semua material yang masuk dan keluar harus melalui
pass box. Sarung tangan disertakan di depam sehingga personil bias bekerja tanpa kontak langsung
dengan sampel
 Safe Laboratory

• Safe handling of specimens in the laboratory

• Improper collection, transport and handling of specimens in the laboratory carry a risk of infection to
the personnel involved.

• Specimen containers

• Transport of specimens within the facility

• To avoid accidental leakage or spillage, secondary containers, such as boxes, should be used, fitted
with racks so that the specimen containers remain upright. The secondary containers may be of
metal or plastic, should be autoclavable or resistant to the action of chemical disinfectants, and the
seal should preferably have a gasket. They should be regularly decontaminated

• Receipt of specimens Laboratories that receive large numbers of specimens should designate a
particular room or area for this purpose.

• Opening packages Personnel who receive and unpack specimens should be aware of the potential
health hazards involved, and should be trained to adopt standard precautions (2), particularly when
dealing with broken or leaking containers. Primary specimen containers should be opened in a
biological safety cabinet. Disinfectants should be available
Health-care waste: definition and classification

• Health-care waste includes all

the waste generated by health-
care estab- lishments, research
facilities, and laboratories. In
addition, it includes the waste
originating from “minor” or
“scattered” sources—such as
that produced in the course of
health care undertaken in the
home (dialysis, insulin
injections, etc.).
Infectious waste
Infectious waste is material suspected to contain pathogens (bacteria, viruses, parasites or fungi) in
sufficient concentration or quantity to cause disease in susceptible hosts.

• waste contaminated with blood or other body fluids

• cultures and stocks of infectious agents from laboratory work
• waste from infected patients in isolation wards.
• Waste contaminated with blood or other body fluids include free-flowing blood, blood components
and other body fluids; dressings, bandages, swabs, gloves, masks, gowns, drapes and other
material contaminated with blood or other body fluids; and waste that has been in contact with the
blood of patients undergoing haemodialysis
• Laboratory cultures and stocks are highly infectious waste.
• Waste from autopsies, animal bodies, and other waste items that have been inoculated, infected,
or in contact with highly infectious agents (based on the World Health Organization’s [WHO]
Laboratory biosafety manual (WHO, 2004) or other international or national risk-based
classification of pathogens) are highly infectious waste.
• Discarded instruments or materials that have been in contact with persons or animals infected with
highly infectious agents are also to be considered infectious waste.
Chemical waste

Chemical waste consists of discarded solid, liquid and gaseous chemicals; for
example, from diagnostic and experimental work and from cleaning and disinfecting
procedures. Chemical waste from health care is considered to be hazardous if it has
at least one of the following properties.

More details on the nature of these risks are presented :

•toxic (harmful)
•corrosive (e.g. acids of pH <2 and bases of pH >12)
•flammable
•reactive (explosive, water reactive, shock sensitive)
•oxidizing.
Harmful cytostatic drugs can be categorized as follows:

1. alkylating agents: cause alkylation of DNA nucleotides, which leads to cross-linking and miscoding
of the genetic stock;
2. antimetabolites: inhibit the biosynthesis of nucleic acids in the cell;
3. mitotic inhibitors: prevent cell replication.

Cytotoxic wastes are generated from several sources and can include the following:

1. contaminated materials from drug preparation and administration, such as syringes, needles,
gauges, vials, packaging;
2. outdated drugs, excess (leftover) solutions, drugs returned from the wards;
3. urine, faeces, and vomit from patients, which may contain potentially hazardous amounts of the
administered cytostatic drugs or of their metabolites and which should be considered genotoxic for
at least 48 hours and sometimes up to 1 week after drug administration.
Most common gases used in health care
Anaesthetic gases:
nitrous oxide, volatile halogenated hydrocarbons (such as halothane, isoflurane, and enflurane), which
have largely replaced ether and chloroform.
Applications—in hospital operating theatres, during childbirth in maternity hospi- tals, in ambulances,
in general hospital wards during painful procedures, in den- tistry, for sedation, etc.

Ethylene oxide
Applications—for sterilization of surgical equipment and medical devices, in central supply areas, and,
at times, in operating rooms.

Oxygen
Stored in bulk tank or cylinders, in gaseous or liquid form, or supplied by central piping.
Application—inhalation supply for patients.

