Medical device company microbiology laboratory of the positive control room, sterile laboratory, microbial limit room of each room are probably what work?

Positive control laboratory, a major technical indicators of the determination

BLS-2 laboratory is mainly used for primary health services, diagnosis and research, the object of the hazard class II (moderate individual hazard, limited group hazard), specifically defined as "can cause disease in humans or animals, but in general for the health of the workers, the group, livestock or the environment does not cause serious harm to the source of the disease. A pathogen that can cause disease in humans or animals, but generally does not cause serious harm to healthy workers, populations, livestock, or the environment. Laboratory infections do not cause serious disease, effective treatment and prevention measures are available, and the risk of transmission is limited". Accordingly, to be promulgated by the national standard "biosafety laboratory building technical specifications for BLS-2 laboratory specifies the following technical indicators (static):

1, cleanliness: no requirement

2, the minimum number of air changes: can be ventilated by opening the window

3, and the outdoor direction of the pressure difference between the neighboring rooms: no requirement

4, the temperature of ℃: 18 ~ 27

5, the relative temperature: 18 ~ 27

5, the relative pressure: 18 ~ 27

5, the relative temperature: 18 ~ 27

5, the relative temperature: 18 ~ 27

5, relative humidity %: 30 ~ 70

6, noise dB (A): ≤ 60

7, the minimum illuminance lx: 300

* Appeal index is the establishment of the minimum requirements of the BLS-2 laboratories, the builder may be appropriate to improve the corresponding indicators according to the actual needs of, such as cleanliness, differential pressure and so on.

II. Architecture, structure and decoration requirements

Now most of the BLS-2 laboratory in the original building for the reconstruction, unlike the new BLS-2 laboratory (the national standard, the requirements of the new BLS-2 laboratory is appropriate to leave the public **** place a distance), in the room with the neighboring other rooms, there is a relative isolation problem. So in the original building in the reconstruction of BLS-2 laboratory, should focus on the following issues.

1, in the **** with the building in the BLS-2 laboratory, should be set up to automatically close the door with a lock, if necessary, can set up a buffer area, such as buffer room.

2, if there is no mechanical ventilation system, there should be windows for natural ventilation, and there should be insect screens. (In general, there should be mechanical ventilation system, otherwise, the temperature and humidity indicators are difficult to ensure).

3, there should be anti-insects, rodents and other animals to enter and escape measures.

Three. Air conditioning, ventilation and purification

In order to meet the temperature and humidity requirements of the BLS-2 laboratory, it is appropriate to equip mechanical air conditioning and ventilation system, there are special requirements can be added to the design requirements, such as the addition of purification requirements and purification requirements for the return of the (exhaust) air system design. In this regard, should focus on the following issues:

1, can be used with circulating air conditioning system. If it involves chemical solvents, infectious materials operations and animal experiments, the full exhaust air system should be used.

2, biological safety cabinets and exhaust air system connection

Class I exhaust ratio of 100%, airtight connection.

Class II A exhaust proportion of 30%, can be discharged to the room or set up a local exhaust hood.

Type B1 exhaust ratio of 70%, airtight connection.

Type B2 exhaust ratio of 100%, airtight connection.

3, a variety of equipment in the laboratory should be conducive to the location of the air flow from the "clean" space to the "contaminated" space flow, minimize indoor reflux and leakage (biosafety cabinets should be placed in the indoor downstream of the airflow, that is, the furthest away from the air outlet). (Biosafety cabinets should generally be placed downstream of the airflow in the room, i.e. furthest away from the air supply outlet).

*Biological safety cabinet exhaust can not replace the indoor exhaust.

Four. Drainage

Bacteria-containing sewage should be sterilized by high temperature and pressure or chemical disinfection and then discharged to the municipal sewage public system.

V. Electrical setup

1, there should be a special power distribution box.

2, the power supply should be set up leakage detection alarm device.

3, there should be a reliable power system, its grounding resistance should not be greater than 1Ω.

4, laboratory entrance should be laboratory work status of text-based light signal display.

5, there should be an emergency lighted evacuation signs.

VI. Fire

Building fire rating of not less than two.

VII. Should be equipped with process equipment

1, biological safety cabinets

(1) generate microbial aerosols or the emergence of spattering operations, you can use class I biological safety cabinets.

(2) handling of sensible materials, should use Class II biological safety cabinet;

(3) handling of chemical carcinogens, radioactive substances and volatile solvents, should use Class II-B biological safety cabinet.

2, high temperature and high pressure sterilization and disinfection cabinet.

3, eyewash, if necessary, should be set up emergency spray device.

*Ultra-clean bench does not belong to the biological safety cabinet, can not be used for biological safety operations.

BLS-2 laboratory is used for preliminary biosafety experiments, the national standard specifies the corresponding requirements. The establishment of BLS-2 laboratory should be based on the national standard, under the premise of ensuring safety to determine the construction objectives, the establishment of the laboratory should be safe and economical laboratory.

P2 level laboratory general specifications

I. Isolated equipment

1) need to set up biosafety operating devices (level 1 or level 2), and to do regular checks.

2)When instruments such as grinders, freeze dryers, ultrasonic cell breakers, and centrifuges that are prone to generating aerosols are used for the purpose of processing recombinant bodies, these instruments need to be placed in a safe operating device. However, if the machine is already equipped with a device to prevent the leakage of aerosols, this is not required.

