Breaching the barriers of communication

Shout it from the rooftops - if you want to keep up to date with lab automation technology, the key is communication with other industries

Innovative automation has been key to the rapid technological development in many industries including the nuclear, petrochemical and pharmaceutical sectors. The communication between suppliers of these industries and the transfer of technical or regulatory know-how has proved invaluable.

In the late 1980s and early 1990s the validation of automated systems for pharmaceutical production took on a much greater importance. Systems delivered to the pharmaceutical industry were increasing in complexity as the technology advanced in line with other industries. As a result, the pharmaceutical industry and its regulators were becoming more aware that these systems would require a highly disciplined approach to validation. Subsequently, the GAMP (Good Automated Manufacturing Practice) forum was set up to tackle the issues being presented, and it was quickly recognised that guidelines would have to be produced to help both the pharmaceutical companies and their suppliers.

Automation suppliers had previously been delivering to other stringently regulated industries, i.e. the nuclear and petrochemical sectors, for a number of years. Such industry sectors have always set tough criteria, demanding the most advanced automation which is not only mechanically robust but also meets the rigorous safety requirements set by industry regulators. Customers within these established industries have always required a high level of documentation and validatory evidence encompassing functional design through to software coding, and the traceability of all elements within this cycle. With input from these specialist suppliers, forum members from other key industries, and of course the experts within the pharma industry itself (such as the International Society of Pharmaceutical Engineering), the GAMP forum could set about producing a comprehensive set of guidelines. These would enable all pharmaceutical manufacturers and their suppliers to produce automated systems using the required next generation technology with the correct level of documentation and traceability for their regulators, ensuring compliance with the FDA’s GXP regulations.

To date GAMP has proved very successful and one of the reasons it has been adopted across the board within the pharma industry, is that it follows a typical project lifecycle that would not be dissimilar to a project in the nuclear, telecommunications or even civil engineering world. Most supplier companies breaking into the pharmaceutical industry for the first time will generally understand the principles and rules of GAMP. A professional automation outfit supplying goods and services to the nuclear industry would have already been following the 5 project stages; planning and specification, design and construction, installation and testing, acceptance testing and finally operation. During the design and construction stage they will have to produce a design from user requirements that will include a functional specification, software design specification and hardware design specification. A company new to the pharmaceutical industry would not have too much difficulty understanding the intricacies of GAMP and where the pharmaceutical requirements may differ slightly, suppliers are usually familiar with a similar process in their own industry sector.

Evolving technologies
By accepting new systems from different industry customers the supplier will expand his product or technology portfolio and subsequently filter out the bad systems where possible, as they may not be suitable at a commercial or product level.

An area which commonly experiences technology transfer, and is carried out in laboratories spanning numerous industry types, is formulations science. The formulations science process involves carrying out numerous reactions with an array of constituents in order to obtain and identify new and useful products. Experimental data from multiple reaction types are stored to record all experimental conditions and thus enable their application to future formulation experiments. A number of technologies are used to help increase the throughput such as automated liquid dispensers, powder handlers, mini reactors, and mixers. These technologies are available as products, and generally help to automate and increase the throughput of selected stages within the overall process. However, due to the varying nature of the formulations science process, there are quite often areas that fall outside the scope of current automated products. For example, having to handle highly viscous materials or incorporating special filtering processes. In such cases a bespoke automated solution would be required and experience gathered from working within other industry sectors will assist in its development. This then becomes a design and build process, much like that carried out when developing automated production or process systems for full scale manufacturing, as essentially the solution will be a miniature manufacturing system, with more variability. This also brings with it the challenge of designing and building a system to numerous standards and directives that govern how various materials can be handled, how machinery is designed and built, and most importantly the safety issues surrounding the operation of such machinery. Within the pharmaceutical industry in particular there can be specific customer requirements for traceability: how the final solution is designed, built, and tested. This involves the preparation, supply and coordination of a large amount of documentation.

The project management tool ‘Prince 2’ (Projects in Controlled Environments 2) is another good example of transfer of successful technology. Prince 2 was developed for complex IT projects within the telecommunications industry and is a process-based approach to project management. Each process is identified and defined within the project highlighting key inputs, outputs and objectives. The success of Prince 2 comes from its approach to being system-driven, i.e. project plans are focused on delivering a system and not simply trying to achieve a multitude of (sometimes) incomprehensible tasks. Simplistically, in the past, a supplier has been asked by a customer from the petrochemical sector, for example, to use this as the project management tool. The supplier is impressed with its functionality and as long as it is fit for purpose will continue to use it across other industry types.

Shout all about it! Communication is key to improving knowledge

Technology transfer between industries often occurs as a result of an iteration of processes involving both the supplier and the customer over a number of years. Eventually the final iteration becomes the standard and then the de facto - GAMP is starting to fit into this scenario. The most basic example of this is as follows; if you are running a software application, where do you expect to see the File tab? In the early eighties when software engineers were starting to code user interfaces for word processors, spreadsheets etc, toolbars would be anywhere the engineer decided to put them. Menu bars could be seen at the bottom or side and the File tab could be anywhere or hidden under another function key. A word processor used to rely on a selection of keys/commands to save your document. However, today the software industry has mostly standardised, a large part due to Microsoft and others, and the tool bar is now set up so everyone, experienced or new users alike, can quickly use a new piece of software.

The technical know-how
As technologies have evolved across a broad range of industry sectors it has become apparent that communication between these, in either direction, can be mutually beneficial. Where industries, such as the pharmaceutical, petrochemical and nuclear industry, share common requirements, albeit on different scales (i.e. for safety or contamination prevention), there is much that can be learnt.  Whether it be for the adoption and implementation of specific regulatory guidelines, such as GAMP within the pharmaceutical industry, or for the incorporation of highly relevant technologies or components, it is important that we endeavour to breach the natural barriers between industries to enable us to push the boundaries of innovative technology. In order to do this, industries must push both themselves and their suppliers to share technical and regulatory knowledge. Only through doing this can we fully realise the potential and maximise our capabilities across the board.

By Lars Lind-Hansen, Sales Manager, Astech Projects