The costs and benefits of cleanroom engineering

The production of low particle count, contamination-free products in the polymer engineering sector gives business an array of new requirements and regulations regarding the necessary production prerequisites.

The product specifications come from pharmaceuticals, cosmetics, medicine and automotive engineering fields, as well as the optoelectronics and foodstuffs sectors, and implementing them requires new ways of thinking, as well as new technologies and processes. Issues of how to protect a workplace against contamination by the environment, airborne particles and micro-contamination will gain more and more significance in the future of plastics processing. Meanwhile, sensitive processes in the aforementioned business sectors can only then be carried out with the desired safety and yield if micro-contamination of various kinds is successfully kept away from the process. Rarely, however, has a subordinate topic in an industry animated – or even alarmed – a business sector in the way that cleanroom engineering has within the plastics processing industry over the past few years. Today, production under special (controlled) ambient conditions is certainly gaining significance. Take the healthcare sector, for example. The average worldwide growth is between 7 and 9% per annum, except for Africa with roughly 3%. This market segment reflects all activities of the pharmaceutical industry and medical technology, including the application of plastics. Plastics are used, for example, for excipients and vessels, active and non-active implants or body fluid contact products, therapeutics, diagnostics and diagnosis aids, as well as lab equipment. The manufacturing of such products demands great responsibility both ethically and in terms of business. Compared to the manufacturing of industrial technical parts, there are extensive quality assurance measures, medicinally approved plastics, suitable machinery and accordingly higher qualified ambient conditions to be considered to comply with the extensive and strict requirements.

Higher measures More stringent acceptance specifications by the customer, as well as new legal guidelines and product liability, are forcing manufacturers to adopt even higher measures than previously when implementing processing units. This is why insulator technology, which is quite common in the pharmaceutical industry, has now become established in plastics processing. The purpose of insulator technology in pharmaceutical manufacturing is to guarantee product and personnel safety during the filling process of sterile products; that is, the processing and filling area is hermetically sealed off from the environment. Transferring this to plastics processing means that sealing the product off, hermetically, at the point of origin – perhaps even the assembly, as well as the packaging area – can make the frequently required sterilisation of sensitive plastic products redundant. Meanwhile, microstructure technology has become a central topic for the medical and pharmaceutical sector. According to a study, these sectors will be the fastest growing application areas of micro-technology in coming years. The focus is on disposable, microstructured test platforms for diagnostics for applications in haematology, microbiology, immunology and DNA analysis – for example, "lab on a chip". When manufacturing plastic products for the cosmetics and foodstuff industry, as well as for biotechnology, meeting the basic legal requirements, although always with an eye on cost considerations, will lead to production environments that prevent contamination to some degree. However, there will be increasing efforts to align component production and assembly, including packaging, under controlled ambient conditions – without the otherwise required intermediate steps such as cleaning and sterilisation – by introducing new plastics processing methods.

Production areas The production areas discussed have one thing in common – they are all affected by the requirement to eliminate contamination hazards by substances (particles, etc) or bacteria, as they are harmful to health. Production areas for microelectronics, precision engineering, information and communication technology, optics and, to some extent, the automotive industry, are in contrast influenced by the demand to achieve the highest possible yield, and thus economic production of functioning components, by guaranteeing appropriate ambient conditions in the processing area. In this case, the task of cleanroom facilities is to create the best environment for sensitive production processes. More and more products and manufacturing methods have been developed that need clean production environments. Increasing requirements in terms of reliability and cleanliness, as well as the further miniaturisation and complexity of components, have fuelled this need. The pre-eminent question discussed among processors in these sectors is: "Does it pay to install the costly facilities and put up with high operating and maintenance costs as well as additional costs for hygiene, cleanroom garments and personnel training?" Costly yes, but also potentially lucrative. After all, competition is fierce. Injection moulding can be carried out by almost anybody, but by applying such advanced technologies the processor stands out from the crowd. To be one of a few who has the know-how and the potential of being a reliable partner can be a tremendous opportunity in the future. A pharmaceutical company selects a manufacturer to make its products, so for this reason it is important that the contractor offers something special and is absolutely confident in its ability to manufacture such sensitive products. But first there must be investment – this is the primary obstacle to overcome.

Many benefits Processors which decide to get involved in this area, with all its consequences, can count on a long-term partnership with companies operating in the fields of pharmaceuticals and medical technology. Although rather conservative industries, they are the up-and-coming, lucrative markets of the future for plastics processors. The benefits of a clean production environment will not only pay off in technical and economic respects in the long run, but, due to the higher qualification, also secure the business a superior ranking in the market. Expert setup of a clean environment enables a processor to organise manufacturing processes with fewer production stages, less product transportation and reduced processing time. The clean, ambient zones can be reduced to a minimum in the construction phase, resulting in less investment and operating costs. Process safety and the reproducibility of product quality are without doubt affected by a clean production environment. The constant climatic conditions (temperature, pressure, humidity) eliminate any external disturbing influences on the process, so the rejection rate is not only minimised by limited particle contamination, but also by the constant ambient conditions. A processor which has consistently introduced this "sophisticated technology" to its production area and which respects and acts according to its "game and behaviour rules", will definitely have an advantage over competitors. The company will rank first when it comes to inquiries, product development tasks and the award of new projects with high quality requirements.

