Addressing Hazardous Location applications in the Pharmaceutical industry with Purge and Pressurization.

Tyler Redslob Business Development Manager Bebco EPS, CorrTran, Field Devices Pepperl+Fuchs, Inc. Twinsburg, OH 44087 KEYWORDS
Hazardous Location, Purge and Pressurization, Intrinsic Safety

ABSTRACT
There are three methods of addressing hazardous location applications in the pharmaceutical industry. The three methods are: containment, prevention, and segregation. Containment is accomplished through explosion proof enclosures. Prevention is accomplished through the use of intrinsic safety barriers. Finally, purge/pressurization addresses the segregation method. The presentation provides an overview of the three methods and addresses the standards to which purging and pressurization systems must adhere. Applications where purge/pressurization have been used in pharmaceutical processes are discussed, and why the segregation method was selected.

Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org

INTRODUCTION
The three methods of addressing hazardous location applications are containment, prevention, and segregation. These methodologies are used in nearly every industry throughout the world. The principle behind these methods is to eliminate at least one of the three corners of the ignition triangle. The three corners of the triangle are the ignition source, oxygen, and the fuel. (Please see Figure 1.) Each offers advantages and disadvantages to the user. In some applications, combinations of these methods may be used, in other words, they are not mutually exclusive. The purpose of this paper is to review the three methodologies and how they are accomplished in order to meet defined standards. Additionally, applications will be described as to where they are used, why they are used and how they were used.

Ignition Source

Oxygen Figure 1 Ignition Triangle

Fuel

First Method: Containment

One method of addressing hazardous location applications is containment. The explosion proof or flame-proof method is the most widely used in the North American market. In this method, an explosion is permitted to occur, but must be contained within the enclosure. By containing the explosion, the flames are essentially cooled, and not permitted to exit the housing in to the surrounding area. This eliminates the possibility of the flame to ignite any explosive gasses outside the enclosure. Typically, the enclosure is made of aluminum. These types of enclosures can be used for higher power applications. A major disadvantage of this method is that the enclosures are very heavy and very costly. The seals and conduit also must be carefully installed. If these are not installed and maintained properly, it can result in a dangerous situation. The enclosures are screwed closed or secured with multiple bolts places around the entire perimeter of the housing. When the cover of the enclosure is removed, care must be taken to not scratch it. Any deformation of the cover may result in enough of an opening for a flame to escape. Heat and condensation build up within the housing are also disadvantages to this method. Electrical equipment does not last as long when exposed to excessive heat or condensation. Performing live electrical work within the panel is also not possible. This method is not suited for all hazardous location applications. Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org

Second Method: Prevention

A second method of addressing hazardous location applications is prevention. Very widely used in the European marketplace and increasing in usage in North America, this technique limits the voltage and current to low levels. There are two methods of protecting instrumentation by intrinsic safety. One method is to use zener diode barriers and the other method is an isolated intrinsic safety barrier. Both types use an energy-limiting network. The difference between these two methods of protection is that the isolated intrinsic safety barrier does not require an intrinsic safety ground. Zener barriers require a high integrity ground to be installed. In each case, any stored energy is limited to a level that will not allow an ignition to occur. This technique does not require any special cables and is safe for personnel. Hot permits are not required, and intrinsic safety can be used in every type of hazardous location area. Since the principle of this technique is to limit the voltage and current, high power applications will require another of the two protection methods.

