Why Containment solutions need a mock-up trial?

“You can fix it now on the Drawing board with an eraser, or you can fix it later on the Installation site with a sledgehammer.”
-Frank Lloyd Wright

MythBusters – A show aired on Discovery Channel, was one of my favourite Television shows during my childhood. This show was all about testing science to prove or disapprove old myths using crazy experiments.

Many of those experiments were small and simple to execute, and there were a few large and expensive (exciting!) to carry out. For such large scale experiments, the makers of the show created a demo of the setup before executing the real experiment.

I kept wondering why for every big experiment, they wasted time on making a Demo/Mock-up of the setup instead of carrying out an actual large scale experiment directly. Not only would it save time, but they could also have conducted more experiments in that one-hour timeframe.

Subsequently, during my engineering course, I was introduced to the concept of Dummy Mock-up, Ergonomics & Prototyping – how it helps engineers to test the design before executing it to fabrication to save the hassles of rework & thus saving time & money.

I had my very own Eureka moment! If Mythbusters had skipped on making a Demo Unit of those large scale experiments, they could have never been sure that their setup would even work to the desired outcome. Moreover, when a product or system works in coordination with a human, it has to be more than just “working.” The ease and comfort of the operator are essential to avoid fatigue during the process.

This leads me to ask you a question: Have you wondered why your mobile phone has rounded edges? If your phone had pointed edges, it might have caused stress and fatigue to the hand holding a phone. A typical example to explain “Ergonomics”; the science of understanding and making a product fit the user’s needs, to reduce discomfort and increase efficiency and productivity of the end-user.

Why am I discussing Mythbusters and Engineering days; how is it linked to the Isolation Systems? Clients often ask us about Mock-up study. They are curious to know if it is necessary, or we can skip the mock-up stage to expedite delivery.

Here is my take on why on Mock-up trials; A Mock-up has always been an integral part of designing a project, be it any industry. Mock-up’s offer us clarity about the end product.

As we discussed in some of the previous blogs, an Isolator is nothing but a Material Handling Device. The Isolator acts as a barrier while carrying out the intended pharmaceutical process. The process carried out inside an Isolator might be varied – from a sampling of API to capsule filling operation or even API Reaction & Drying. All of the above activities require frequent human interaction. Thus containment systems must be as convenient and easy to use for the operator as mechanically possible while still maintaining the containment integrity.

Thus only relying on the Engineering Drawing to design such a critical material handling device does not guarantee a perfect outcome as:
1. Customisation for containment solutions will depend on the designated process to be carried out.
2. The operational height of the Isolator systems would differ depending on the region/ country of the operator.
3. Customer’s usage of utilities like spray guns and holding racks will have to be prioritised while designing the containment systems.

Manufacturing the outcome directly (without the mock-up) – i.e. the SS isolator, only to discover operational issues mentioned below can cause not only serious complications but also delivery issues like delay in production timelines ultimately affecting customer relationships:
• Glove port is not accessible
• Process machine is difficult to operate from glove port
• An operator is unable to access isolator systems due to height – it is too high or too low
• Material transfer is difficult
• Glass visibility issues inside the Isolator

Fabtech recommends an ergonomic assessment, an essential aspect of design engineering when designing an Isolator System to avoid the haphazard process mentioned above.

A life-size wooden model is created based on the approved design, to test operations along with the process tools to be carried out during the actual manufacturing process and study improvements with the operator & process in mind. This assessment helps us to understand if an operator can carry out daily tasks comfortably and safely with adherence to quality and corrections, if any, required for mock-up to avoid operator fatgue or injury (exerting postures) while working on containment solutions. This activity requires dedicated time from the customer and team for corrections and reworking changes during the Mock-up phase, thereby saving costs and avoiding delays to manufacture of Isolator systems.

What if the customer wants to skip Mock-up?

We have created a scenario to understand this situation. Let’s assume a customer, ABC Pharma based in the Netherlands requires a sampling dispensing Isolator and approaches an Indian vendor, who doesn’t offer a Mock-up study facility.

The vendor designs a standard conceptual GA based on his previous experiences & human ergonomic data of his local region. The customer approves design based on concept and function and vendor manufactures the Isolator based on Approved GA Drawing. This manufacturing cycle ends with the vendor performing Internal Factory Acceptance Tests that qualify the Isolator.

The customer is invited for a final FAT after successful completion of internal FAT. He is shocked to notice that the height of Isolator is too small for the operator as the average Dutch male (approx 6 ft tall), causing stress even to insert his hand into the glove port. In addition to this, the operator faces an issue with the length of gloves and depth of Isolator. He is unable to operate the Isolator comfortably due to long arms making the usage of the Isolator cumbersome.

The outcome of this manufacturing activity: Delay and increase in cost to the customer even though the product was manufactured well within time-limit straining the customer-vendor relationship.

Introducing a mock trial stage after drawing approval may only increase by 7-10 days; however, it ensures a reliable final product, building up project confidence, avoiding additional delay and increased costs benefiting both the parties.

Flow Chart of the Isolator Design:

Once a customer places an order for containment solutions, we create and present a design concept based on customer requirements and criticalities. We compile the General Assembly drawing and Piping and Instrumentation diagram based on the design concept.

A wooden Mock-up model is created after necessary approvals, which is to the scale (dimensions are a replica of the actual Isolator). We invite the customer to our Isolator Manufacturing facility that may include a Production/Process in-charge and the Future Isolator operator. Our team of design, production, automation, and QA/QC engineers take the customer through the Mock-up process.

The customer minutely examines the Mock-up model/ prototype based on the
• Process flow
• Reachability
• Overall dimensional check
• Compatibility with the customer’s room layout
• Manoeuvrability (for mobile Isolators)
• Check glove-port position
• Operator operational fatigue

If the Process Machine is available, then it is placed inside the Mock-up to check the Operation through Glove-Ports. In case of unavailability of the process machine, a wooden model is created and placed inside the Isolator. Frequently used components (pumps, fittings, scales) are used in the Mock-up to allow the weight, size, and handling of the machine. The arrangements of necessary Isolator parts (air filters, fans, ducts, metrological sensors) along with the location of the containment solutions are taken into consideration. During this stage, the glove positions can be modified to suit the requirements of the average operator’s comfort and process needs.

The whole process is well-documented to include corrections and modifications in the General Assembly Drawing and Piping and Instrumentation diagram and presented to the customer for final approval. Once the final approval is received, the manufacturing process is initiated.

WOODEN MOCK-UP OF ISOLATOR

FINAL FABRICATED ISOLATOR