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Isolation Technology

Modular Cell Culture Isolator (MCCI)

| PRODUCT MANUFACTURER: COMECER

Product Description

Take a closer look at the Modular Cell Culture Isolator (MCCI), manufactured by leading isolation technology provider, Comecer. This isolator is the perfect solution for regenerative medicine and tissue engineering by providing a physical barrier between a process that may have the requirements of asepsis and/or toxicity and the external environment.
The physical barrier is a fully welded enclosure inside which a special ventilation and filtration assemblage allows a controlled atmosphere.

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 a 1-liter 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

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. These isolators allow biotech centers and 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 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 fully and easily attainable and the highest levels of aseptic conditions (Sterility Assurance Levels) and operator safety are guaranteed.

With the MCCI, operational costs normally associated with traditional cleanroom use (HVAC, utilities, personnel gowning, etc.) and sterilization cycles of the entire cleanroom suite are substantially, if not completely, eliminated. This is mainly because isolators in the MCCI range, with their own integrated decontamination system, are designed for installation in Class D environments. This specific product line, along with being dedicated to regenerative medicine, also includes a number of pre-designed modules to be used for tissue regeneration, and custom solutions to address the specific requirements of process, layout and expected manufacturing capacity.

Main Features and Benefits

  • Used in regenerative medicine
  • Used for cell therapies and incubation systems
  • Designed to integrate the entire cell manipulation process within a Class A environment
  • Engineered with the GMP and PIC/S design principle and compliant with reference standards and guidelines in aseptic processing within isolation technology
  • Laminar airflow equipped with HEPA H14 filter
  • 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
  • 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 for just the transfer hatch (used as the transfer port into the clean area)
  • Controls:
    - ­Viable and non-viable continuous monitoring
    - ­­GAMP 5 software to manage the whole isolator
    - ­­Optional SCADA system for 21 CFR Part 11 compliancy
  • MockUp Studio option to assure the operability and comfort during your process execution

Options

  • A customized arrangement of multi-stage modules can be evaluated depending on your batch volume needs
  • A more compact unit can also be customized if required
  • Please speak with a STEQ America team member for more information

Accessories

  • Please speak with a STEQ America team member for more information

Video

Additional Product Model Imagery

MCCI centrifuge

Incubator

Refrigerator

Storage area

Transfer hatch

Viable monitoring

Microscope tissue engineering

STEQ America works with Comecer's worldwide network of services and support

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