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Features
The cell therapy facility of the National Institute for Cancer Research of Genoa will be fully operational in few months.
The facility consists of three laboratories, outfitted with biosafety cabinets, incubators, centrifuges, microscopes, and other equipment needed for tissue culture. Cross-contamination between various spaces is minimized by standard operating procedures and an electronic door monitoring system.
Consistent with GMP regulations, each laboratory has its own dedicated equipment, so that individual patient cell manipulations and/or cultures can be physically isolated. Fully redundant air handling systems are used to maintain class 10,000 (ISO7) air supplies. These rooms were built using clean room construction standards, and are routinely monitored for viable and nonviable air particulate counts and surface microbial contamination. All operations requiring open manipulations of patient tissues are carried out in class 100 air quality biological safety cabinets. Facility access is restricted to authorized, trained personnel.
European Good Manufacturing Practices
Medicinal products for human and veterinary use: Good manufacturing
practices: Basic requirements and Annexes http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm
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