Water Treatment System And Process In Gmp Pdf
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- Good Manufacturing Practices Guidance Document
- ISO Standard for the Production of Pharmaceutical Water
- Water Release Testing for GMP Manufacturing
Pharmaceutical Water is, perhaps, the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Good Manufacturing Practices Guidance Document
Most people take water for granted. In the United States, Japan and in Western Europe, all that an individual needs to do is turn on the tap at any time in the day or night to get clean, potable water.
Water is used for drinking, cooking, washing and myriad other tasks. The reality is, however, that those who have abundant supplies of good, clean water should consider themselves blessed. There are still places in the world where water must be drawn from public wells and carried home, and others where the people are not even that fortunate.
Of course, even in places where water quality is considered good, problems crop up. Following that outbreak, testing for Cryptosporidium in persons with diarrhea increased substantially in some areas of Wisconsin; by Aug. For example, during the later years of the Clinton Administration, they proposed lowering the standards for certain elements. The Bush Administration held up implementation to allow for additional study.
Food processors need large quantities of good quality water for a range of operations, including blending or mixing, cleaning, ice making, steam production and product transport. It is absolutely essential that food processors take steps to assure that the water and water systems in their plants are safe, wholesome and under their control.
The following has been drawn from the U. Each processor shall have and implement a sanitation standard operating procedure SSOP that addresses sanitation conditions and practices before, during, and after processing. The SSOP shall address: 1 Safety of the water that comes into contact with food or food contact surfaces or that is used in the manufacture of ice…. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality.
Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food packaging materials or for employee sanitary facilities. The assumption is that these are safe sources but this needs to be verified.
There are many operations around the world that draw from rivers or other sources and must treat water on site to assure its sanitary quality.
In the U. Treatment plants must, therefore, be an integral part of these facilities. In the early s, two outbreaks of botulism that were traced to canned salmon processors underscored the need for both good sanitation and good water quality in these operations. Several operations installed reservoirs for chlorinating can cooling water. Using information developed by the National Food Processors Association, the waters were treated to achieve a 5-log reduction of spores of Clostridium botulinum in an effort to reduce the potential hazard from water.
They may be passing water through a reverse osmosis RO system to ensure that the water is cleaner or of better chemical quality when used as an ingredient. Other might chlorinate or ozonate their process waters, and there are those who pass water through ultraviolet UV light systems.
The water must also be delivered to different areas within the plant at with sufficient pressure to do the job that needs to be done. For example, if a line contains a washer or washing step, the water pressure must be high enough to properly wash the product or unit operation. Operations that have problems with poor water pressure may be forced to install hold tanks with pumps to assure both adequate supply and pressure.
Most food processors use hot water for cleaning and other operations. Processors need to assure that they establish systems that allow them to heat sufficient quantities of water for all their needs. Ideally, these systems should allow them to control temperature to within the necessary parameters. For example, cleaners work best within set temperature ranges. If an operation is involved with the production of meat or meat products, U.
Department of Agriculture USDA regulations mandate that there be sanitizing stations where the water is held at 82F or above to assure that utensils may be properly sanitized. The first step for a processor is to be sure that there are complete and updated plumbing diagrams. Processors need to understand how fresh water comes into the factory, its source and, perhaps, most important, that there are no cross-connections with sewage or waste water lines.
This is something that most new plants would have, but is not as common in older facilities. Understanding water and wastewater flow is absolutely essential. Experience shows that as plants expand or are modified, these operations tend not to make the necessary changes to their plumbing blueprints.
Processors should also examine all water lines and water handling systems to be sure that there is no potential for contamination within the operation. Do you have back-flow prevention devices on water lines? Are there air gaps between spigots or hoses and water sources? Are hoses handled properly so that their use in the process will not contaminate product, equipment or ingredients? Operators need to teach plant staff how to handle and store hoses.
Line workers often drag hoses across the floor, over equipment and use them to fill blending or mix tanks. Wastewater and soil end up in the mix. Perhaps the greatest potential concern for contamination is cross-connections. Processors need to verify that plumbing diagrams are both accurate and current. The diagrams should show no cross- connections.
As noted, processors should conduct an audit of their water and plumbing systems. Water lines remain clean because they are constantly flushed. Unused lines off a main or a large reservoir below the floor will not be flushed properly. Water remaining in these dead areas can create potential health and quality problems. For example, a processor who relies on clean water for blending might experience off-flavor problems if there is a dead spot upstream of the blend tanks.
