Annexure-2: Sampling Schedule of Purified Water. Start microbiological analysis of water as soon as possible after collection to after sampling and certainly within 24 hours. If sampling from a water faucet, run the faucet for 1 minute before obtaining a sample. A sample volume of 250 mL should be sufficient for Total coliform, Faecal coliform, E. coli and Heterotrophic plate count Follow the procedures described below to assist in the collection of an acceptable sample and to maintain the integrity of the sample after collection. Head QA shall be responsible for the approval of SOP. Phase 2 requires a root cause analysis and corrective action. Then remove the sterile strip from the bottle. Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Open tap and run to waste, allowing removal of any excess solution. Rinse the bag twice with the sample water prior to filling and closing. Step Three Remove Faucet Screen and Rinse with purified water. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> HOW TO COLLECT A WATER SAMPLE FOR MICROBIOLOGY EXAMINATION Created: March 26, 2015 Page 1 of 2 *Conditions Apply 1. Hold the sterile container near the sampling point. 1 0 obj If the immediate analysis is not possible, store the sample under refrigeration at 2 to 8ºC. Analyze the sample of purified water for pathogens using filtration technique/Direct as per the current specification of Purified water. 5.2.1 Pour Plate Method Dispense one ml of sample into two Petri dishes. Approximately add 15-20 ml of R2A / Plate count Agar into each Petri dishes. Flush water through sampling point for 5 – 20 Seconds. Alert levels are specific for a given facility and are established on the basis of a baseline developed under an activity monitoring program. These guidelines collate and standardise PathWest’s microbiological analysis methods as part of the sampling, testing and analysis agreement between Western Australian Local Governments and the Department of Health. These stored samples should be analyzed within 6 hours. Collect your water sample early in the week – Monday to Thursday –to give enough time to get to the laboratory and to be analyzed within 24-30 hours. Talk to the lab to determine if this collection procedure is acceptable for the analytical method they plan to perform. 5.1.3 Samples for microbiological evaluation should be collected in Pre-sterilized screw cap glass bottles. 4.13 Carry out sampling step 4.14 and 4.19 as rapidly as possible to avoid exposure of the sample to the external environment. Water quality — Sampling for microbiological analysis. Please select the appropriate link in the table below to send your request via email, or contact Health Canada's publication office to make your request.. If you would like the entire volume, please send your email request for a zip file.. Clean 250 ml Clear glass bottles with cap for membrane filtration method or pour plate method and rinse with purified water. endobj Quality Monitoring of Water for Pharmaceutical Use. Purified water quality parameter trending shall be done on the Monthly basis, trend charts shall be reviewed and a conclusion shall be made (if required). Related: SOP for Corrective and Preventive Action (CAPA), List of SOP for Pharmaceutical Quality Assurance, SOP on Handling of Incidents and Deviations, SOP ON Receipt, Issue & Control Of Lab Chemicals, SOP for Qualification of Quality Control analyst, SOP On Safety In Quality Control Laboratory, SOP for Corrective and Preventive Action (CAPA), ← SOP For Handling of Power Failure in Plant, List of ICH Quality Guidelines for Pharmaceutical Industry, SOP List For Pharmaceutical Quality Assurance, Chemical TOC /Oxidisable Substance Total Microbial Counts Presence of Pathogens, Total microbial counts Presence of Pathogens. MICROBIOLOGICAL WATER SAMPLING - BASIC PROCEDURES Taking a Routine Bacteria Sample Properly Step One Do Not Rinse The Bottle The powder in the bottle is meant to be there and will not contaminate your sample. Head of the Department / Designee of respective areas & QA shall be responsible for reviewing the SOPs. Microbiological Analysis of Water Quality •Looking in to the 21st Century sigma-aldrich.com January 31, 2012 By Richard Glindon Presented by Klaus Herick. Use sodium hypochlorite solution (1g/L free chlorine) or ethanol/isopropanol 70% v/v. It is important to routinely identify organisms recovered from water systems when: Waterborne organisms may be detrimental to finished products or processes in which the water is used. The precautions taken to avoid contamination must be such that they do not affect any microorganisms that are to be revealed in the test (water analysis). Sampling water for subsequent analysis is often considered to be somewhat easier than sampling, say, soils for two main reasons: (i) water tends to be more homogeneous than soils, there is less point-to-point variability between two samples collected within the same vicinity, (ii) it is often physically easier to collect water samples because it can be done