Advanced Barrier/Isolation Technology Saves Cost/Space
Implementing advanced barrier/isolation technology requires a careful analysis of a company`s process and facility requirements. Its benefits are reduced capital costs and operating expenses.
By Henry D. Rahe
A competitive world creates new and better ways to achieve our goals. In many cases, this involves development of new technologies that allow us to work more efficiently. Barrier/isolation technology is not a new technology: it developed over 50 years ago. However, recent economic pressures are causing many industries to embrace the basics of this technology and adapt it for a variety of applications. I have chosen the term “barrier/isolation technology” to describe a device or means for creating an independent environment. Within this independent environment, activities can take place without being affected by the environment in which the device is located.
Currently, there are a number of groups working to create definitions, terms, and guidelines to describe barrier/isolators. Some will spend a great deal of time creating definitions that differentiate the two terms, but in the end, barrier/isolators are comprised of four basic components. They are:
The shell that defines the boundaries of the barrier/isolator system
The air handling system that creates the internal environment
The personnel and product interaction systems
The monitoring systems that confirm the integrity of the system.
Each of these components is built with a variety of construction materials and techniques. The development of general guidelines for these major system components to assure quality systems will greatly benefit both manufacturers and end-users. However, if the guidelines extend beyond specific industry boundaries, this will be a very difficult task. Individual industries have very different requirements in terms of environmental conditions and regulatory expectations.
The ability to adapt barrier/isolation systems to specific industry needs requires an understanding of the activity or unit operation taking place within the barrier/isolator. It is also important to understand the relationship of the given operation to the overall process and the regulations governing these operations.
Barrier/isolation technology is changing the entire approach to applications from electronic component and microchip manufacturing (where clean conditions are the bottom line in terms of manufacturability), to medical devices, pharmaceuticals, hospital pharmacy, and home health care to food processing facilities. Even the very reason for existence of these facilities–the unit operations which constitute the manufacturing process–takes on a different form. Each operation becomes a self-contained station capable of being linked together with other units to form an entire production process independent of the building shell.
Meeting Quality Standards
The use of modular-style construction in internal walls and ceilings, combined with the barrier/isolation approach, offer a mobile manfacturing platform for establishing new facilities in developing countries, designed not just for local markets but for export. To meet the quality standards of the targeted export markets–Japan, the European Common Market, and the United States–facilities must be constructed to a standard consistent with the regulatory requirements of the importing country. In the case of medical device and pharmaceutical facilities, this means following current good manufacturing practices (cGMPs) as interpreted by the FDA.
With medical device and pharmaceutical facilities, meeting the requirements and expectations of regulatory groups such as the FDA (United States) and the MCA (United Kingdom) means using proper construction materials and techniques for assembling those materials. The construction skills and techniques required to deliver a manufacturing facility that will meet cGMP requirements are not as well understood and are sometimes unavailable in many countries, where lack of experience or the unavailability of resources can extend project completion time, and in many cases, cause significant cost overruns.
Creating Mobile Manufacturing Capabilities
The barrier/isolation approach creates the primary manufacturing environment as an integral part of the process equipment, including stand-alone air handling, conditioning, and filtration systems specific to the needs of the process. Only the basic support utilities need to be supplied. The barrier/isolator also provides the proper interior surfaces, environmental conditions, defined interactions, and monitoring systems which can be pre-tested and verified before shipping. The ability to validate systems in locations where complete technical support is available allows for quicker installation and initial startup, using less of on-site resources. With the benefit of knowledge gained from the initial effort, on-site validation becomes a re-validation.
The use of modular wall, ceiling, and mechanical packages creates the proper balance within the interior of the facility; the basic building shell is needed only as protection from the elements. The modular construction technique reduces actual construction time and provides a predetermined quality of interior surface and architectural expectations. Modular facilities can be put in place by just a few skilled individuals with the assistance of a local work force.
The implementation of barrier/ isolation technology applications, however, requires careful analysis of your facility. Says Scott Mackler, general sales and marketing manager for Clestra Cleanroom, Inc. (North Syracuse, NY), “The key elements in the thoughtful integration of barrier isolation technology into today`s pharmaceutical and biotechnology facilities are a careful analysis of process and facility requirements and the implementation of a diagnostic approach. The integration of modern barrier technology into cGMP facilities can yield measurable benefits.”
Implementing Barrier/ Isolation Technology
Applications of barrier/isolation technology encompass all phases of business activities, including research, development, manufacturing, and packaging. Incoming inspection through product fabrication and packaging operations(which require either product or personnel protection) offer potential for barrier/isolation technology.
In the pharmaceutical industry, barrier/isolation systems have been used for incoming inspection and sampling, weighing, compounding, compression, coating, aseptic filling, and product packaging. Each individual operation needs to be evaluated in terms of function and economic viability. Here are some tips for organizing a potential application:
Understand the complete function of the activity
Build-in such support needs as maintenance and sampling
Define the area of activity–“Think Small”
Write a “requirements” document defining function and interactions
Get internal consensus before involving vendors.
These tips may seem simple, but in many cases, they are difficult to achieve internally. A qualified outside resource may be just what is needed to help organize and add credibility to the process. This type of resource is also helpful in formulating a plan of implementation for your company to follow.
A typical plan should contain the following elements:
A qualified vendor list
Other end-users who have completed similar projects
Internal “requirements” documents to serve as a vendor communications guide
Interviews with multiple vendors
In-process checks (such as conceptual drawings and mock-ups)
Involvement of everyone from beginning to end.
Because the best planned and implemented projects come with a number of issues that must be resolved in a timely and effective manner, it is important to identify a focus person or project leader who will be responsible for communication and overall project activities.
The major driver in the implementation of barrier/isolation technology is cost effectiveness. The two major areas of savings are (1) reduced capital cost (in terms of facility construction or renovation) and (2) operating expense. While most everyone agrees on the savings achieved by reducing operating cost, there is no clear consensus as to capital cost savings, with opinions varying from slightly more expensive to as much as 40 percent less expensive.
Savings should be determined on a project-by-project basis, so that each company can choose the most cost effective way to achieve their particular objectives. For a listing of cost factors to be considered in the evaluation, see “Capital Cost Factors.”
In summary, advanced barrier/ isolation technology can offer a mobile manufacturing platform, from which processes can be performed in virtually any location while meeting cGMPs. As a technology, it provides flexibility and cost savings on both the capital and operating sides. n
Henry D. Rahe is the director of technology at Contain-Tech (Indianapolis, IN). He has nearly 30 years of technological experience, including project management, and publicizing and presenting seminars. In 1993, Rahe was the “Environmental Management” course leader at the International Society of Pharmaceutical Engineers annual meeting. At CleanRooms East `94, he presented “Microenvironments in the Pharmaceutical Industry.” He is on the board of directors of the International Society of Pharmaceutical Engineers, a senior member of the Institute of Environmental Sciences, and a member of the CleanRooms Editorial Advisory Board.
Capital Cost Factors
Total cost of space required for operations and support activities
Differential cost for higher quality space required in non-conventional facility
Differential cost of mechanical and utility support equipment
Cost of reconfiguration or relocation
Cost of engineering and validation (may be capitalized)
Cost of money involved with longer project time.
Operating Saving Factors
Protective clothing and disposables
Maintenance and replacement of filters and other disposable environmental components
Potential operating efficiency gained by better control and access to the operating environment
Labor efficiency gained by elimination of operator time required to change into protective clothing.