Installation clean agent systems

Floors Commonly used floor finishes for biopharmaceutical clean rooms include sheet vinyl installed using heat-welded or chemically fused seams to provide a seamless surface. Troweled epoxy and epoxy paint (Figure 11) have also found wide use. Compatibility of the floor material with solvents, chemicals, and cleaning agents to be used in the room must be considered. A minimum 4-in. cove at the junction of floor and walls is recommended to facilitate cleaning. Some modular wall systems have a recess or offset that permits sheet vinyl to be installed in a manner that creates a seamless junction between floor and wall. When a stick-built approach is used, care should be taken to design cleanable intersections of walls and floors (Figure 12). 

Water is one of the key utilities in most pharmaceutical facilities. It is used as a solvent, product ingredient, cleaning agent, and for many other applications. Some of those applications require water of higher purity than typically found in municipal water supplies. Therefore companies install private water purification systems that become a critical part of their utility infrastructure. 

Materials used must cleaned and disinfected with the usual cleaning and disinfecting agents. Friction in the transport system must not cause particles. Electric motors without ventilators must be used and the sensors installed must be resistant to the cleaning and disinfecting agents. In general, every process must be reproducible, documented and validated. 

The product contact surfaces in this environment are typically removed for cleaning however, in some installations, the sterilization, transfer, and reinstallation of the component feed hoppers present such difficulty that these systems are decontaminated in situ with a sporicidal agent, rather than removed after each use. These units should still be removed for cleaning and sterilization on a validated periodic basis to prevent the buildup of residues that might impact their in-situ decontamination or create particle control problems. All other product contact surfaces should be sterilized prior to each use. Nonsterilized items should not be allowed to enter the ISO 5 portion of the fill zone, and sanitization is essential for all nonproduct surfaces in the fill zone, as well as the surrounding background environment. 

These interim cleaners also support the philosophy of just-in-time cleaning. Chlorinated solvents and alcohols find perhaps their widest application as quick-dip-rinse media. When water-soluble coolants are installed, and solvent tanks become obsolete, they must be replaced by a waterbased rinse system. Total reliance cannot, and should not, be placed on the final cleaning system in view of the fact that specialized solvents cannot be used anymore. Water, while an excellent departiculating agent, is not as effective in removing nonpolar contaminants from surfaces. With chemical contamination emerg-... 

In addition to the adoption of a Low Emission Vehicle/Clean Fuel program, the California Air Resources Board (CARB) has adopted regulations which call for comprehensive on-board monitoring of seven components and/or events related to emissions of exhaust, fuel, and air conditioning heat-transfer agents for vehicles sold in California. This legislation is called "On-Board Diagnostics-Phase II" or "OBD-II" [30]. These systems were installed on all vehicles sold in California in the 1996 model year. The Environmental... 

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