According to the technological requirements of the IVF area, cleanroom levels are distributed as D, C, B (GMP-WHO, GMP-EU) with requirements for the quantity of particles in the air.
Specifically:
– IVF Lab, Embryo and Sperm Storage Room: Class 1000 (ISO 6)
– Clean Equipment Storage, Procedural Room (TESE Operating Room, Oocyte Retrieval Room, Embryo Transfer Room): Class 10,000 (ISO 7)
– Clean Corridor Area: Class 100,000 (ISO 8)
– 0.5 ppm < VOCs < 1 ppm: Allows for reasonable embryo and pregnancy development rates, but still results in high miscarriage rates. - 0 ppm < VOCs < 0.2 ppm: Ideally, the concentration should be as close to 0 ppm as possible for higher rates of embryo and pregnancy development.
Temperature and humidity within the room must be constantly controlled with minimal deviation to ensure the optimal conditions for embryo culture and development during in vitro fertilization. For the cleanliness level of the IVF area, the temperature and humidity are maintained at 23°C and 60% ± 10%.
Embryos are extremely sensitive to external factors germ of life, so besides requirements for temperature, humidity, CO2 levels,… noise level is also an important factor in minimizing stress on embryos. When designing an HVAC system to reduce noise for the system, there are several methods:
– Wrap a ssoundproofing insulation around the air ducts from the Air Handling Unit (AHU) using materials such as fiberglass cloth, mineral wool, or vulcanized rubber.
– Soundproof the room where the AHU is placed to minimize noise generated by the equipment.
– The soundproofing system for the AHU room may include: a sound-absorbing foam layer, white silver fiberglass fabric layer, and a perforated stainless steel layer.
According to TCVN 7114-1:2008, the Vietnamese standard for hospital lighting, the recommended illumination level for hospitals is around 500 lux.
In areas classified by cleanliness levels, microbial levels need to be controlled during operation using various methods such as air sampling, agar plate exposure, surface sampling, ….