3)The laboratory must have an autoclave for the sterilization of contaminants and waste.

2. Experiment implementation

1)When conducting experiments, the laboratory doors and windows must be closed.

2)After each day's experiment, we must sterilize the laboratory table and the safety operation device. If contamination occurs during the experiment, it must be sterilized immediately.

3)Waste of biological materials related to experiments should be sterilized before disposal. Contaminated equipment should be sterilized by autoclave before cleaning and use or disposal.

4)Do not use the mouth for pipetting.

5)Eating, drinking, smoking and keeping food in the laboratory are prohibited.

6)Gloves should be worn when handling recombinant to prevent contamination, and hands should be washed after handling and before leaving the laboratory.

7)Aerosol generation should be avoided in all operations (e.g., when inserting a hot platinum ring for inoculation and an inoculation needle into the culture medium, contamination may occur if a large amount of aerosol is generated). Avoid ejecting the liquid from the pipette or syringe with force.

8)When removing contaminated materials from the laboratory, they must be placed in a sturdy, leak-tight container and sealed within the laboratory before being transported.

9)Prevent and control non-laboratory organisms such as insects and rodents in the laboratory.

10)Avoid the use of needles if other methods are available.

11)In the laboratory, wear lab coats and remove them before leaving.

12)People who are unaware of the nature of the experiment are prohibited from entering the laboratory.

13)When experiments are in progress, the entrance to the lab is labeled "P2 Lab" and the sign "P2 Experiment in Progress" is hung up. The refrigerator and freezer where the recombinant is stored should also be labeled as such.

14)The laboratory should be cleaned frequently and no objects unrelated to the experiments should be placed there.

15)The HEPA filter in the safety device should be sealed and fumigated with 10 grams of formaldehyde per cubic meter for 1 hour to remove contamination before replacing it, during regular inspections, and when the content of the experiment is changed.

16)If P1 level experiments are to be conducted in this lab at the same time, the experimental area should be clearly divided and carefully operated.

17)Other matters as specified by the program coordinator should be observed.

Animal Facilities - Level 2 Biosafety

Level 2 Biosafety Animal Facilities are used for animals inoculated exclusively with Hazard Level 2 microorganisms, and require the following safety precautions:

1. All requirements of Level 1 Biosafety Animal Facilities must be met. all requirements.

2. Biohazard warning signs (see Figure 1) are posted on doors and other appropriate places.

3. The facility must be designed for easy cleaning and management.

4. Doors must open inward and can close automatically.

5. There must be proper temperature, ventilation and lighting.

6. If mechanical ventilation is used, the direction of airflow must be inward. Exhausted air is to be discharged to the outside and must not be circulated within the building.

7. Authorized personnel may enter only.

8. Only experimental animals are admitted.

9. Control programs for arthropods and rodents shall be established.

10. Windows, if any, must be secure and shatter-resistant. If the windows can be opened, arthropod-resistant screens must be installed.

11. After use, work surfaces should be decontaminated with an effective disinfectant (see Chapter 14).

12. Work that may generate aerosols must be done using a biological safety cabinet (Class I or Class II) or an isolation box with a dedicated air supply and HEPA-filtered exhaust.

13. Autoclaves are available at or near the site of animal facilities.

14, clean up animal bedding must minimize the generation of aerosols and dust.

15, all waste and bedding must be decontaminated before disposal.

16. The use of sharp instruments should be limited as much as possible. Sharps should always be collected in puncture-proof containers with lids and disposed of as infectious material.

17, for autoclaving, incineration of the items should be in closed containers for safe transportation.

18, animal cages must be decontaminated after use.

19, animal carcasses must be incinerated.

20. Protective clothing and other equipment must be worn while in the facility and removed when leaving.

21. Hand washing facilities must be available. Personnel must wash their hands before leaving the animal facility.

22. If an injury occurs, regardless of the severity, it must be treated appropriately and reported and documented.

23. Eating, drinking, smoking and applying makeup are prohibited in the facility.

24 All personnel must receive appropriate training.

Aseptic Operation Laboratory

Aseptic laboratory is a small room used for aseptic operation within the bacteriological laboratory, which has more stringent requirements for interior decoration and sterilization conditions.

1. The aseptic room should be completely closed, personnel access should have two doors, which should be separated by a buffer zone.

2. It should be sterilized by ultraviolet light for 30min before use, and fumigated with lactic acid or formaldehyde regularly for thorough disinfection.

3. In the aseptic room is generally limited to the distribution of sterile culture media and inoculation of highly infectious bacteria, not the isolation of bacterial specimens and other operations.

4. The sterile room should be limited to the operator to enter, and enter the sterile room should be wearing isolation clothing and special shoes, wear a mask when operating, at any time to ensure that the interior of the sterile state.

5. Limited conditions of the laboratory, the ultra-clean bench can be used to replace the sterile laboratory for the corresponding operation. Ultra-clean bench should choose vertical airflow ventilation.

6. Aseptic room should be equipped with air conditioning equipment to ensure that the room temperature does not affect the work

Try to ensure that you can maintain the sterility of the operation process

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Microbial limitation of the room this is not very clear