NP870: An epochal incubator specialized for cell production
NeXCell P870
CO2 incubators were originally used for research, but as the market demands of regenerative medicine and cell therapy rises, the cases of being operated for manufacturing purposes are increasing. However, the current products are not necessarily optimized for operation in specific cell processing facilities (CPC / CPF) based on GMP (Good Manufacturing Practice). We have developed a CO2 incubator as “a device for cell production” that satisfies the requirements of manufacturability, reliability and reduced management costs, which are based on many years of experience and knowledge.
Improve productivity and Expand a range of applications
Cell production has a wide variety of culture method and scale. Until now, middle-sized products with a chamber volume of 150 to 180 L have often been used for cell production in specific cell processing facilities. NeXCell P870 (NP870) is the largest class of model with a chamber volume of 870L. It has approximately 5 times the capacity of middle-sized products, and can significantly improve productivity (= size and quantity of culture vessels).
Excellent temperature uniformity and recovery performance
Conventionally, since large CO2 incubators have the huge size of chamber, they have had various issues such as temperature uniformity, recovery performance when opening and closing doors, and excessive condensation inside the chamber due to humidification. “Despite being large, achieve performance and quality comparable to middle size” We worked on the theme of not compromising on performance in the development stage of NP870. After various trials and errors, we achieved best-in-class performance with our own air circulation system and heater control technology.
Suitable for CellSTACK / Cell Factory demands
As an efficient way for scale up of adherent cell culture, demand for multi-layer culture flask (stack plates) such as CellSTACK (Corning) and Cell Factory (ThermoFisher Scientific) is increasing. In the case of a 10-layer vessel (CF10 / CS10), the weight of the vessel including the culture medium is about 5 kg. The reinforced shelf for NP870 can hold six 10-layer vessels. The shelf has a rugged design that guarantees robustness and flatness without sagging even by loads up to 30kg or more. In addition, the sophisticated temperature control and air circulation system achieves the excellent temperature uniformity and recovery performance, which is comparable to the no-load condition even when the culture vessel is fully loaded.
Contamination control
The biggest concern of the CO2 incubator is the propagation of mold and various germs, that is to say “contamination”. No matter how much attention you pay, it is an unavoidable problem to bring them in from the installation environment. NP870 comes standard with a special HEPA filter that cleans the circulating atmosphere inside the chamber. This filter using PTFE, which is different from the conventional one, has the property of being able to withstand high humidity with low pressure loss (hydrophobicity). The atmosphere in the chamber reaches ISO class 5 (class 100) cleanliness, equivalent to a safety cabinet or clean bench, in just 10-15 minutes after opening and closing the door. In addition, by using WATERBAG developed by ourselves, the replacement work of humidification water is made easy, and clean operation without dispersing mold and various bacteria of humidification water has become possible.
HEPA filter(left）and WATERBAG(right)
Excellent expandability that can be achieved
In order to meet the demands of various cell production purpose, flexibility that can be used for various applications depending on the culture method is required. Utilizing the large capacity of the NP870, the magnetic stirrer, shaker, and roller apparatus can be installed inside the chamber. Both sides of chamber wall provide large access ports which introduce power cables and sensors.Contributes reduce validation costs
Different from the research usage, costs, especially running costs, are important for manufacturing operations. It is assumed that one of the concerns manufacturing managers have is the cost of IQ (installation qualification) and OQ (operating qualification) at the time of introduction, yearly preventive maintenance work and inspection, and annual validation. NP870 has a culture capacity for five middle-sized incubators. It means, for a typical operation, the cost for five units in every year can become only for one unit, which is that the management cost can be reduced to one-fifth.
Effective use of clean room space
In many cell processing facilities (CPC / CPF), the room where cell processing operations are performed in grade B clean room, and the space is limited. In that space, the area required by equipment, such as CO2 incubators and safety cabinets, is not small. The installation area of NP870 is about 1.5 times as big as a typical middle size. The advantage is obvious even when compared to the example of stacking two middle-sized incubators.
CO2 incubator as a manufacturing equipment for manufacturing sites
