Greater collaboration provides new integrated solutions
by Hans-Christian Gath, Director-Business Development, M+W Zander Products
The requirements and scope of contamination-control solutions have changed significantly over time. In the early years, when contamination-control technology largely focused on the needs of the semiconductor industry, large cleanrooms were the norm. But, in the course of technological development, and the emergence of other demanding applications, it has proven advantageous for different industries to introduce a range of cleanroom sizes and conditions based on the specific requirements of their unique process steps.
Figure 1. A 200-mm semiconductor production line with integrated minienvironments. Courtesy of M+W Zander Products.
Clearly, not every process step requires the highest cleanroom classification, and particularly critical areas can be isolated to improve individual process conditions. These isolators or minienvironments can be integrated within the large cleanroom, rather like a cleanroom within a cleanroom (see Figure 1). Although this entails changing existing production lines and adapting the facility’s equipment and architecture, the principal benefit offered to customers is an overall reduction in requirements at the periphery of the process equipment, making it possible to significantly reduce operating and investment costs.
Ultimately, to efficiently provide complete and integrated contamination-control solutions for production and process technology, it’s necessary for contamination-control professionals and companies to work closely with the manufacturers of process equipment, and filling and packaging machinery.
New applications, requirements
It is the cost savings achieved through the introduction of smaller cleanroom solutions that in fact laid the foundation for transferring this innovative technology to other industries, such as pharmaceuticals and biotechnology, where tiny airborne particles may themselves be pathogens or carry contaminating substances.
The fundamental requirements for cleanliness and sterility are significantly different, however, in life-science manufacturing environments than for microelectronics. For example, in the semiconductor industry, the aim is to create the necessary “clean” ambient conditions required for the maximum production output of functional microelectronic elements. In contrast, biologicals and pharmaceuticals primarily demand completely sterile or contamination-free working conditions to prevent any possible risk to human health.
As a result, additional factors such as national and international regulatory guidelines and procedures have a major impact on the established conditions for systems, cleanrooms and process equipment used in laboratories and production facilities. For example, Good Manufacturing Practices (GMPs) are geared toward recording and checking all functions relevant to quality alongside the manufacturing processes that are relevant to ensuring appropriate product quality.
Even within the life sciences alone, individual product types require different and specialized forms of production and environmental controls. For example, the manufacturing and packaging of solid medications, such as pills and coated tablets, have different requirements from those of liquid drugs. In the case of even more specialized products, such as effervescent tablets, the control of relative humidity becomes a critical environmental factor.
Figure 2. An isolator for the production of active pharmaceutical ingredients. Courtesy of M+W Zander Products.
Vaccines and hormones also demand additional special measures for safeguarding personnel and the environment. Very often, only small cleanrooms or isolators are required for these individual process stages (see Figure 2), but these can ensure separation of personnel from product, achieving a level of security not attainable with conventional cleanroom technology. Additional cost savings can also be achieved since cleanroom cabins and isolators are prequalified at the factory in conformance with GMP guidelines, and won’t require additional on-site qualification.
Figure 3. A prequalified Biotech Clean Chamber for sterile processing. Courtesy of M+W Zander Products.
Filling and packaging operations are also benefiting from the targeted use of contamination-control spaces. Whereas older-generation filling machines were set up to operate in large cleanrooms or housed in cleanroom cabins, today packaging-machinery manufacturers are protecting product from contamination with laminar flow units integrated with and configured directly above the filling area. Flow-optimized minienvironments with selective ultraclean airflow, pressure maintenance and exhaust, or the integration of isolators for hermetic sealing of the filling area from the environment (see Figure 3) keep product, people and the environment absolutely clean.
Figure 4. A sterile filling machine with laminar flow unit. Courtesy of M+W Zander Products.
Apart from drug production, other life-science applications, such as stem-cell research and bioengineering, are also subject to strict GMP regulations. This industry is largely composed of small, highly innovative companies that demand small and flexible cleanroom solutions with low operating costs and small upfront investment. Here, individually configurable, modular cleanroom cabins and isolators have proven successful with the trend toward fully equipped mini-laboratories with high-level cleanroom classifications (see Figure 4).
Tissue engineering is another uniquely demanding life-science application. New types of tissue substrate and innovative culture techniques offer the best prerequisites for developing complex tissue and organ structures, and this must be accomplished in ultraclean conditions. As it is increasingly difficult for individual organizations to (pre)finance the massive cost of developing the contamination-control environments and systems needed for this work, individual research companies and hospitals are frequently collaborating with cleanroom system and contamination-control technology manufacturers to develop solutions. Together, the aim is to accelerate the transfer of product from the research laboratory, through manufacturing samples for clinical trials in hospitals, to full-scale production.
Another benefit of joint development is reduced risk of failure. The added value that this provides to the operators of contamination-controlled and clean process and production equipment is based on the premise that process equipment manufacturers provide operators with a system solution originating from a single source, linked with a guarantee of reliability or productivity. The key benefits of cleanroom solutions integrated within process technology are the guarantee of maximum cleanliness and process control directly at the product level. This ensures higher productivity, significantly reduced investment and operating costs, and also accelerates “time-to-market” from research to full-scale production. III
Hans-Christian Gath is the director of business development for M+W Zander Products. He can be reached at firstname.lastname@example.org.