SANITATION MONITORING

Once the sanitation cycle has been completed, all surfaces must be thoroughly rinsed to flush residual sanitizer and solubilized debris. Tank/hose sanitation is typically followed with citric acid rinse to neutralize residual alkali. The final rinse water should be tested for residual oxidants (Zoeck-lein et al., 1995). This may be done in the laboratory or cellar by use of kits designed for this purpose. 

The cleaning process, by itself, will significantly lower microbial populations, but, depending on the degree of debris buildup and the effort expended in cleaning, there may be survivors (see discussion of biofilm. 

Each technique has common problems that make quantitation difficult. These include (1) the nature of the surface (smooth versus pitted, flat versus irregular), (2) definition of area to be sampled, (3) amount of pressure applied to surface, and (4) the time of application. Further, one cannot be certain of complete recovery of microbes from a cotton swab. By standardizing the sampling procedure, one can improve success and make general observations that is, the operation maybe rated as good, fair, or poor.  

Because of the probability of residual microorganisms on equipment, it is important to evaluate the effectiveness of any sanitation program. Sampling sites on winery equipment should be selected to include aU points that are liable to shelter microorganisms. Of importance would be to sample direct-contact surfaces such as crushers, stemmers, presses, the interior of pipelines, conveyors, and tanks. Other areas to sample include where indirect contamination could occur such as condensation from ceilings or equipment, aerosols, and lubricants. 

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Methyl bromide has been identified as an ozone-depleting substance and is being gradually removed from world markets. Current legislation and plans call for the elimination of methyl bromide in most industrial countries by 2005, with possible exemptions for quarantine (UNEP, 1996). Currently there is an extensive search worldwide for products that are alternatives to methyl bromide (Kawakami, 1999). These alternatives are broadly defined and include components of management plans such as sanitation, monitoring, contact insecticides, heat treatments, and modified atmospheres, in addition to new fumigants (Batchelor, 1998). 

Despite the deficiencies noted above, ATP-bioluminiscence technology is used in sanitation monitoring, where immediate results are required prior to beginning operation. Presently, there are several luminometers and test kits being marketed. Once the monitor is in place, the cost per test (which includes sample collection container, swab, and reagents) is near 3. 

WHO/UNICEF (2008) Progress in drinking-water and sanitation special focus on sanitation. Joint Monitoring Programme for Water Supply and Sanitation update report. Available at http //www.wssinfo.org/en/40 MDG2008.html (June 2009)... 

Other manufacturing procedures requiring validation include cleaning, decontamination and sanitation (CDS) procedures developed for specific items of equipment/processing areas. Of particular importance is the ability of such procedures to remove bioburden. This may be assessed by monitoring levels of microbial contamination before and after application of CDS protocols to the equipment item in question. 

Current reviews of surface water monitoring data in the peer reviewed literature are lacking. The highest concentrations observed in surface waters of the United States sampled before 1984 were 394 and 120 ppb. These concentrations were observed in rivers in highly industrialized cities (Ewing et al. 1977 Pellizzari et al. 1979). Typical concentrations for most sites that are not heavily industrialized appear to range from trace levels to 22 ppb (Ohio River Valley Sanitation Commission 1980, 1982). Data from EPA s STORET database indicate that chloroform was detected in 64% of 11,928 surface water sample data points at a median concentration of 0.30 ppb (Staples et al. 1985). 

The hrefly Inciferin system is very sensitive and can be conpled to any enzymatic reaction that prodnces or nses ATP. For example, creatine phosphokinase can be determined by this method and hence be nsed in the diagnosis of myocardial infarction and mnscle disorders. The creatine phosphokinase converts AMP into ATP which then nndergoes the reaction with Inciferin as shown in Fignre 3.25. ATP pro-dnction is essential for every known life form and the firefly Inciferin system can be nsed to check for microbial life. Hence systems have been developed that use a portable luminescence workstation to monitor sanitation in food manufacturing and to check for sterile environments in technological workplaces. The system can also be applied in checking cell viability, for instance in cell cultures and to measure the toxic effects of chemicals on cells. 

The good bioavailability of orally administered ciprofloxacin obviates the need for the more expensive intravenous formulation. I.v. ciprofloxacin is only given to patients who have severe sepsis or severe nausea and vomiting. Ciprofloxacin s elimination is 50% hepatic and 50% renal. Therefore, dose reduction is recommended only in case creatinine clearance drops to < 10 ml/min. Prevention of food-borne disease requires efforts at many levels. Monitoring safety of food processing, vector control, surveillance of outbreaks, education on personal hygiene and improving sanitation and access to safe water supplies are all necessary measures to reduce the incidence of GTI. 

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. 

Other environmental monitoring data in the area Water system sanitization records ... 

If sterility test contaminant is same as routine environmental contaminant the sterility test is voided. Investigate sterility test procedures and room sanitation/sterilization methods to eliminate cause. If media-fill environmental contaminant is same as routine environmental contaminant increase the number of media-fill vials in media hll to determine the product risk potential. Review monitoring technique for possible problem. Review personnel practices, gowning, sanitation, and sterilization. 

Deionization equipment should have proper size to allow frequent regeneration. A recirculation system should also be installed in the unit that approaches the rated flow of the deionization unit. Procedures should be written to ensure that all water treatment equipment is properly operated, monitored, maintained, and sanitized on a regular basis. 

Sanitation Practices. All bottling room equipment should be sterilized each day before beginning operation of the line. Bottle rinsers, if used, must be monitored continuously during operation since they can be... 

The environment of an aseptic filling operation must be monitored and controlled. Environmental control begins with valid cleaning and sanitization procedures, then proceeds with adequacy of certified HEPA filtration and clean room procedures by personnel within the clean room, and is verified by environmental monitoring techniques. Such techniques include nonviable particulate... 

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