Purified water is a key component in the manufacturing of virtually all pharmaceutical products. Total organic carbon (TOC) is the amount of carbon found in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. Pharmaceutical water testing is comprised of several components; among which are appearance, total organic carbon, conductivity, bioburden, and endotoxin testing to ensure product quality and patient safety. Improper sampling may have a negative impact on company image, cost, productivity, ethics, and regulatory liability. SCOPE: 2.1 This SOP is applicable for all the cleaned equipment in the Pharmaceutical manufacturing plant. Cleaning validation test results can be expressed as a limit test or cover a range of analyte concentration. Eur.) Table 3 shows the results of a comparison test in which 44 samples were run at each of 22°C and 37°C, on two different media—the richer TSA that is commonly used in pharmaceutical water testing and the marginally less nutrient-rich YEA—and also low nutrient HPC for Quanti-Tray. From Microbiological analysis of water in the pharmaceutical industry to chemical and physio-chemical analysis for pharmaceutical water sampling and the testing of purified and highly purified water. 6. Sampling Plan. Analytical chemistry is the branch which is taught in almost all schools and colleges. Pharmaceutical Industry Compressed Air & Gas Testing Specifications – Pharmaceutical Industry. TOC may also refer to the amount of organic carbon in soil, or in a geological formation, particularly the source rock for a petroleum play; 2% is a rough minimum. Disinfectant Efficacy. Test the water sample for the following parameters: A typical program involves intensive daily sampling and testing of major process points for at least one month after operational criteria have been established for each unit operation, point of use, and sampling point. Monitoring and Validation of High Purity Water Systems with the LAL test for pyrogens, T.J. Novistsky, Pharmaceutical Engineering, March-April, 1984. Since WFI needs to be completely rid of microbes, the water needs to be in constant movement at 80-90°C so that microbial growth cannot occur. Water Testing. Sterilisation processes are applied to products in a number of industries, including food and beverage manufacture, but it is mainly in the pharmaceutical and medical sectors where the sampling of sterile products for testing remains an important routine task for microbiologists. Honeyman Laboratories offer Chemical analysis, Physio-Chemical analysis, Microbiological and Quantitative Endotoxin testing for all types of pharmaceutical water and steam. SOP For Sampling and Testing of Purified Water in Microbiology September 7, 2020 Admin Leave a comment Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Guidance is provided on aspects of sampling from valve design, the number, location, and placement of sample valves, sampling technique, frequency, and sample storage including delivery to the testing laboratory. From feed water to WFI to pure steam. Production of pharmaceutical water employs sequen- ... the hose when sampling the water for testing. Transfer the tube to a water bath at 50°C and allow to stand for 15 minutes. Control is not only about numbers of microorganisms recovered through bioburden testing [2] for microbiologists additionally need to understand the types of organisms present within water. 6.2 Sampling of water for Chemical analysis and Bacterial Endotoxin testing . 35 The European Pharmacopoeia (Ph. Water systems should be monitored at a frequency that is sufficient to ensure that the system is in control and continues to produce water of acceptable quality. Purified Water Testing. Both types should be assessed for bioburden, while WFI also requires bacterial endotoxin testing. Test for Heavy Metals Heat 200 ml of water sample in a glass-evaporating dish on a water bath until the volume is reduced to 20ml. if a hose is usually attached the sample should be taken at the end of the hose. For many years the method of choice was the multiple tube ‘most probable number’ (MPN) technique, in which measured volumes of the water sample are added to a series of tubes containing differential media and incubated. 4.12 Control the valve of sampling point to avoid splashing. We are concerned with two primary types of water: purified water and water for injections (WFI). USP Chapter <1231> 7 – “Water for Pharmaceutical Purposes ” recommends the usage of sampling and testing methods in “Standard Methods for Examination of Water and Wastewater”. USP Pharmaceutical Water Testing Water is widely used as a raw material, ingredient, and a solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients and intermediates, compendial articles, and analytical reagents. TVC by membrane filtration employing various methods: pharmacopoeial, HTM2030 and customer specific. Currently, conductivity and total organic carbon (TOC) are the only attributes routinely performed with online testing. The meeting agreed that further guidance on the use of the different grades of pharmaceutical water would be beneficial to the industry as the Ph Eur monographs themselves do not address some of the aspects of when particular grades should be used. Mix immediately. 33 pharmaceutical industry devotes considerable resource to the development and maintenance of water 34 purification systems. The technical and logistical PHARMACEUTICAL PURPOSES problems created by a delay in the result of such an analysis do not eliminate the user’s need for microbial specifications. Pharmaceutical Water System- SAMPLING CONSIDERATIONS. General experience with both chemical and microbiological testing of water shows that the processing of sampling, shipment and storage in a sterile container for laboratory testing changes the test results usually for the worst and delays obtaining the results until after the manufacturing step is long completed. These levels are monitored through test analysis and sampling periodically. This article addresses methods for bioburden testing. In the hypothetical pretreatment/purified water generation system (skid included), there are 21 sampling points as shown in Figures 1 through 3. Therefore, monitoring pharmaceutical-grade water systems for bioburden is important. Sampling from bore well (at initial stage) During project of a pharma facility, bore well location has finalized and from this tentative bore well sampling for one week has done and this bore well water analyzed for complete parameter including chemical and microbiological. 4.10 Spray the sampling point using 70% IPA solution and wait for 5 minutes. We also offer support services such as sample collection and data trending. 103 104 1.2 The focus of this document is on the treatment, storage and distribution of treated water used 105 in pharmaceutical applications. Nitrate Test (water analysis) To 5 ml of sample in a test tube immersed in ice, add 0.4 ml of a 10% w/v solution of Potassium Chloride, 0.1 ml of Diphenylamine solution and add drop wise with shaking 5 ml of Sulphuric Acid. 4.8 Sampling bottle shall not be opened except at the time of sampling. RESPONSIBILITY: 3.1 QA Officer is responsible for the Collection of Swab and rinses water sample. Take 12 ml from the evaporated water, add 2 ml of buffer solution pH 3.5. This can result in time-consuming additional investigations and testing to account for potential anomalies that were not considered during the PQ phase. An overlooked aspect of water system validation is the delivery of the water to its actual location of use. SAMPLING FOR PHARMACEUTICAL WATER, PHARMACEUTICAL STEAM, AND PROCESS GASES WATER SAMPLING CHAPTER • Two primary groups to monitor and control • Chemical contaminants • Biological contaminants • To understand; two topics must be discussed • Distribution of contaminants within the water purification and distribution system • Overall purposes for sampling. The two main types of sampling are direct surface sampling with swabs, which is most desirable and finally, rinse sampling 1. A hose is usually attached the sample should be assessed for bioburden important. Is responsible for the following parameters: sampling Plan is a key component the... 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