Andy Pye looks at product personalisation and how traceability and regulation are critical to its success.

Traditionally, we look at automation as a means of making high volume manufacturing processes more efficient. But paradoxically, one of the welcome side-effects of increasing manufacturing automation is greater flexibility of production lines. This makes them able to produce smaller and smaller batches of product with minimal changeover times.

So taking smaller and smaller batches to the ultimate level, what are the possibilities for manufacturing batch sizes of just one? And why would you?

Product personalisation – or produce-to-order manufacturing – is the idea of customising a product range down to a batch number of a single item, specifically aimed at a particular customer. Hundreds of thousands – perhaps even millions – of unique items. It depends crucially on the quick changeover capability that automation provides.

Of course, this has already arrived by stealth: we are getting acquainted with the idea of make-to-order in the automotive sector, while print-to-order publishing is another example – we order a book and then it is printed! Mass personalisation is gaining popularity, with – according to a recent UK survey conducted by Deloitte LLP – more than 36% of consumers reporting they are interested in personalised products or services. The survey also reveals that over 40% of respondents between the ages of 16 and 30 are attracted to personalised goods and services, and 71% of these stated they would be prepared to pay a premium price.

For different reasons, product personalisation is also emerging in the pharmaceutical industry, where individual packages of drugs can be tailored to an individual patient.

Personalised tablets could be designed to release drugs at the same rate for a period of time, or in pulses at regular intervals, in sync with the biological cycles of the human body. Physicians could produce customised pills on the spot for patients, or in mass production settings by pharmaceutical companies. Here, production lines making personalised medicines would feature automated inspection, sorting and tracking of both the item and an aggregated package for despatch, using machine-readable alphanumeric codes. At the same time, a personalised electronic leaflet would be printed for the patient, containing the instructions for use.

In the food industry, new tastes are arising due to health consciousness and cost. We now have organic, gluten-free, sugar-free, low-fat, high-fibre, low-sodium, and caffeine-free variants of many products. And the desire of food firms and retailers to supply a broadening range of portion sizes and packaging formats (including fridge packs and club-store sizes), while consumers are seeking smaller-quantity packs that meet low-budgets, is also driving product diversification.

High profile product recalls, and greater emphasis on food safety are also driving improved product marking within the food and beverage industry. There is increasing expectation of consumers to be better informed on the food and drink we consume. This is reflected not just in sell-by and use-by dates, but information on allergens, nutritional values, producer details and country of origin, to name a few.

What these developments have in common is a demand for greater production line flexibility: individual customer requests are turned into individual production batch orders, each individually manufactured and packaged.

One technology which is made for flexibility in automated manufacture is robotics, a natural for consistency, accuracy and electronic data recording. Robotic automation enables the parameters of a processing system to be adjusted with a quick change of menu options on a control panel, enabling to smaller and smaller batch numbers to be cost-effective.

Modules within automated machines can set themselves up rapidly and automatically (self-configuring), including the necessary consistency checks and initialisation steps. In this way, they have the flexibility required to adapt inspection to different sizes, containers and marketing programmes and eliminate human error, and so offer further benefits for shorter, faster product runs.

At a corporate level, to achieve personalisation, connecting all the relevant IT systems is mandatory – not just the manufacturing line, but also the business IT domain, from electronic order entry to production planning and through to manufacturing and shipment. Standardised interfaces and integrated programming and control throughout all these levels are needed for efficient data exchange.

Product traceability is central to product personalisation, meaning systematic recording of service information, production data and documentation. Electronic audit trails must be provided for changes to critical parameters. Change control procedures should also be available. Among the many requirements, almost all regulations worldwide require the validation of processes and the qualification of supporting equipment, including computerised systems, packaging processes and data security, especially when gaining access through another system, such as SCADA/MES.

The standards and guidelines applicable to automation in both the pharmaceutical and food and beverage sectors are in fact extensive. In Europe, EU Directives are converted into national laws by the authorities of the individual countries. The looming shadow of Brexit means that additional uncertainty in this area currently prevails.

Pharmaceutical regulations also vary across different industry sectors: finished products, active ingredients, medical devices, biological products, blood products, vaccines, each having their own set of regulations, variable country by country.

Following this lead, standards are steadily being adopted within the food and beverage industry for identifying items, locations, shipments, assets and associated information, as well as enabling data to be shared between the different parties in the supply chain. The GS1 standard is steadily being adopted, providing a globally recognised framework for product traceability.

Specific rules applicable for the Food, Drug and Cosmetic industries in the US are managed by the FDA (Food and Drug Administration), and are covered in the Title 21 of the US CFR (Code of Federal Regulations). Good Manufacturing Practice (GMP) rules in the European Union are published as the EudraLex. The EU rules largely overlap with the USA CFR regulations although conforming with one set of rules does not necessarily mean you conform with the other