MCCI
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:

• our white paper titled: Sterility and Cross Contamination Challenges in Tissue Engineering and Regenerative Medicine >
• our case history titled: The Redesign of a Tissue Regeneration Laboratory using Isolation Technology for Improved Sterility and Lower Production Costs >
• our last post titled: Isolation Technology in the production of Advanced Therapies Medicinal Products (ATMPs)
• an introduction to Regenerative Medicine on Wikipedia