Friday, October 7, 2016

Biological Safety / Biosafety Level 1 BSL 1


Biosafety Level 1 (BSL-1) is suitable for work involving agents of no known or minimal potential hazard to laboratory personnel and the environment. The laboratory may be integral to general traffic patterns in the building.

Work may be conducted on open bench tops. Special containment equipment is neither required nor generally used. Laboratory personnel shall have specific training in procedures conducted in the laboratory.

Biological Safety / Biosafety Level 2 BSL 2




Biosafety Level 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment.
 It differs in that
(1) laboratory personnel are specifically trained to handle pathogenic agents and are directed by scientists who are experienced in working with these agents,
(2) access to the laboratory is limited when work is being conducted,
(3) extreme precautions are taken with contaminated sharp items, and
(4) certain procedures that may result in the creation of infectious aerosols or splashes are conducted in biological safety cabinets or other physical containment equipment.

Biological Safety / Biosafety Level 3 BSL 3




Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is done with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents, and are supervised by competent scientists who are experienced in working with these agents.

All procedures involving the manipulation of infectious materials are conducted within biological safety cabinet. It is recognized, however, that some existing facilities may not have all the facility features recommended for Biosafety Level 3 (i.e., double-door access zone and sealed penetrations).

In this circumstance, an acceptable level of safety for the conduct of routine procedures, (e.g., diagnostic procedures involving the propagation of an agent for identification, typing, susceptibility testing, etc.), may be achieved in a Biosafety Level 2 facility, providing

 1) the exhaust air from the laboratory room is discharged to the outdoors,
2) the ventilation to the laboratory is balanced to provide directional airflow into the room,
3) access to the laboratory is restricted when work is in progress, and
4) the recommended Standard Microbiological Practices, Special Practices, and Safety Equipment for Biosafety Level 3 are rigorously followed.

Biological Safety / Biosafety Level 4 BSL 4




Biosafety Level 4 is required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted laboratory infections and life-threatening disease. Agents with a close or identical antigenic relationship to Biosafety Level 4 agents are handled at this level until sufficient data are obtained either to confirm continued work at this level, or to work with them at a lower level. Members of the laboratory staff have specific and thorough training in handling extremely hazardous infectious agents and they understand the primary and secondary containment functions of the standard and special practices, the containment equipment, and the laboratory design characteristics. They are supervised by competent scientists who are trained and experienced in working with these agents. Access to the laboratory is strictly controlled by the laboratory director.

The facility is either in a separate building or in a controlled area within a building, which is completely isolated from all other areas of the building. A specific facility operations manual is prepared or adopted.

Within work areas of the facility, all activities are confined to Class III biological safety cabinets, or Class II biological safety cabinets used with one-piece positive pressure personnel suits ventilated by a life support system. The Biosafety Level 4 laboratory has special engineering and design features to prevent microorganisms from being disseminated into the environment.


Monday, October 3, 2016

Arboviruses and Certain Other Viruses Assigned to Biosafety Level 3 BSL-3

Arboviruses and Certain Other Viruses Assigned to Biosafety Level 3 BSL-3


 Arboviruses and Certain Other Viruses Assigned to BSL-3
Aino Murray Valley enc.
Akabanec Nairobi sheep diseasea,i
Bannaa,f Ndumu
Bhanja Negishi
Central Eur. TBE b,d (Absettarov, Hanzalova, Hypr, and Kumlinge) Oropouchec
Orungo
Chikungunyac,d Peaton
Cocal Piryi
Dhori Powassan
Dobrava-Belgrade Puumala
Dugbe Rift Valley fevera,c,d,h,i
Evergladesc,d Rocioc
Flexal Sagiyama
Germistonc Sal Vieja
Getah San Perlita
Hantaanh Semliki Forest
Israel Turkey mening. Seoul
Japanese enc.h Sin Nombre
Juninc,d,h Spondweni
Kairi St. Louis enc.
Kimberley Thogoto
Koutango Turuna
Kumlinge (Cent. Eur. TBE) Venezuelan equine encephalitisc,d,h,i
Louping IIIa,c,h Vesicular stomatitus (Alagoas)h,i
Mayaro Wesselsbrona,c,i
Middelburg West Nile
Mobala Yellow feverc,d
Mopeiae Zingag
Mucamboc,d  
  1. The importation, possession, or use of this agent is restricted by USDA regulation or administrative policy.

  2. Central European Tick Borne Encephalitis virus (CETBE) is not a registered name in The International Catalogue of Arboviruses-1985. Until the registration issue has been resolved taxonomically, CETBE refers to the following group of very closely related, if not essentially identical, tick-borne flaviviruses isolated from Czechoslovakia, Finland and Russia: Absettarov, Hanzalova, Hypr, and Kumlinge. These four viruses are antigenically homogeneous and are distinguishable from Russian Spring-Summer encephalitis (RSSE) virus. While there is a vaccine available which confers immunity to the CETBE group of genetically (>98%) homogeneous viruses, the efficacy of this vaccine against RSSE virus infections has not been established. Thus, SALS has reclassified the CETBE group of viruses as Biosafety Level 3 when personnel are immunized with CETBE vaccine. RSSE remains classified as a Biosafety Level 4 virus.

  3. Subcommittee on Arbovirus Laboratory Safety (SALS) recommends that work with this agent should be conducted only in Biosafety Level 3 facilities that provide for HEPA filtration of all exhaust air prior to discharge from the laboratory.

  4. A vaccine is available and is recommended for all persons working with this agent.

  5. This virus is presently being registered in the Catalogue of Arboviruses.

  6. Scientists from the People's Republic of China have verbally reported Banna virus to be associated with severe human cases of encephalitis. Translations of the original publications from Chinese into English were not available for this revision.

