Safety Management Standard
General research facilities should comply with the following standard on installation and operation.
Installation Standard
| Compliance | Safety Management Level | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
| Location of and Access to Laboratory | Laboratory (experiment zone): separation (division) from general zone | Recommended | Recommended | Mandatory | Mandatory |
| Installation of locking equipment in the main gate (card, fingerprint recognition system, security system, etc.) | Recommended | Recommended | Mandatory | Mandatory | |
| Installation of storage place to keep personal clothing and laboratory suit before access to laboratory | Recommended | Recommended | Mandatory | Mandatory | |
| Access to laboratory: installation of entrance, equipment storage area, etc. to be passed before access to laboratory | - | Recommended | Mandatory | Mandatory | |
| Installation of door for transport of apparatus | - | Recommended | Mandatory | Mandatory | |
| Installation of equipment that prevents interactive opening of doors in the zone (manual control allowed) | - | - | Mandatory | Mandatory | |
| Door: installation of door that enables air inflation or compression seal | - | - | Recommended | Mandatory | |
| Installation close to air-conditioning equipment room | - | - | Recommended | Mandatory | |
| Sealed facility: a separate, exclusive building for experiment, that is enclosed by concrete walls | - | - | Recommended | Mandatory | |
| Establishment of space for maintenance of research facility | - | - | Mandatory | Mandatory | |
| Experiment Zone | Inside sealed zone: use of material that enables chemical sterilization and fumigation | - | - | Mandatory | Mandatory |
| Use of material in inner walls of sealed zone, that ensures sealing, such as concrete | - | - | Recommended | Mandatory | |
| Seam in sealed zone: use of non-hardening sealant for complete sealing of facility | - | - | Mandatory | Mandatory | |
| Fitting of HEPA (high-efficiency particulate arrestance) filter when installing vacuum pump line supplied from the outside | - | - | Mandatory | Mandatory | |
| Inner wall: installation by ensuring no distortion or damage caused by pressure that is 1.25 times the preset pressure in design | - | - | - | Mandatory | |
| Air-conditioning | Air inside sealed zone: maintenance of negative pressure and prevention of recirculation | - | - | Mandatory | Mandatory |
| Pressure difference between outside and maximum negative pressure zone: maintenance of -24.5Pa or over (±30% variation allowed) | - | - | Mandatory | Mandatory | |
| Facility ventilation: at least 10 cycles per hour (at least 20 cycles per hour for Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Installation of air supply system connected to exhaust system | - | - | Mandatory | Mandatory | |
| Installation of HEPA filter in air supply duct (mandatory in animal zone) | - | - | Recommended | Mandatory | |
| Installation of HEPA filter in exhaust duct (installation of two-layer HEPA filter for Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Installation of reserve exhaust filter box | - | - | Recommended | Mandatory | |
| Installation of back draft damper (BDD) in airing duct | - | - | Mandatory | Mandatory | |
| Installation of airtight damper in front end of exhaust HEPA filter (installation of bubble-tight damper or at least equivalent damper for Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Front end duct of exhaust HEPA filter and exhaust HEPA filter box: enduring pressure of 1,000Pa or over for 30mins (air leak rate of within 10%) for Level 3 research facility, and enduring pressure of 2,500Pa or over for 30mins (air leak rate of within 1%) for Level 4 research facility | - | - | Mandatory | Mandatory | |
| Experimenter Safety Protection | Installation of hand sterilizer and eye washer in experiment zone or laboratory (eye washer is excluded for suite-type Level 4 research facility) | - | Recommended | Mandatory | Mandatory |
| Installation of emergency shower facility in sealed zone (with the exception of suite-type Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Installation of chemical shower equipment for undressing of contaminated laboratory suit | - | - | - | Mandatory | |
| Installation of positive pressure suit and compressed air feeder (with the exception of cabinet-type Level 4 research facility) | - | - | - | Mandatory | |
| Experiment Apparatus | Installation of autoclave (installation of double door autoclave for Level 3∙4 research facility) | Mandatory | Mandatory | Mandatory | Mandatory |
| Installation of biosafety cabinet | - | Recommended | Mandatory | Mandatory | |
| Use of centrifuge capable of preventing leak of aerosol | - | Recommended | Mandatory | Mandatory | |
| Installation of breeding equipment that includes HEPA filter-fitted air supply and exhaust systems in case of animal use (separate duct connection) (two-layer HEPA filter processing for Level 4 research facility) | - | Recommended | Mandatory | Mandatory | |
