MCCI Модульный Изолятор для Клеточных Культур

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An Isolation Technology Solution for Regenerative Medicine and Tissue Engineering

Isolation Technology in the pharmaceutical industry and in regenerative medicine provides a physical barrier between a process that may have requirements of asepsis and/or toxicity and the external environment. The physical barrier is usually a fully welded enclosure inside which a specific ventilation and filtration strategy allows a controlled atmosphere.

Используется в Технология отделения Регенеративная медицина Для клеточная терапия инкубационные системы
 
Modular Cell Culture Isolator

The adoption of our Modular Cell Culture Isolator within aseptic processing, compared to the same processes performed in standard clean room environments, has clearly demonstrated the advantages of isolation technology. This newly developed generation of  Isolators designed for Regenerative Medicine application allows Biotech centers as well as Tissue Engineering laboratories to continue to make advancements while still operating within the ever restrictive confines of various regulatory bodies (FDA, EUP, USP) and industry guidelines (GMP, PDA).

The demands of the regulatory bodies have not changed, but the acceptable limits have been drastically raised.  With the use of Isolators to integrate the various Regenerative Medicine processes, compliance with these demands is totally and easily attainable and the highest levels of aseptic conditions (Sterility Assurance Levels) and operator safety are guaranteed.

Simultaneously, the operational costs normally associated with traditional clea room use (HVAC, utilities, personnel gowning, etc.) and sterilization cycles of the entire clean room suite are substantially, if not completely, eliminated. This is mainly because Isolators with their own integrated decontamination system are designed for installation in class D environments. This specific product line dedicated to Regenerative Medicine includes a few pre-designed modules to be used for tissue regeneration as well as custom solutions to address the specific requirements in terms of process, layout and expected manufacturing capacity.
The primary goal of this product line is to integrate the entire cell manipulation process within a Class A environment. This requirement of Class A continuity throughout the process is crucial for the sterility of the final product.As far as the characteristics of the Isolator, the design is mainly driven by the GMP and PIC/S as design principle and also by the reference standard and guidelines in aseptic processing within isolation technology.

From this assessment and the large experience in traditional pharmaceutical industry, the following technical features are recommended:

Ventilation Strategy

  • Laminar Airflow equipped with HEPA H14 filter: in aseptic processing, extensive manual operations through gloves can be a major source of particulate, that is why laminar airflow (which also implies higher air volume changes in the enclosure) is preferred since it assures a better “air wash” of the working area
  • Positive pressure
  • H14 exhaust filters: even if not required for a strictly sterile application,  this feature can reduce the risk of cross contamination between adjacent chambers and increase the flexibility in the manipulation of hazardous material inside the isolator.

Ergonomic

  • A MockUp Studio is strongly recommended to assure the operability and comfort during the process execution.

Decontamination

  • H2O2 gas is state of the art for this application, giving better performance when compared to other decontamination solutions
  • Different cycles can be developed for the whole internal volume or only for the transfer hatch, which is used as the transfer port into the clean area.

Controls

  • Viable and Non-Viable continuous monitoring
  • GAMP 5 Software to manage the whole isolator
  • SCADA System for 21 CFR Part11 where requested

Depending on the batch volume needs, a different arrangement of multi-stage modules can be evaluated or alternatively a more compact solution can be adopted where applicable.

If you are interested in this technology, you may wish to read:

Advantages of the Modular Cell Culture Isolator in Regenerative Medicine laboratories

  • Glove Boxes guarantee better safety levels
  • Top class sterilization protocol of the critical areas using VPHP cycle
  • No manual intervention in environmental sanitization brings less risk of human error
  • Better space management with a Glove Box
  • Smaller footprint of the classified areas allows a glove box to be installed in smaller facilities
  • A larger Class A space available, compared to the BSC used in the Cleanroom
  • Total sanitizing costs using a glove box: average cost of 1 litre H2O2 cartridge is 7 Euro. Typical consumption is 1 cartridge per 5 cycles
  • Average running cost of a glove box is one third of a small size clean room
  • With a glove box no sterile gowning needed
  • Time savings for operators
  • Easier validation procedure with a glove box
  • Comparable yearly validation costs and building costs.

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