  7. Zinga virus is now recognized as being identical to Rift Valley Fever virus.

  8. Export permit required from Department of Commerce.

  9. An importation or domestic transfer permit for this agent can be obtained from USDA/APHIS/VS.

Tuesday, September 27, 2016

Rules to be followed in the Cleanrooms


Within a cleanroom, many rules-of-conduct must be followed to ensure that products are not contaminated. The management must produce a set of written procedures suitable for their room. It may be useful to have these 'does and don'ts' posted in the change or production area. Commonly used procedures that may be adopted are given below. These procedures do not consider the choice of cleanroom garments, masks, gloves and similar clothing items.

Air Transfers with in the Cleanrooms To ensure that air is not transferred from an area of high contamination to one of lower contamination (e.g. the outside corridor to the production room) the following disciplines should be adhered to:

Personnel must always come in and out of the cleanroom through change areas. The change area is used not only to change clothing, but as a buffer zone between the outer dirty corridor and the inner clean production area. Personnel should not use any entrance, such as an emergency exit, which leads directly from the production area to the corridor; this will allow contamination to enter directly into the cleanroom, and their garments may also become contaminated.

Doors should not be left open. If they are, air will be transferred between the two adjoining areas because of general air turbulence as well as air transfer caused by a temperature difference between the two areas

Doors should not be opened or closed quickly, or air will be pumped from one area to the other.

Doors usually open inwards into the production room and are held shut by the higher pressure. However, to aid the movement of personnel who are carrying materials, some doors open outwards. Doors should then be fitted with door-closing devices to ensure that the doors are kept closed, and shut slowly to reduce the air transfer. Doors without handles will assist in preventing contamination of gloves.

When passing through the doors in an airlock, personnel should ensure the first door is closed before going through the Next one. Electrical interlocks between entry and exit doors achieve this, but care must be taken to ensure that there is no danger in the case of fire. Indicator lights, which show if the doors are shut, are also used. Pass-through hatches should be used in a similar way.

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Wednesday, September 21, 2016

Cleanroom Particle Generations and Average Particle Generations by Human Activity and Clothings

What is Particle Concentration?
The number of particles detected per unit volume of air 

Particle Concentration in Different Locations

Place                Number of Particles per cubic foot 
                         (greater than or equal to 0.5┬Ám)

Town                1000000
Mountain          100000
Moon                100
Industrial          10000000

Particles Generated by Clothing Activities

Activity                     Normal Street Clothing  Laboratory Clothing   Cleanroom Garments

Sitting Still                448000                             142000                        14920

Sitting and
 Moving Arms          4450000                            462000                        48600

Standing 
and Rotating             2240000                            390000                        31700

Walking Rapidly      5380000                            1285000                       15700


Particles Generated from Human Activity

Activity                                 Number of Particles released

Sitting                                   100000

Sitting awith 
Rotating Arm 
Movements                          500000

Rising Up 
and Sitting Down                 2500000

Running and 
Walking Up                          10000000


Particles Generated From Human Beings

Human skin can produce upto 1 x 106 microorganisms per cm2

Human saliva can contain upto 1 x 109 microorganisms per ml

Nasal Wash (from healthy person) can obtain 1 x 106 microorganisms per ml

The aerosol produced by sneezing (if no barrier is used) can contain 100000 microorganisms

Human excrement can contain 1x1012 microorganisms per g. This figure correspondance to approximately 50% of the dry weight of the excrement














Major and Minor Sources of Cleanroom Contamination in Cleanrooms

Major Source of Cleanroom Contamination  Sources

* Personnel
* Incoming Air
* Machineries
* Raw Material
* Packing Material
* Chemicals Used for Cleaning
* Office Equipment and Material
* Visitors
* Maintenance Personnel

General Source of Indoor Environment Cleanroom Contaminations
People
skin scales, microorganisms, tobacco, smoke, hair, textile fibres
Cleaning Activities
choice of material and chemicals
Machineries
painting, welding and grinding
Construction Material
fibrous insulation material, microorganisms in wet wood

General Source of Outdoor Environment Cleanroom Contaminations
Natural Processes
wind, fire and natural cycle of plants
Manmade Processes
fossil material waste disposal


Tuesday, September 13, 2016

Types of Cleanroom Based on Operational Conditions and Air Flow Directions

Cleanroom Types as Based on Operational Conditions



as-built Cleanroom Facility
A cleanroom facility that is complete and ready for operation, with all services connected and functional, but without equipment or operating personnel in the facility

as-rest Cleanroom Facility
A cleanroom facility that is complete, with all services functioning and with equipment installed and operable or operating as specified, but without operating personnel in the facility

Operational Cleanroom Facility 
A cleanroom facility in normal operation, with all services functioning and with equipment and personnel, if applicable, present and performing their mormal work functions in the facility

Cleanroom Types Based on Air Flow Direction

Mixed Airflow Cleanrooms 
A hybrid cleanroom containing both unidirectional and nonunidirectional types of airflow within the same enclosure

Nonunidirectional Airflow Cleanrooms

A cleanroom in which the filtered air entering the room or passing through the work zone is characterized by nonuniform velocity or turbulent flow. Such rooms exhibit nonuniform, random airflow patterns throughout the enclosure

Unidirectional Aiflow Cleanrooms / Laminar airflow Cleanrooms

A Cleanroom in which the filtered air entering the room makes a single pass through the work area in parallel flow pattern, with a minimum of turbulent flow areas. Unidirectional airflow rooms typically have HEPA or ULPA filter coverage of 80% or more of the ceiling (vertical flow) or one wall (horizontal flow)