Compressed air
Applications—in laboratory work, inhalation therapy equipment, maintenance equipment, and
environmental control systems.
International recommendations for waste management

The United Nations Conference on the Environment and Development

(UNCED) in 1992 led to the adoption of Agenda 21, which recommends a set
of measures for waste management. The recommendations may be
summarized as follows:

1. Prevent and minimize waste production.

2. Reuse or recycle the waste to the extent possible.
3. Treat waste by safe and environmentally sound methods.
4. Dispose of the final residues by landfill in confined and carefully
5. designed sites.
6. Agenda 21 also stresses that any waste producer is responsible for the
treatment and final disposal of its own waste; where possible, each
community should dispose of its waste within its own boundaries.
The WHO policy paper, Safe health-care waste management (WHO, 2004), recommends that countries conduct
assessments before choosing health-care management methods. WHO suggests that government organizations
adopt the strategies outlined below:

Short-term strategies
1. Production of all syringe components usingthe same plastic to facilitate recycling.
2. Selection of polyvinyl chloride–free medical devices.
3. Identification and development of recycling options wherever possible (e.g. for plastic, glass).
4. Research into, and promotion of, new technology or alternative to small-scale incineration.
5. Until countries in transition and developing countries have access to health-care waste-management
options that are safer for the environment and health, incineration may be an acceptable response when
used appropriately

Medium-term strategies
1. Further efforts to reduce the number of unnecessary injections, to reduce the amount of hazardous health-
care waste that needs to be treated.
2. Research into the health effects of chronic exposure to low levels of dioxin and furan.
3. Risk assessment to compare the health risks associated with (a) incineration, and (b) exposure to health-
care waste.

Long-term strategies
1. Effective, scaled-up promotion of non-incineration technologies for the final disposal of health-care waste to
prevent the disease burden from (a) unsafe health-care waste management, and (b) exposure to dioxins and furans.
2. Support to countries in developing a national guidance manual for sound management of health-care waste.
3. Support to countries in developing and implementing a national plan, policies and legislation on health-care waste.
4. Promotion of the principles of environmentally sound management of health-care waste as set out in the Basel
Convention.
5. Support to allocate human and financial resources to safely manage health-care waste in countries.
WHO also recommends the Core principles for achieving safe and sustainable management of health-care waste
(WHO, 2007).

• Governments should
• allocate a budget to cover the costs of establishment and maintenance of sound health-care waste management
systems;
• request donors, partners and other sources of external financing to include an adequate contribution towards
the management of waste associated with their interventions;
• implement and monitor sound health-care waste management systems, support capacity building, and ensure
worker and community health.

• Donors and partners should

• include a provision in their health programme assistance to cover the costs of sound health-care waste-
management systems.

• NGOs should
• include the promotion of sound health-care waste management in their advocacy;
• undertake programmes and activities that contribute to sound health-care waste management.

• The private sector should

• take responsibility for the sound management of health-care waste associated with the products and services it
provides, including the design of products and packaging.

• All concerned institutions and organizations should

• promote sound health-care waste management;
• develop innovative solutions to reduce the volume and toxicity of the waste they produce and that is
associated with their products;
• ensure that global health strategies and programmes take into account health-care waste management.
Infectious waste storage

The storage place must be identified as an infectious waste area by using the biohazard sign. Floors and walls should
be sealed or tiled to allow easy disinfection. If present, the storage room should be connected to a special sewage
system for infectious hospital wastewater. The compacting of untreated infectious waste or waste with a high content
of blood or other body fluids destined for offsite disposal (for which there is a risk of spilling) is not permitted. Sharps
can be stored without problems, but other infectious waste should be kept cool or refrigerated at a temperature
preferably no higher than 3 °C to 8 °C if stored for more than a week. Unless a refrigerated storage room is available,
storage times for infectious waste (e.g. the time gap between generation and treatment) should not exceed the
following periods:

• temperate climate
1. 72 hours in winter
2. 48 hours in summer

• warm climate
1. 48 hours during the cool season
2. 24 hours during the hot season.
The common types of treatment technologies are:
• autoclaves
• integrated or hybrid steam-based treatment systems
• microwave treatment technologies
• dry-heat treatment technologies
• chemical treatment technologies
• incinerators.