Safety Management Standard
Research facilities for mass culture 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 | Experiment zone for mass culture: 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 | Mandatory | Mandatory | |
| Separation of door to controlled zone from other zones, using air-lock, equipment storage area, dressing room, or double-door | - | - | Mandatory | Mandatory | |
| Installation of storage place to keep personal clothing and laboratory suit before entering laboratory | Recommended | Recommended | Mandatory | Mandatory | |
| Separate installation of exclusive laboratory suit storage area and personal clothing storage area, through which access to laboratory is made | - | - | Mandatory | Mandatory | |
| Installation of door or zone for transport of apparatus | - | Recommended | Recommended | Mandatory | |
| Installation of door for transport of apparatus (manual control allowed) | - | Recommended | Mandatory | Mandatory | |
| Experiment Zone | Inside sealed zone: use of material that enables chemical sterilization and fumigation | - | - | - | Mandatory |
| Seam in sealed zone: use of shock-enduring material and coating for cleanliness | - | Recommended | Recommended | Mandatory | |
| Seam in sealed zone: use of non-hardening sealant for complete sealing of facility | - | - | Mandatory | 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) | - | Recommended | Mandatory | Mandatory | |
| Installation of air supply system connected to exhaust system | - | - | Mandatory | Mandatory | |
| Installation of HEPA filter in air supply duct | - | - | Recommended | Mandatory | |
| Installation of HEPA filter in exhaust duct (two-layer HEPA filter for Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Installation of reserve exhaust filter box | - | - | Recommended | 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 (air leak rate of within 10%) (enduring pressure of 2,500Pa or over (air leak rate of within 1%) for airing HEPA filter box and duct in Level 4 research facility) | - | - | Mandatory | Mandatory | |
| Experimenter Safety Protection | Installation of hand sterilizer and eye washer in laboratory | Recommended | Recommended | Mandatory | Mandatory |
| Installation of emergency shower facility in close location to dressing zone for taking off contaminated laboratory suit | - | Recommended | Recommended | 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 | |
| Design for LMO leak prevention. Installation of culture equipment capable of sterilization control in closed state. Inspection of sealing status right after installation of culture device and on a regular basis | - | Recommended | Mandatory | Mandatory | |
| Installation of bacteriostatic filter or bacteriostatic device having at least equivalent effect in exhaust pipe of culture device. Performance inspection right after installation and on a regular basis | - | Mandatory | Mandatory | Mandatory | |
| Inspection of sealing status and performance of any equipment and device in case that any part of it related to sealing is modified or replaced | - | Mandatory | Mandatory | Mandatory | |
| Installation of sealing status detection equipment for culture equipment and any device directly connected to it | - | - | Recommended | 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 | Recommended | Mandatory | Mandatory | Mandatory | |
| Exhaust through HEPA filter | - | 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 DOP nozzle of exhaust HEPA filter box | - | - | Mandatory | Mandatory | |
| Installation of observable inner pressure gauge and warning equipment | - | - | Mandatory | Mandatory | |
| Installation of reserve power supply facility for air-conditioning and mandatory facility in case of blackout | - | - | 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 | Wash hands upon finishing experiment or exiting mass culture experiment zone. | 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 | |
| Check sealing status of culture container at least once a day if culture experiment is underway. | - | - | Mandatory | Mandatory | |
| Pay attention to any contamination during inoculation into culture equipment, sampling and transport. (Sterilize instantly upon contamination.) | - | - | Mandatory | Mandatory | |
| Sterilize biosafety cabinet, bacteriostatic filter of other equipment, etc. right before replacement and during regular inspection. | - | - | Mandatory | Mandatory | |
| Establish management method for insects or rodents. | Mandatory | Mandatory | Mandatory | Mandatory | |
| Wear laboratory suit for mass culture experiment in laboratory. 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 |
| Attach marking to culture equipment, etc. running for mass culture experiment according to the level | - | 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 | |
| Keep inspection record and operation record as well as serial ID number for each piece of facility and device | - | - | Recommended | Mandatory | |
| Establish and apply biosafety management regulation. (Establish facility operation regulation separately for Level 3∙4 research facility.) | Recommended | Mandatory | 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 | Recommended | Mandatory | |
| Experimenter Safety Protection | Contaminated waste before treatment: keep it in separate safe location or container. | Recommended | Mandatory | Mandatory | Mandatory |
| Deactivate any waste material and waste liquid generated from culture equipment, culture medium, contaminated equipment and device, and organisms related to mass culture experiment before disposal, after finishing mass culture experiment. | Recommended | Mandatory | Mandatory | Mandatory | |
| Establish regulation on laboratory waste treatment. | Mandatory | Mandatory | Mandatory | Mandatory | |
Note : As for safety management levels, research facilities for mass culture are classified into GLSP(Good Large Scale Practice), Level 1, Level 2 and Level 3, each corresponding to Level 1, Level 2, Level 3 and Level 4 prescribed in Attached Table 1 of the Enforcement Decree.