Sanitization frequency

Where firms have introduced unidirectional air systems in preparations and compounding areas for particle control, there is often the temptation to expect these areas to meet the same microbial limits that these locations might attain in the aseptic core. This temptation should be resisted to avoid unnecessary sampling and deviations associated with expecting these environs to meet the conditions of aseptic areas where sanitization frequency, background environment, and most importantly personnel gowning are far superior to that found in the less clean locales [33]. 

Storage tank and in the circulation loop at ambient temperature most of the time (this requires an extra heat exchanger with cooling water on the shell side). To achieve microbial control, such system (or any system that includes ambient loop) needs to be periodically sanitized by heating up its contents to about 80° C and holding the temperature for at least 1 hr. The sanitization frequency can vary from once a day to once a week or less the lower the frequency is, the more attention to the studies proving the effectiveness of the microbial control shall be expected. 

Calcium Hypochlorite. This chemical, marketed since 1928, is one of the most widely used swimming-pool water sanitizers. Calcium hypochlorite, a crystalline sofld, is a convenient source of available chlorine and is sold in granular or tablet form for use in home, semiprivate, and commercial pools. When dissolved in water, Ca(OCl)2 forms hypochlorous acid and hypochlorite ion similar to NaOCl. It contains small amounts of stabilizing Ca(OH)2, which has a very small effect on pool pH (7). Calcium hypochlorite has superior storage stabiUty and much higher available CI2 concentration than Hquid bleach, which reduces storage requirements and purchasing frequency. 

The frequency of sanitization derived from the trend analysis of the microbiological data should be used as the alert mechanism for maintenance. The frequency of sanitization should be established such that the system operates in a state of microbiological control and does not exceed alert levels. 

Utilities Qualification a) Extension of water treatment capacity b) Add an additional loop c) Change of supplier for filter, resin, activated carbon, RO membrane, etc. d) Sanitization procedure or frequency change IQ, OQ, PQ QA + Concerned dept, managers QA + Concerned dept. Managers QA + Concerned dept, managers QA + Concerned dept, managers... 

Facility Qualification a) Any alteration in area specification b) Sanitization procedure or frequency change Area Qualification QA + Concerned dept, managers... 

In addition to cleaning all accessible work zone surfaces, the Class II BSC worksurface tray should be lifted up and back, and the area under the tray should be thoroughly cleaned with the same frequency as the other user-accessible worksurfaces this is of particular importance in preventing the buildup of potentially harmful product residues. All materials used in cleaning and sanitizing should be treated as toxic waste, and disposed of in accordance with state and local... 

It is important to point out that a small number of microorganisms surviving in the purified water system do not necessarily affect the water quality. Because of the lack of nutrients and other unfavorable conditions, the microbial growth in such waters is very slow. That provides operators with an option to maintain such systems in the state of microbial control by sanitizing them periodically rather than continuously, as long as the frequency is high enough to keep the bacterial counts at acceptable low levels. ... 

A comprehensive Facility Cleaning and Sanitization Program with an initial schedule for each room will be developed, with procedures based on the initial sanitization validation results, the criticality of operation performed in each area, and the frequency of use. The initial schedule will be modified as necessary based on routine environmental monitoring. The environmental monitoring results will be compared against alert and action levels. 

Stationary equipment such as conveyors and filling equipment must be sanitized at some specified frequency. This can be accomplished by wiping down with a sanitizing agent or fogging the sterile area with formaldehyde. All product contact parts such as powder hoppers, filling wheels, and stopper bowls are removed from the sterile area, cleaned and sterilized as previously described. 

Preuse validation of deionizing systems used to produce purified water should include consideration of such factors as microbial quality of feed water (and residual chlorine levels of feed water where applicable), surface area of ion-exchange resin beds, temperature range of water during processing, operational range of flow rates, recirculation systems to minimize intermittent use and low flow, frequency of use, quality of regenerant chemicals, and frequency and method of sanitization. 

Two F-15s were tasked that day to be the first aircraft in the TAOR and to sanitize it (check for hostile aircraft) before other coalition aircraft entered the area. The F-15s reached their final checkpoint before entering the TAOR approximately an hour after the helicopters had entered. They turned on all combat systems, switched their IFF Mode I code from 42 to 52, and switched to the TAOR radio frequency. They reported their entry into the TAOR to the AWACS. 

As mentioned above, it is common to clean food processing equipment with sanitizing solutions. For example, in fats and oils processing equipment, there is a need to clean out the equipment with caustic in order to remove organics. Steam cleaning is a common requirement. Almost all equipment is sanitized at some frequency and this often involves chloride environments [4,7]. Clean-in-place S5 tems are usually used. 

This documentation allows the winery to accurately describe what procedures, frequency, and chemicals were used to ensure that operations were conducted in a consistent manner. At the conclusion, representative surfaces should be sampled for microbiological populations and/or excess sanitizer. All data should be collected for future examination and potential changes. These records not only become part of the overall quality points program (Chapter 10) but also will serve as documentation if a legal issue arises. 

---