Back-flow devices are designed to prevent dirty or contaminated water from flowing towards a clean source. They allow water to flow in one direction only. Water sources and tanks must be separated. Indeed, back-flow prevention has become a hot button in third-party audits. The plumbing diagrams alluded to earlier should include all water systems and the locations of the back-flow devices in the system.
There should also be an easily accessible back-flow device on all water mains coming into the plant. There are plants where the lines are under ground and, therefore, inaccessible. These companies conduct pressure tests on the devices and make any adjustments that are needed. Their report will also serve as an auditable record to ensure that the work is being done.
There is a sense that plant workers and their managers believe that frozen water cannot be a source of contamination. In many operations, especially in the seafood industry, water for chilling foods or blending is produced in large icemakers that deposit the ice in bins. This is not a good practice since that ice may be used to chill foods.
The icemakers themselves also need to be cleaned and sanitized on a regular schedule. Microbiologist Cliff Coles of California Microbiological Consulting has found a number of operators to have filthy icemakers. In fact, most still have the original cartridge filter in place that was there 20 years ago.
They should also establish a regular maintenance program for the water filters. A sticker or tag should be placed on the filter that can be easily seen that indicates when the filter was serviced and when it is due to be serviced again. Records of filter maintenance and icemaker cleaning and sanitizing should be maintained in the plant to document that the work has been done. To further assure the quality of ice used in production, processors are now treating water used for ice making with ozone.
This helps assure that the ice is of good microbiological quality and can even help control the microbial load on certain products. Water Quality Analysis All food processors should test water in the plant from different outlets at least once each year—and preferably more often. Operators should collect water samples from the farthest faucet from the line in the facility and preferably from the cold side.
This should be done even if water is obtained from a city water system. The water quality as it leaves a treatment plant and its condition when it gets to your plant may vary. This is especially true in cities where pipelines are old. If the water pipes are iron, it is quite easy to pick up that metal from the lines.
High iron water, whether from old pipes or a natural source, is quite easy to detect. All one needs do is look for iron stains wherever there are leaks or drips.
Along these lines, processors should always request that the city provide them with water test results. These results are those obtained at the water treatment facilities. Having city water records does not preclude the processor from testing water from their own operations, however. If water from multiple sources is being used wells, city or wherever , be sure that samples from each source are tested.
Both microbiological and chemical parameters should be tested. Knowing the chemistry of the water coming into the plant will help in other areas. Microbial analyses should include total counts and coliforms. If there are concerns that the water may have been contaminated with runoff from fields or elsewhere, you may want to look for pathogens or parasites. Chemical tests should include pH, water hardness, heavy metals, pesticides, iron and nitrates.
Water samples for complete chemical analyses should collected at least once a year and submitted to a recognized water testing laboratory. Testing the microbiological quality of the water should be done more frequently. Be sure to establish documented programs for water sampling.
These should include how to sample, how often to sample and where to sample. These procedures should also include what tests should be done and the methods for doing the work. Maintain all your records and testing procedures in a separate file or binder so that test results may be quickly and easily accessed. Installing sample ports on water lines is a good idea, provided they are installed properly.
If water samples are being collected for microbiological testing and the water is chlorinated, be sure that the sampling program includes a step to neutralize any residual chlorine.
ISO Standard for the Production of Pharmaceutical Water
Most people take water for granted. In the United States, Japan and in Western Europe, all that an individual needs to do is turn on the tap at any time in the day or night to get clean, potable water. Water is used for drinking, cooking, washing and myriad other tasks. The reality is, however, that those who have abundant supplies of good, clean water should consider themselves blessed. There are still places in the world where water must be drawn from public wells and carried home, and others where the people are not even that fortunate.
storage and distribution processes is a major concern. Unlike other General considerations for water purification systems. 6. WPU; guidance on GMP regarding the quality management of water systems; water.
Water Release Testing for GMP Manufacturing
Good Manufacturing Practice for Drugs Revision. The Good Manufacturing Practice for Drugs Revision , adopted at the executive meeting of the Ministry of Health on October 19, , is hereby promulgated and shall go into effect as of March 1, Chen Zhu. Minister of MOH.