Is a mock-up study important in designing an isolator or glove box?

Which features/characteristics should be checked to carry out a proper ergonomic assessment?

Mock-up example

Benefits of a Mock-up Study

When designing an isolator for manual processes, ergonomic assessment is a crucial part of Design Qualification.  The point of the assessment is to test, as accurately as possible, the operations to be performed during real manufacturing with real tools and consumables planned for the specific process, assuring that the operators will be able to perform their tasks in the most comfortable environment, while maintaining an assurance on process quality and safety aspects.

The main purpose, in fact, is to avoid operator fatigue or injury during the process (awkward postures, forceful exertions, static postures or pressure points…) while at the same time to guarantee the correct feasibility of all the process steps. The consequences of neglecting or underestimating this assessment may be irreversible, ultimately causing huge cost and time to rework the already manufactured isolator or, even worse, to affect its usability.

For this reason, it is extremely important that the customer, with the participation of its engineering and operational functions together with the isolator manufacturer, dedicate enough time to this studio. In fact, while the end-user has its knowledge and operation perspective, the experience of the isolator manufacturer will help and suggest possible solutions.

Different isolator manufacturers can use different ways to build a Mock-Up Model, for example using wood, carton, steel, aluminium frames or a combination, and for each material used there are pros and cons. However, it is crucial that the material chosen gives the best flexibility while at the same time provides a good sense of the solid appearance of the equipment.

Comecer’s Mock-up Process

When an organization is interested in a new, custom-built isolator these are the steps we generally follow:

  1. Comecer receives a request for a mock-up model.
  2. Comecer experts meet with the requesting organization and then produce a mock-up based on requirements.
  3. When the mock-up is ready, we organize a client visit to our factory to see the mock-up.
  4. Comecer goes through its Mock-up Checklist (see below) with the client to verify that the model covers all topics appropriately and that all client questions are answered.
  5. Comecer proceeds with production of the custom-built isolator.

To get an idea of the thoroughness of the Comecer Mock-up checklist, we are enclosing a copy below.

Mock-Up Study Preliminary Checklist

Operator Comfort
  • Is the isolator designed for a standing position, a seated position, or both? Is there sufficient space for the knees? Is the stool adequate, with adjustable height?
  • Is the frontal viewing panel inclined? This is usually recommended for better ergonomics.
  • Size and shape of Glove Ports
  • Position of the Glove Ports
Adequate Visibility
  • Is there sufficient lighting in all the chambers?
  • Are there any disturbing light reflections in the normal operating position?
  • Are there any objects that might be introduced that require a special light?
Process Feasibility from Operator Side Work area:

  • Is the operator able to perform all the tasks without affecting the comfort?
  • Can the operator reach all the transfer ports, trays, connectors, etc.?
  • Is the operator able to use the internal integrated equipment, such as scales, vacuum oven, incubators, etc.?

Operator Direct Interface:

  • Does the operator get enough sensitivity with the isolator gloves, given the adequacy and resistance of the material?
Process feasibility from Product Side
  • Is there sufficient space? Does the operator have an idea of how to reorganize the space given the isolator constraints?
  • Is there any step in the process that requires special attention, and is it correctly invested by the laminar airflow?
  • Is any liquid spillage possible? If so, is there a need for an additional tool/shelf/platform?
  • Is the operator able to reach all the internal surfaces? If not, evaluate some cleaning tools.
  • In case “Washing or Cleaning In Place” is applicable, assess the positions of the spray balls and spray guns.
  • Is all the equipment needed for the process washable? Otherwise, how is it handled? If protection is needed, assess the ergonomics to reach the correct protection level (placing bags, removing the equipment, wiping, etc.)
First Level Maintenance Access
  • Filter accessibility (especially in case of containment application)
  • Assure appropriate position and access for maintenance to all the relevant technical areas on board and/or remote.

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