| Waste Treatment | Solid waste: installation of facility that can remove biological activation, such as autoclave or chemical processing | Recommended | Mandatory | Mandatory | Mandatory |
| Waste water from experiment: installation of facility that can remove biological activation, such as autoclave or chemical processing (installation of autoclave for Level 4 research facility) | Recommended | Mandatory | Mandatory | Mandatory | |
| Exhaust through HEPA filter (two-layer HEPA filter processing for Level 4 research facility) | - | Recommended | Mandatory | Mandatory | |
| Other Facilities | Installation of communication equipment connected to the outside of facility | Recommended | Recommended | Mandatory | Mandatory |
| Installation of back draft prevention equipment for pipe | - | Recommended | Mandatory | Mandatory | |
| Installation of nozzle for HEPA filter box decontamination and test | - | - | Mandatory | Mandatory | |
| Installation of observable inner pressure gauge and warning device | - | - | Mandatory | Mandatory | |
| Installation of reserve power supply facility for air-conditioning and mandatory facility in case of blackout | - | - | Mandatory | Mandatory | |
| Installation of carbon filter in exhaust system in zones that can have much smell, such as animal experiment zone | - | Recommended | Mandatory | Mandatory | |
Operation Standard
| Compliance | Safety Management Level | ||||
|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | ||
| Access to Experiment Zone |
Keep door to laboratory always closed. Allow only approved persons to enter. |
Recommended | Mandatory | Mandatory | Mandatory |
|
Place and record access card. |
- | Recommended | Mandatory | Mandatory | |
|
Place and use protective equipment such as exclusive laboratory suit. |
Recommended | Recommended | Mandatory | Mandatory | |
|
Attach biosafety marking (LMO name, safety management level, name and contact of facility manager, etc.) in front of door. |
Recommended | Mandatory | Mandatory | Mandatory | |
| Activity in Experiment Zone |
Conduct experiment in designated zone only. Wash hands upon finishing experiment or exit. |
Mandatory | Mandatory | Mandatory | Mandatory |
|
Wear laboratory suit in experiment zone. Take off laboratory suit before moving to general zone. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Use mechanical pipette during experiment. |
Mandatory | Mandatory | Mandatory | Mandatory | |
|
Minimize occurrence of aerosol during experiment. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Prohibit food consumption, food preservation, smoking and makeup application in experiment zone. |
Mandatory | Mandatory | Mandatory | Mandatory | |
|
Prohibit carry-in of articles irrelevant to experiment, such as plants, animals and clothes. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Carry infectious material in strong sealed container. |
- | Recommended | Mandatory | Mandatory | |
|
Establish management method for insects or rodents. |
Mandatory | Mandatory | Mandatory | Mandatory | |
|
Sterilize work bench after finishing experiment. (Sterilize it instantly upon contamination during experiment.) |
- | Mandatory | Mandatory | Mandatory | |
|
Take off laboratory suit upon exit and take shower to remove contamination. |
- | - | Recommended | Mandatory | |
| Biosafety |
LMO storage (refrigerator, freezer, etc.): attach "Biohazard" marking, etc. |
Mandatory | Mandatory | Mandatory | Mandatory |
|
Organize biosafety committee and appoint biosafety management director. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Designate biosafety manager. |
Recommended | Recommended | Mandatory | Mandatory | |
|
Conduct and attend education on biosafety. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Manage and keep record related to installation and operation of research facility. |
Mandatory | Mandatory | Mandatory | Mandatory | |
|
Record and keep LMO storage and management document. |
Mandatory | Mandatory | Mandatory | Mandatory | |
|
Write, report and keep record about infection accidents that occur during experiment. |
- | Recommended | Mandatory | Mandatory | |
|
Establish and apply biosafety management regulation. (Establish facility operation regulation separately for Level 3∙4 research facility.) |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Opening of objects containing infectious material: open such objects in biosafety cabinet or other physically sealed apparatus. |
- | Recommended | Mandatory | Mandatory | |
|
Collect and keep normal serum of persons engaging in test and research. (Conduct serum collection and health checkup on a regular basis, if needed.) |
- | Recommended | Mandatory | Mandatory | |
|
Conduct inoculation of vaccine, if any, against pathogen being treated. |
- | Recommended | Mandatory | Mandatory | |
| Waste Treatment |
Contaminated waste before treatment: keep it in separate safe location or container. |
Recommended | Mandatory | Mandatory | Mandatory |
|
Treat any kind of waste (including litter) by removing biological activation. |
Recommended | Mandatory | Mandatory | Mandatory | |
|
Establish regulation on laboratory waste treatment. |
Mandatory | Mandatory | Mandatory | Mandatory | |