10 Frequently Asked Questions on Comecer Isolation Technology Solutions for Regenerative Medicine

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At the TERMIS-EU event this year, Comecer presented new Isolation Technology Solutions for Tissue Engineering and Regenerative Medicine. Visitors at our stand were curious to learn more about them, and these are 10 of the most common questions they asked, with the answers provided by our technical experts.

External view of our isolator scale model on display at TERMIS

What are the advantages of this Isolation Technology Solution compared to a clean room?

In general, the adoption of Isolation Technology for aseptic processing has the following advantages in terms of quality of the treated product:

• It offers a sealed Grade A environment for the entire process
• The isolator can be designed and manufactured to match customer requirements completely in terms of: process requirements, layout, equipment integration, material flow and handling, personnel flow and number, ergonomics, automation, and safety
• An isolator can dramatically lower the risk of external and cross contamination, being a sealed environment with no direct human access to the critical aseptic zone.

There is also a long list of advantages that influence operational costs. In fact, proper isolators designed for GMP manufacturing can be installed in a Grade D environment, and this offers considerable advantages:

• It provides a considerable reduction in space requirements, simplifying facility layout
• It enables a huge saving in energy and utilities consumption
• It enables a cost reduction for facility maintenance (equipment, HVAC, utilities, energy, waste)
• All the operations connected with personnel and materials required to access a traditional clean room in Grade B are no longer necessary (dressing procedure, materials cost and management, time).

Is this a suitable technology to make GMP production in a normal lab?

Yes, with an Isolation Technology approach the GMP compliancy of the critical manufacturing environment is confined within the isolator so the production can take place in a Grade D area.

How are the primary cells introduced in the workstation?

Different systems can be adopted. The most common is via a dedicated transfer hatch or, before cells culture operations, with isolator open doors. Other systems such as rapid transfer ports can be adopted after an assessment of the incoming packaging type.

Is it possible to carry out a process requiring the use of a 10-liter bottle to be incubated?

Yes, there are different incubators size available (from 27l to 400l) and for each size the internal volume arrangement as well as access doors can be adapted and customized based on the material to be incubated.

Can two operators work together on the same product?

Yes. One, two or more operators can work together, as the isolator can be designed to allow one or more working positions.

Is it possible to integrate different small incubators in order to set them at different temperatures? If so, can I then decontaminate the internal part of the chamber without affecting the incubator internal volume?

Yes, the integrated incubators can be chosen with different sizes and independent from each other. In addition, the access doors to the incubator from the internal isolator volume have an airtight design in order to assure the complete separation of the internal incubator volume, if required for separate decontamination.

Is laminar airflow in the isolator a requirement?

Even if laminar airflow is not a strict requirement in sealed environments in order to reach Grade A (see Annex 1 of GMP), when the process is strictly manual the adoption of laminar airflow (also at lower speed than the usual 0,45 m/s) can improve the assurance of sterility. However, the decision should also be made based on the working environment dimension and process specifics.

Why are the isolators made of stainless steel and not epoxy painted steel or plastic material?

The use of stainless steel is driven by cleanability requirements at a sanitary level. Nobody would like to see a surgeon operate with tools made of epoxy painted steel or some type of plastic. In addition, durability of the material is one of the requirements that results in the selection of stainless steel for aseptic processing where decontaminating agents are used frequently. Stainless steel type 316L is the best option for the isolator shelf since it assures no corrosion in the welding lines.

How is the internal volume of an isolator decontaminated?

An automated decontamination process is strongly recommended for GMP production to reach the 6Log reduction required for the aseptic environment where the sterile product is handled. Compared to a manual process (spraying the sporicidal agent), an automated process is easily validated and assures the repeatability of the decontamination cycle. The most common technology today is with vaporized H₂O₂. This automated decontamination system is integrated on board our isolators.

Is it possible to have a microscope available inside the isolator, and how would I use it?

Yes, a microscope can be integrated, but with a remote camera option. In this way, the images are transferred to a laptop or screen outside the isolator, either close to the operator or with a viewing window behind the isolator back wall.

For further information:

You can find additional details on these solutions on our website at this link: http://www.comecer.com/isolation/isolator-glove-boxes/regenerative-medicine/

You will be able to watch a video and download product brochure, case study and white paper.

If you have other questions, do not hesitate to get in touch so we can answer your questions personally and add them to this list.