Sterile Laboratory (Sterile Room, Sterile Chamber, Lab)

Industry Adaptability: Microbiology, Biomedicine, Biochemistry, Animal Experiments, Genetic Recombination

Suggested Grade: 100th - 100,000th (Biosecurity Laboratory: Suggested Grade: 1st - 10,000th)

Sterile Laboratory (Sterile Room, Sterile Chamber, Laboratory) Design:

The sterile laboratory is composed of six sections: preparation room, washing room, sterilization room, sterile room, constant-temperature culture room, and general laboratory. The common features of these dust-free rooms are smooth and hard floors and walls, simple arrangement of instruments and equipment, and ease of cleaning.

Sterile Laboratory (Sterile Room, Sterile Chamber, Testing Laboratory) Basic Requirements:

Preparation Room: The preparation room is used for preparing culture media and sample processing, etc. The clean room is equipped with reagent cabinets, dedicated cabinets for storage of equipment or materials, laboratory tables, electric furnaces, refrigerators, plumbing, and electrical power supplies.

Washing Room: The washing room is used for cleaning utensils. Since used utensils are contaminated by microorganisms, pathogens may also be present. Therefore, it is recommended to set up a washing room when conditions permit. The room should be equipped with a heater, a steamer, basins or buckets for cleaning utensils, and a variety of bottle brushes, degreasers, soap, and laundry detergent.

Sterilization Room: The sterilization room is primarily used for sterilizing culture media and various instruments. The cleanroom should be equipped with sterilization equipment and facilities such as high-pressure steam sterilizers and ovens.

Sterile Room: Also known as an inoculation room, a sterile room is a specialized laboratory designed for sterile operations such as system inoculation and strain purification. In microbiological work, the inoculation and transplantation of strains is a primary operation, characterized by ensuring strain purity and preventing contamination by pathogenic microorganisms. In the air of general environments, due to the presence of numerous dust particles and pathogenic microorganisms, contamination is very likely, which can greatly interfere with the inoculation process.

Sterilization and disinfection for sterile laboratories (sterile room, sterile chamber, lab)

Sterilization by Fumigation: This is a thorough sterilization measure for the sterile room. When the sterile room has been used for a long time and contamination is severe, fumigation sterilization should be conducted. Formaldehyde, lactic acid, or sulfur can be used for fumigation.

Spray: Perform before each use in the sterile room. Spraying can promote the sedimentation of particles and microorganisms in the air, prevent the floating of dust on tables and floors, and have sterilization effects. A 5% carbonic acid spray can be used.

Ultraviolet Irradiation: Perform before each use of the sterile room. Ultraviolet light has good sterilization effects. Typically, the UV light should be on for 30 to 60 minutes.

GMP Cleanroom (Clean Room, Sterile Room, Lab) Operation Procedures:

Aseptic room sterilization: Turn on the ultraviolet light for at least 30 minutes before each use, or spray 5% carbolic acid on the interior and exterior of the room 30 minutes prior to use.

Sterilization: Wash hands with soap, then move the required equipment to the outer room; change into sterile work clothes, hat, and shoes in the outer room, wear a mask, and then soak hands in 2% coal tar soap solution for 2 minutes.

Design Basis for Biosecurity Laboratory:

In compliance with the "Technical Code for Construction of Biological Safety Laboratories" (GB-50346-2004), "General Requirements for Laboratory Biological Safety" (GB19489-2004), "General Guidelines for Safety in Microbiological and Biomedical Laboratories" (WS233-2002), "Design Code for Clean Factory Buildings" (GB50073-2001), and "Design Code for Heating, Ventilation, and Air Conditioning" (GBJ19-87), the biological safety laboratory is specifically designed for pathogenic agents that pose moderate hazards or potential dangers to humans, animals, or the environment. These agents do not cause severe harm to healthy adults, animals, or the environment, and there are effective prevention and control measures in place.

Description:

1. Cleanroom changing rooms and operation rooms supply air velocity ≥0.3 m/s, air shower room velocity ≥15 m/s, cleanroom operation room and environmental static pressure difference ≥5 Pa, system noise ≤60 dB.