Premium image The acquired qualified environment and the sophisticated mode of operation provides the processor with a premium image, as under such a setup the output can only be of "best quality". Such a unique selling proposition is a door opener to lucrative business opportunities and ultimately leads to long-term customer loyalty. The planning of cleanroom production facilities should be carried out pragmatically. The exceptional investment should not be a reason for uncertainty because "not every cleanroom is alike"! All cleanroom operators are familiar with this platitude. What alarmingly few are aware of is that the costs may explode during the course of planning, construction and operation. The development cost should therefore be carefully calculated from the beginning. However, after looking at the complexity of a total cleanroom system and associated technology, it becomes apparent that it is virtually impossible to set up a precise and meaningful cost calculation or analysis and define the exact figure. Unfortunately, many potential operators believe that a cleanroom can be bought from the "rack". However, this is largely a false assumption. While there are application areas where – through project experience and consistent interdisciplinary co-operation with external r&d institutions – figures do exist, in general all conditions of product, process and environment must be taken into account. As when buying a car, there are no upper price limits, although many may think that premium quality technology can be purchased at a bargain price by negotiation. But know-how and technology have their price and all too frequently taking a step into the future is combined with an element of risk. If it was one's own capital or shares, then one might well be appalled by the voluntary risk taken. The business development unit of a company (the horror of every engineer) makes faster decisions on strategies than the market can often make. Unfortunately, this is carried out without having checked the financial implications. The investment costs of a cleanroom production facility may be comparatively low, but subsequently the system option, dependant on the process and product, is reflected in the operating costs. It has happened time and again that a cleanroom could not continue to be operated due to the tremendous running costs. As the size of a cleanroom increases, so investment costs per cubic metre decrease proportionately. This cost trend is true for cleanrooms of all classes, but the higher the class, the more apparent it becomes. In a chart, the curve for costs/constructed space (Fig. 1) would show extreme deviation behaviour.

Cost influences The two primary influences on overall cost development are the investment and operating costs.

Investment costs • Demands on the cleanroom in respect to classification, temperature, pressure, humidity, pollutants, facilities in the area of ionisation, etc • Requirements in the implementation phase in terms of concepts for complete or partial areas, mini environments or insulator solutions • Operating mode, as well as redundancies • Specifications of monitoring systems for controlling/recording and respective software and measuring systems • Overall construction of building as well as environment protection measures.

Running costs The running costs immediately reveal if the cleanroom has been planned and implemented in the best and most functional way. At this point it becomes clear if the operating costs correspond to the actual running costs. The four big blocks of operating costs are divided into: • Energy costs – heating, cooling, ventilation • Running costs – chemistry, etc • Running costs – maintenance, garments, cleaning, cleanroom qualification, etc • Materials

Communication required It is difficult to define and document costs and implement them in a project, but it is possible if planners and users collaborate in an open, constructive and co-operative way. Unfortunately, it is quite often the case that there is no helpful, and necessary, "communication" – for whatever reasons, be it due to vanity, arrogance or exaggerated fear of the unknown. A cost schedule can usually be controlled reasonably well by detailed planning. Project necessity and lack of know-how often lead to mistakes, which if ignored, will accumulate to a multiple of the original costs (Fig. 2). Of course, not all projects can be grouped together, because size and specifications are normally different. But the error rate – generated by the wrong ambitions and ignorance, as well as incorrect cost awareness – head the operator directly into an area where the costs can explode. To make things easier, the general trend of the running costs can be shown in a simple scheme. On average it can be presumed that after three or four years the running costs will have reached the amount of the investment costs. After a period of about 14 years the running costs will have reached the double amount of the investment costs. These time periods constitute an average value derived from the experiences of many businesses and users. The better the facility has been planned, the longer the time intervals (Fig. 3). It is also important that there is a permanence and stability in the area of energy costs. Another cost factor not to be neglected is the process itself. Taking the example of injection moulding for applications in the healthcare sector, it is clear that the direct requirements for carrying this out under cleanroom conditions is not an area that has not been considered by most injection moulders. Here, the motto is clearly "not every injection moulding is alike". International standards and guidelines such as cGMP and FDA regulations call for a standard that clearly separates the wheat from the chaff in theory and practice, with respect to process facility suppliers and manufacturers of machines and peripheral devices. Constant, ongoing developments in application engineering are absolute prerequisites in this new technology sector to be able to survive in the market. With consistently rising production requirements, the costs for machines in terms of their integration feasibility increase (Fig. 4). Even injection moulding applications under ambient conditions Class A, according to cGMP, or Class 5, according to DIN EN ISO 14644, is becoming increasingly necessary. There are two associated kinds of applications; depending on the requirement they split into a "low cost" and "high cost" range. The low cost version includes application solutions that do not run as a permanent process. In this case, a partial purity or cleanliness is achieved that cannot guarantee continued process safety, according to cGMP and FDA criteria. If proceeding to more demanding production requirements and processes, there is a continuous increase in production equipment costs. The machines and the additionally assigned process-related sub-functions are, of course, also affected. Manufacturers of comprehensive and complex process technologies are additionally confronted with a seemingly insurmountable mountain of requirements concerning qualified systems. The ultimate discipline, namely to integrate a complete process in the cleanroom and operate it, represents technically the most difficult and expensive application engineering alternative.

No avoiding the future In product engineering today and in the future, it will not be possible to avoid applying cleanroom integration developments if one is to meet the high specification requirements of the product and operate processes which can be validated, even if in their application they increasingly move away from the cost-base norm associated with manufacturing. Combine all of this with the ultimate perception of precision, of the requirements of the facilities, processes and products, and it can be seen that there is no absolute certainty in the application process, just as there is no absolute cleanliness and sterility of the product or the process site. Ultimately, it is the openness of all project and process participants that makes it possible to "just think a little bit around the corner".