Goldilocks and the Three Wares

Once upon a time, a little girl who had a lot to learn, was faced with making a variety of choices, dealing with the consequence of those choices, and ultimately reaping the reward of those choices through trial and error. Her name was Goldilocks.

This 19^th century fairy tale includes themes of finding the ‘best fit’. However, it can also be applied to subjects as diverse as economics, psychology and medicine. It is a story that conveniently allows us to think about our choice for both consumables (porridge) and hardware (the chairs, and ultimately the bed) as they apply to the world of pharmaceutical manufacturing.

Let's start with consumables, the porridge in this story. Unlike the porridge, pharmaceutical processes are normally carefully controlled (including temperature) but upstream of this critical product attribute, we will focus on the approach to the design of the consumable in question. The approach to this also involves choice.

Porridge – Spoilt for Choice!

Making porridge (oatmeal) uses a simple recipe. At its most basic it is two ingredients, oats and milk. But, other ingredients can be added to achieve the preferred flavor. Those from Scotland traditionally would add salt but, sugar, from simple sugar to more fanciful maple syrup or jam, would be a more common addition. Some may add fruit, such as banana (my personal favorite), grated apple or prunes. When you then add in options including types of milk or milk substitutes, or even substituting milk for water, even this basic recipe has a myriad of potential options. Any preference is mostly personal, from plain oats and milk to exotic beef jam porridge with green and red peppers (that’s right, you can have veg and meat in your porridge too!), but it can also be based on previous experiences and we often follow in the paths of those we observe without exploring alternatives.  There is no right or wrong for the ingredients list – the components of the product. We can also then think about the heating method, stove top, microwave, or none, with ‘overnight oats’ not requiring any cooking at all. The number of permutations are immense, to the point where it could be daunting for anyone not familiar with the foodstuff to order a single bowl, and especially problematic for the chef being tasked to stock a kitchen that can cope with every permutation. And this is not even factoring in the possibility that some real skill may be involved to achieve the desired quality product at the end. If Goldilocks was confronted with a well-stocked kitchen, without a clear idea of how to make porridge, her preferred set of ingredients or her preferred temperature, I think we can assume that even if she did try, the story would look very different. She could have discovered she was more of a slow cooker caramel mocha porridge lover after all!

As it was, Goldilocks had a simple choice. In the end, three options were available, one bowl proved to be too hot, one was too cold and one was just right. She ultimately made a choice through trial and error. We will assume that each was created to the personal preference of the family of bears despite their temporary absence.

This is where this analogy diverts from the reality of pharmaceutical processing where the desired attributes of any consumable would never be random and rarely discovered out of good fortune.  But Goldilocks’ simple choice was from a number of pre-prepared options established to meet the needs of a defined audience, the family of bears. This supported rapid progress and satisfied the appetite of a small girl after a couple of false starts.

Let’s imagine a different scenario for Goldilocks. Maybe all three bowls were at the same temperature, and maybe she didn’t like any of them as a result. Without any choice at all, she may not have eaten the porridge, and the story would not progress in the same way. The process would have stopped. Equally, driven by need, she could have eaten the porridge anyway and suffered unnecessary pain from porridge that was actually too hot to eat. In this case, the process may have been forced to adapt to what was available and become compromised in some way as a result.

‘Matching an appropriate level of choice to real world process decisions can be very helpful.’

Matching an appropriate level of choice to real world process decisions can be very helpful. There is a time when an absence of apparent choice in an off-the-shelf solution is appropriate. Similarly, there is a time when a custom development is entirely appropriate. But in the ‘Goldilocks zone’ a broad sweet spot can be achieved if the choices available are carefully designed to fulfil the needs of the majority of users with as few options as possible.

In the context of single-use consumables, standards do exist. Single design options for common tasks. Custom solutions are also possible but can be slower, more costly and come with additional risks. These risks can be controlled with the right systems in place, and it is here that we migrate to the third option where systems can quickly be designed using pre-approved, validated and qualified components. By taking a modular approach.

‘Systems can quickly be designed using pre-approved, validated and qualified components by taking a modular approach.’

Take a Chair

So, let’s now look at hardware, the chair analogy. Goldilocks again had the luxury of experimentation to discover the right fit for her. During early process development, testing does take place for some process technology choices but in the world of technology transfer, experimentation with multiple solutions is rarely possible. It has to be right first time.

If Goldilocks had a solid understanding of engineering principles, she may have been able to identify that the chair, despite being the most comfortable, was not capable of doing the job she wanted it to do. She may have been unaware that the physiology of little girls and baby bears were so different, despite the apparent fit based upon her size. In a similar way, no two processes may be exactly the same, even though they may appear similar, and the absence of relevant knowledge introduces risk of failure. The right engineering solution, underpinned by deep process knowledge can design hardware to maximize the flexibility to allow it to adapt to multiple processes. How would your desired supplier of pharmaceutical technology approach the chair design? Would they supply a one-size-fits-all chair, or as in the story, provide a few sizes, accepting that one might break if the nature of the process demands changed slightly? Would they over-engineer the chairs to reduce failure but at the expense of the space they take up or their comfort? Or could they design a solution that easily adapts to different needs and think innovatively, perhaps with varied seat sizes or leg lengths on a common frame?

Coupled with an optimized number of choices, preconfigured solutions, built using a modular approach, help to expand an equipment sweet spot. This Goldilocks zone provides solutions that are almost the same as custom engineered alternatives. But, by leveraging the knowledge of the manufacturer you lessen the burden and are not required to be expert in every element needed to make the right requests and decisions throughout the lengthy design stage. With the right knowledge, the manufacturer can offer options that deliver exactly what you require from preconfigured, predesigned and proven ready-to-go solutions.

One Last Bedtime Story

Finally, let’s look at the bed in the story.

The best fit in this instance was not one of size or strength but one of comfort. Comfort only achieved from knowing you have made the right choice. Goldilocks had no idea of what might follow but process developers have a very clear vision of what comes next and want to avoid the possibility of any surprises. So here, the comfort factor comes from trust in the provider of the equipment. Pall do not make beds, but I do believe that, if we chose to do so, they would have a proven track record of good sleep with the beds being available in a number of configurations to provide a good night’s sleep for people, and bears, of all sizes and ages.  

To conclude, Goldilocks was able to establish the best choice for her at each stage in her journey through trial and error. While she was spared physical harm, she learned an important life lesson, albeit at the expense of the bears. Some question if she was good or bad to be in that position but to me, I think she was just young, naïve and unaware of how her choices impact on what follows and those around her.

So offering the right choices, and thereby empowering process developers to make the right choices, quickly and with safety is critical to the story of any drug manufacturer, and any quality supplier to the industry. With the right choices comes comfort and take us all one step closer to happy ever after.