Crossing the boundaries

Roger Trew, European development advisor at ISPE, the International Society for Pharmaceutical Engineering, gives his personal view on how the pharmaceutical and food industries can benefit from each others technology through dialogue

As an engineer with a manufacturing background I was surprised to see an example of efficiency improvements I had first seen employed two decades previously in an engineering environment now being used in the pharmaceutical arena. It had taken some 20 years for this concept to jump from one industry to another, and for someone thinking outside the box to suggest the 'new' application.

That is 15 years too long to wait for potential savings in what is typically perceived as an expensive industry, and it probably happened only as a result of pressure to reduce product cost to the world markets combined with just in time concepts and the savings these bring.

concept not new

One of the first things I discovered on joining the pharma industry, apart from the meaning and importance of cGMP, was that the sterile room design and operating conditions were mostly imported from the electronics industry, so the concept of learning from other industries is by no means new.

I also found that when recruiting new engineers there was a lot to be learnt from someone not familiar with pharmaceutical operations, and that problems and technology, while dissimilar, can have an applicability in the pharmaceutical environment.

Occasionally new technology will not be embraced in the pharma industry perhaps because of the capital cost involved or, more often, because of the perceived risks associated with what are seen by many as excessive validation costs. The impact of new technology on production, and the related training needs, is another important consideration. Although 'more of the same please' may be the safest and quickest route to replacing worn out equipment, it is not always the most effective route in the longer term.

One other, more sensitive reason for not implementing change has sometimes been the belief that the regulatory bodies have themselves not embraced the changes and have been 'difficult' when challenging the validation work for the new technique or technology.

This apparent problem can often be overcome by improving communication between manufacturer and regulator, as can be seen very recently from the US FDA's whole-hearted support for, and involvement in the Process Analytical Technologies (PAT) concept, which should improve time to market and product cost, as well as quality.

With drugs valued at £60-150bn coming off patent over the next few years, pharmaceutical companies are seeking new blockbuster products and wanting them not only faster but also more efficiently manufactured. This seems as good a reason as any to search for the most cost-effective and efficient methods of manufacturing pharmaceutical products, from whatever source.

areas of synergy

So why not the cost-conscious food industry, where there are many areas of synergy with the pharmaceutical sector and, I am sure, cost-efficient manufacturing methods.

Two important reasons stand out in my mind as to why the two industries could benefit from talking to each other:

The pharmaceutical industry is developing more sophisticated and complex medicines and manufacturing them using high tech equipment, having invested heavily in its development, commissioning and validation. Systems monitoring for these processes will soon be employing electronic and NIR analytical technology, which may be of interest to the food processing industry - if not now then certainly in the future.

The food industry, after a number of health scares, particularly concerning the use of chemical and some natural preservatives, is being forced to find other ways of achieving the extended shelf life demanded by consumers. Many of the solutions are using technology common to the pharma industry, such as manufacturing under sterile or aseptic conditions, and packaging under modified atmospheres to minimise bacterial contamination.

similar standards

Similar manufacturing standards and room and equipment specifications mean similar validation regimes being applicable to areas of the food industry as never before. I see only benefits coming to both industries out of closer discussion and co-operation - often approaching a problem from another direction provides a different and perhaps more cost-effective solution.

Product traceability is another common area of development. BSE has highlighted the need to be able to trace the origins of packs of meat 'from farm to fork', while the threat of parallel imports has driven the pharmaceutical industry to find novel ways of uniquely identifying individual packs of medicinal products to track the movements of product around the world and reduce, if not eliminate, grey imports.

Historically the food industry has been perceived as one that has had to work efficiently and cost effectively to maintain a competitive edge. Packaging has, I believe, played a significant role in establishing a food product with the general public. The industry has invested a lot of time and energy in pack design; it has also more recently had to respond to a need for a higher degree of tamper evidence for products targeted by cranks and black mailers. The pharmaceutical industry has had to contend with similar problems, but could also learn how to improve its packaging efficiency levels.

There is of course one other very important link between these two industries, and that is the impact of the regulatory agencies.

The pharmaceutical industry has always been a highly regulated environment and has long had to work closely with the FDA, the Medicines Control Agency (MCA), and now the European Medicines Evaluation Agency (EMEA), but this is still an area that causes major anxiety to many pharmaceutical companies.

It may be that the Food Standards Agency (FSA) will operate differently, but there are already a whole host of new regulations and guidance with which the food industry has to comply that have developed since the FSA's formation in 2000.

A couple of ways of achieving the necessary expertise come immediately to mind. The acquisition or employment of experienced professionals with the requisite knowledge and background to apply the various techniques in each industry is clearly one way to address the problem.

With the changing shape of the operations side of the pharmaceutical industry, there is already a huge reservoir of resource available. Many engineers and production professionals with a vast knowledge of the validation of clean and sterile manufacturing areas, and the associated equipment, are leaving the industry, and either retiring, going into independent consultancy or joining the engineering services sector - and many of these already work in both sectors.

Alternatively, the establishment of a pharmaceutical/food discussion forum could perhaps provide a route through which topics of common interest could be openly discussed.

For example, any machine that has to guarantee to provide a sterilising cycle is probably controlled by an electronic and automated system that must be fully and properly validated, and has also to be regularly and traceably calibrated. This can be better guaranteed by applying a consistent methodology to this process, as recommended in the Good Automated Manufacturing Practice (GAMP) Guide on System Validation and the GAMP Calibration Management Guide; the pharmaceutical industry already has a recognised rationale for validated systems.

The food industry may already use this validation strategy for its automated equipment, particularly where sterilisation and high levels of hygiene are demanded, but if not, then here is a ready made, proven strategy available.

A discussion forum, if it is to work to everybody's advantage, will depend on the willingness of companies and individuals to share knowledge and information. But as knowledge is power, and perhaps represents a competitive advantage, this route may not be so easy. ISPE has, through its membership, been instrumental in drafting a series of Baseline Guides that identify the basic essentials necessary in meeting regulatory requirements for facility design, as well as water and clean steam, technology transfer, commissioning and qualification, automated equipment validation and calibration management, among others.

With food processing equipment having been designed, in many cases, by the same equipment manufacturers, the electronic control systems will no doubt be similar if not identical, and will, if controlling a sterilising or clean process, need validation and regular calibration. Discussions between food and pharma on best practices and procedures could be beneficial to both.

common ground

One initiative that has been developed in the food industry by the European Hygienic Engineering and Design Group (EHEDG) is the publication of a series of Hygienic Equipment Design Standards. Again, I see this as common ground where the pharmaceutical industry can learn from another industry's initiative and knowledge.

My experience has shown that there is always something to learn from another's viewpoint, and why not one from another industry? TOTAL in March 2004 is the perfect opportunity to encourage the movers and shakers in these industries to get together, listen to what is new and discuss some of their current - and perhaps common - problems.

Meeting on common ground

ISPE will be hosting a number of seminars and workshops during the TOTAL exhibition in areas that are perceived to be current hot topics, in some cases common to both industries. The objective will be to provide a relaxed atmosphere in which peer groups from both industries can meet, discuss common problems and solutions, and discover alternative ways of doing business that will be advantageous to all.