Barrier Isolation - The “Must Have” Technology for 2014
On November 15, 2013 USA Today reported that consumers had waited up to eighteen hours in line to purchase the new Playstation 4. A week later, the Associated Press announced that the release of the new Xbox One hit sales of over one million worldwide on the first day of release. This is an illustration that keeping up with the latest and greatest technology is, in part, one of personal preference, but the timing also suggests that this is an indicator of business necessity. In this particular case, Sony and Microsoft are driven to deliver new and updated gaming products to maintain their portion of the market share. This phenomenon is certainly not isolated to gaming or electronics, but rather extends to all facets of advanced industry, including healthcare and health science. Developments in medicine and treatment continually affect manufacturing technologies, methods, and applications.
Barrier isolator technology is one such area of pharmaceutical manufacturing where the latest and greatest technology is becoming a driver of business necessity. Pharma companies in the United States are starting to respond to issues of aseptic manufacturing more prominently through the use of barrier isolator applications, but the question remains why this proven method that has been in existence for over twenty-five years has not completely replaced traditional clean room practice?
A Slow but Steady Tradeoff
Isolators were first introduced into the pharma industry in the 1990’s and were widely considered acceptable for aseptic manufacturing across Europe. However, implementation in the United States was not as prominent, as companies were reluctant to deviate from approved traditional clean room facility and manufacturing techniques. Considerable amounts of capital went into the construction and validation of clean room facilities so the issue of cost, ultimately driven by return on investment, justified working within the status quo. Eventually, the LUMS Group (Lilly, Upjohn and Merck) gave isolator technology a chance in the United States thus clearing the path for others to follow, but most aseptic projects still start out with a cost benefit analysis of isolator technology versus traditional clean room techniques. For new construction and existing renovation, isolator technologies are starting to increase in the marketplace for aseptic manufacturing. This is partially due to the potential for smaller building footprints through elimination of transitional spaces, gowning areas, and long narrow room geometries driven by unidirectional airflow patterns required in traditional clean rooms. Moreover, what once was a decision based on construction costs and the logistics of implementation now has a tertiary set of variables that collectively make isolator technology an attractive approach for pharmaceutical companies in the United States.
A Change in Priorities?
Pharma companies can no longer maintain viability in the marketplace by primarily considering the accounting ‘bottom line.’ In the United States, a cultural shift in business towards quality over quantity has reprioritized issues related to safety, staffing, energy use, and life cycle costs. As such, consideration of social and environmental factors, in addition to economic realities, is relevant to public perception and increasingly necessary to legitimize business operations. This is uniquely paramount to the pharmaceutical industry where patents on name brand drugs expire and company branding and market identity become crucial to the continued success of product distribution.
Risk mitigation has become a top priority for all manufacturing facilities with respect to regulatory compliance, environmental monitoring, product contamination, and overall product quality. Such risks are fairly easy to identify and validate; however, no advancement in technology can ever account for human error or intervention. Are operators utilizing the proper protocol for gowning and minimizing particulate generation rate? In this regard, isolator technology is perhaps the greatest risk management tool available to the pharmaceutical industry as it effectively removes personnel from the product manufacturing environment.
In addition to providing a higher level of safety, isolator technology adds efficiency to the entire manufacturing process. First, barrier isolators utilize Vaporized Hydrogen Peroxide (VHP) cycles for decontamination. Initial cycles could last up to twenty hours; but with the reduced aeration time via a catalytic converter loop, cycles can now be completed in approximately two hours. Also, barrier isolators offer the best contamination mitigation currently available, thereby minimizing the risk of losing an entire batch of product. In addition to acting as a barrier for possible contaminants, isolators act as the container for hazardous materials and potent compounds by switching the pressurization to negative. This extra level of defense allows for a more efficient layout when installing more than one manufacturing line. Finally, isolator technology allows companies to transition valuable manpower from the detailing of a traditional clean room allowing that time to be spent focused on manufacturing details instead.
Life cycle costs dealing with maintenance, energy use, and sustainable life also have begun to sway in favor of isolator technology. The most advantageous aspect of maintenance deals with the significant amount of savings from running class 10,000 space at rest versus class 100. In this scenario, minimizing airflow can quickly recoup initial costs when combined with savings in gowning material and operator prep time entering the space. This also ties into less energy usage primarily around the overall amount of volume required to have unidirectional airflow. Also, isolator technology is flexible in its use and product manufacturing capability. While traditional clean rooms may require comprehensive renovation to accommodate new product lines or to meet more stringent regulatory standards, isolator technology is suitable for a wide variety of applications that meet the most restrictive process guidelines.
A Brave New World
Isolator technology offers a new and innovative physical environment as a viable response to all the current issues facing the pharmaceutical manufacturing industry. A smaller building footprint not dictated by clean room geometries provides cost savings and added flexibility in planning, both at the building and at the larger scale of the site. Increasing FDA regulations suggest that clean rooms will become increasingly difficult to validate and operate in the future. Life cycle costs also favor the implementation of isolator technology over traditional practice. In addition, there is the potential to increase staffing efficiencies and satisfaction in the work place as less gowning equates to greater comfort to operators.
Within the industry there are a number of isolator technology vendors serving clients in all parts of the world. It is becoming standard practice for the vendors who do not manufacture their own filling lines to work seamlessly with other parties during the design phase. This often results in an option for combined Factory Acceptance Tests (FATs) which results in higher personnel utilization and additional confidence in the product line equipment.
All methods of drug manufacturing are expensive. In some cases, isolator technology may be more cost efficient than a traditional clean room and in projects of a smaller scale, implementation may not be financially viable; however pharmaceutical companies are in the business of manufacturing product, not building clean rooms. Utilizing the latest and greatest technology in aseptic manufacturing will assure that pharmaceutical companies can remain competitive and viable in the marketplace. With the host of multiple factors that now need to be considered in the selection of a manufacturing process, isolator technology is poised to continue its growth in the United States and become the dominant application for aseptic manufacturing in the future.
About the Author
James Hirt, RA of Kezlo Group, LLC has more than fifteen years of experience in architectural design and project management in the pharmaceutical industry. His last five years have been focused on managing projects utilizing barrier isolator technology in aseptic manufacturing worldwide. www.kezlo.com