2. The P2 grade sterile room is a 10,000-class and partial 100-class, compliant with the currently universally accepted US Federal Standard 209E.

3. The Grade 2 sterile room is equipped with a high, medium, and pre-efficiency filter system, a small central air conditioning system, unidirectional airflow, and a well-type return air system. The change room and air shower room for the purification room utilize an automatic human sensing system.

4. A Class 3 (P3) sterile laboratory, in addition to the features of a Class 2 sterile room, is equipped with electronic interlocked doors, interlocked transfer window doors, epoxy resin self-leveling floors, and wastewater disinfection facilities.

5. Equipped with a Class II biological safety cabinet; both the laboratory and buffer room are under negative pressure, with the relative pressure in the laboratory ranging from -30Pa to -40Pa, and the relative pressure in the buffer room of the clean room from -15Pa to -20Pa.

Biological Safety Laboratory Design Layout:

1. Safety: High-toxicity and highly infectious professional laboratories should be isolated from office areas, forming independent or relatively independent zones; laboratories for pathogenic microorganisms should be located in areas with minimal personnel traffic (preferably newly established as independent facilities).

2. Location: Generally, standard laboratories have no special requirements; high-level biosafety laboratories should comply with national standards.

3. Flow: Transition from a safe, low-toxic laboratory to a highly toxic and highly infectious laboratory. Highly infectious laboratories should be located away from frequently occupied areas and be situated at the end of the building.

4. Isolation: Ventilation system layout: Clean and contaminated areas, Maintenance structure: Isolated maintenance structure, Physical suppression equipment: Safety cabinets, negative pressure ventilation cabinets, etc.

5. Actual Height: Building floor height: 3.5~4.0M; Internal clear height: Cleanroom: 2.5~2.6M; Biosafety Laboratory: 2.5~2.6M; General Laboratory: 2.7~2.8M; Equipment floor height (technical mezzanine): 1.2~1.5M.

6. Room Module: Width 3.5~4.0M, Net Depth: 6~9M, 7~8M is ideal.

7. Corridor and Door Width: Corridor: 1.6~2.0M, Door: 1.1~1.5M, with space for equipment doors.

8. Keep pedestrian and logistics pathways separate. Separate entry and exit for people and goods, as well as clean and contaminated items.

9. Establish specialized laboratories for HIV, PCR, normal cells, serum immunology, animals, and radiology per project, creating a rational zoning and layout.

Biosecurity Laboratory Protection:

Biosecurity laboratories can isolate the experimental contamination area from other clean zones through physical separation measures such as zoning. Additionally, by organizing air flow, the lab can establish a unidirectional airflow (negative pressure gradient), where air flows from the clean zones to the contamination area, effectively preventing the leakage of infectious agents.

Sterile Laboratory (Sterile Room, Sterile Chamber, Lab) Equipment Materials:

Air Shower Room Clean Bench Transfer Hopper Product Air Shower Room Clean Sampling Cart FFU (Fan Filter Unit) High-Efficiency Supply Air Opening Cleaned Door and Window

Construction standards for sterile laboratories (sterile rooms, sterile chambers, labs):

Meets BSL-1 laboratory construction requirements.

2. The lab entrance should be lockable and automatically close. The lab door should have a viewing window.

3. There should be ample storage space for items that are easy to access. Additionally, dedicated storage space for long-term use should be available in the laboratory work area.

4. Special work uniforms should be worn in the laboratory; latex gloves must be worn.

5. Personal clothing storage should be provided in the laboratory work area.

6. High-pressure steam sterilizers should be equipped in all the buildings of the laboratory, and regular inspections and verifications should be conducted to ensure compliance with requirements.

7. A biological safety cabinet should be equipped in the laboratory.

8. Eye wash facilities should be provided, with emergency shower equipment available if needed.

9. Mechanical ventilation should be prioritized; if natural ventilation through windows is used, insect-proof screens should be installed.

10. Laboratory exports should have identifiable markings in the dark.

11. Reliable power supply and emergency lighting are available. In case of need, essential equipment such as incubators, biological safety cabinets, refrigerators, etc., should be equipped with backup power.