Third Method: Segregation

The third method for addressing hazardous location applications is segregation. The purge and pressurization technique employs the use of clean or inert gas to address the hazardous location. The clean or inert gas is used to keep the enclosure at a higher pressure than the pressure outside the control cabinet. By keeping the enclosure at a higher pressure, electrical equipment can be operated inside. The equipment is kept off during the initial start up and if pressure is lost, power to the enclosure equipment is disengaged. NFPA 496 defines the Standard for Purged and Pressurized Enclosures for Electrical Equipment. Purge and pressurization may be the only practical option in a hazardous location if higher power equipment is needed. Since clean or inert gas is needed, sometimes the application will not have the gas in close proximity to the control cabinet, and this can limit purge and pressurization usage. Another limitation of purge and pressurization is that maintenance cannot be performed on the equipment, unless the manufacturer provides a bypass switch. There are three different types of purge and pressurization systems, X, Y, and Z. Types of Purge and Pressurization Systems There are three types of purge and pressurization systems. Each type indicates what type of equipment can be placed inside the electrical enclosure. Type X systems reduce the area classification within the enclosure from Division 1 to non-hazardous rated or general purpose. Type Y systems reduce the area classification within the enclosure from Division 1 to Division 2. Finally, Type Z purge and pressurization reduces the area classification within the control cabinet from Division 2 to general purpose. In type Y and Z purge and pressurization applications, removal of power to the enclosure is not required on the loss of pressure. Upon the loss of pressure in a Y or Z purge, there must be an audible or visible alarm. For X type purge system there must be a timer. The timer is to prevent the start up of the electrical equipment within the control cabinet. Four complete volume changes of the entire control enclosure must occur before power is energized. In Europe, five volume changes are required.

Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org

Applications of Purge and Pressurization Systems within the Pharmaceutical Industry

With an overview of the three methodologies discussed, three applications in the pharmaceutical industry are illustrated.

Application #1
A large pharmaceutical corporation was upgrading their control systems from PLCs to PC based controls. The PC had to be located in the hazardous location. They turned to a manufacturer who packaged the PC into a workstation that was purged. The PC is actually located in the Class 1 Division 1 area. The materials used to make a PC are rated for general purpose therefore they incorporated an X type purge. Without purge and pressurization this previously would not have been possible as the explosion proof box would not have given the company the ability to go to PC based control as they would not have been able to easily access the PC inside the box.

Application #2
A centrifuge manufacturer for the pharmaceutical industry had to have general-purpose equipment inside the enclosure. The material in the centrifuge was to be separated. The composition of the material was solid and liquid, and the liquid had to be separated from the solid, so the solid could then be further refined in the pharmaceutical process. The area involved was a Class I Division 2. As a result they needed to use a Z purge as it allowed them to use general-purpose equipment inside the enclosure once it was purged and pressurized. External temperature sensors were also used in this application. These sensors were connected to a intrinsically safety barriers inside the enclosure. In this application, two of the three methods were used to address the hazardous location.

Application #3
A new reactor needed to be installed in a pharmaceutical plant. The reactor is lined with glass and contains an agitator to help with the mixing of the drug. A variable frequency drive (VFD) was engineered in to the process in order to control the agitator. The VFD was placed in a NEMA 4X enclosure along with other general purpose rated equipment. The reactor also requires heating and cooling throughout the process, so temperature controls were also inside the enclosure. The enclosure was purged and pressurized and allowed them to upgrade their controls and incorporate more state of the art equipment in the manufacturing of the drug.

Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org

Conclusion
The pharmaceutical industry is an industry that has incorporated purge and pressurization as the method for addressing hazardous locations. Some view the pharmaceutical industry in two segments, chemically derived and biotechnology derived. There are more applications for purge and pressurization in the chemically derived processes. This is primarily due to the fact that the chemically derived processes often involve acetone, alcohol, methanol and other potentially ignitable solvents. It is important to note that these applications do not have to be in liquid form to be hazardous. The applications involved and discussed also involved powder forms of drugs. Three application examples were provided after discussing the three methods of addressing hazardous locations, containment, prevention and segregation. Many applications have been addressed in the pharmaceutical industry using purge and pressurization solutions. Companies that provide chromatography, heat transfer systems, thermal oxidizers, and reclamation as well as the other applications mentioned have benefited from incorporating purge and pressurization. If the pharmaceutical process is a chemically derived process, and has solvents such as acetone, methanol or alcohol involved, purge and pressurization is a viable hazardous location protection method.

Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org

REFERENCES
NFPA 496, Standard for Purged and Pressurized Enclosures for Electrical Equipment, 2003 Edition. Guide to Intrinsic Safety, Elcon Instruments Engineering Department SATE Zingonia (BG) 1996, p. 1-3.

Copyright 2004 by ISA The Instrumentation, Systems and Automation Society, Presented at ISA Automation West 2004; http:/www.isa.org