with pumps and hose lines, (iii) known volumes of water can … Annexure-1: List of Sampling Points of Purified Water. Flush the sample port/valve for the qualified time or volume and immediately open the labeled sample container and collect the sample. Wear gloves and nose mask before sampling. drinking water samples and handling of sample preservatives. Faecal contamination of water is routinely detected by microbiological analysis. • There should be at least one sampling point directly after the clean-water Step Two Wash Your Hands prior to taking the sample. After completion of the test, record the results in the datasheet and also enter the results in the respective software/module. The Laboratory Procedures for the Microbiological Analysis of Foods are available upon request. OBJECTIVE To lay down a procedure for microbiological monitoring of raw water and purified water SCOPE: This SOP shall be applicable for sampling and microbial analysis of raw and purified water from all user points. 4.1.16 Again collect the swab sample and repeat procedure following Point 4.1.1 to 4.1.13. Perform the analysis as per the current version of purified water specification. Sampling Instructions This method of sample collection is acceptable for EPA analytical methods 1622 and 1623 when sending water samples in to the laboratory without filtering in the field. Food Safety and Inspection Service: •Sampling methods •Assessing sampling plans and testing methods •Method validations and laboratory quality assurance •FSIS testing programs, methods and pathogen-specific issues to consider •Industry testing activities 2 Today’s Presentation. If a hose is not present, a sterilized adapter and hose may be used to sample directly from the valve/port. %���� Sampling personnel shall wear clean smocks or gowns and sterile gloves prior to collecting any sample (As per area requirements). Microbial levels, specified in the standard operating procedure or specifications, when exceeded should result in an investigation to ensure that the process is still within control. 4.2 Rinse water sampling: 4.2.1 After cleaning, the Production Officer shall inform to QA Officer for the collection of the rinse water sample. Annexure-3: Sampling Details of Purified Water. Chemical analysis: If any chemical parameter exceeds the limit, immediately inform the same QA, Production, and Engineering Department. x��[mo�6� �Aw�X_DIE�q�;�:M � Collect the purified water sample (refer table 1) without rinsing and close it with stopper immediately. If a hose is already connected to the port or valve, collect the sample directly from that hose. Microbiological samples should be collected in sterile plastic or glass bottles. The changes may occur in the bacterial content of water on storage can be reduced to a minimum by ensuring that samples are not exposed to light and are kept cool. It is a microbiological analytical procedure which uses samples of water and from these samples determines the concentration of bacteria. If you are sampling more than one location you need a separate sample bottle for each location. This document is not intended for public release. Collect the 100ml of water sample for self analysis and 500ml of water for outside lab for microbiological analysis … Wash 125 ml Amber glass or suitable bottles with a stopper with 2.0 M HCL or 2.0% nitric acid and rinse with purified water and dry the bottles at 105 ºC for at least one hour. Unwrap the aluminum foil and open the bottle taking care not to touch the inner surface and neck of the bottle. make the schedule in such manner that generation point (For Chemical & Microbiology Analysis) & return loop (For Microbiology Analysis only) covered on a daily basis and other useful points (For Microbiology Analysis only) to be covered in rotation within a month. W|b1*]�y.����>'O�ak�Oߜ�~8� ���9X�;�����#|������O�en�4�O# Open the valve of the sampling point and allow the water to drain for about 20-30 seconds. Prepare a Sampling and Analysis Plan (SAP) which describes the sampling locations, numbers and types of samples to be • Sampling points should be located in such a way that water can be sampled from reserve tanks and reservoirs, etc. Sanitize the hands with 70 % v/v IPA. ACoP L8 recommends that sampling for Legionella should be carried out when: Carry out the chemical analysis of samples as per the current version of purified water specification. Replace the used hose onto the provided clamp after sampling so that it fully drains. PROCEDURE: Sampling of water Sampling of water … Fill the bottle almost to the top, leaving a gap for mixing (approx 5 mm). – How can we meet the demands microbiological water AQC in the future? This Standard Operating Procedure is applicable to the Microbiology Department. Sampling … The final summary report shall be prepared at the end of the Year. Analyze the sample of purified water for Total Viable Count using filtration technique as per the current specification of Purified Water. A designated person shall issue the template/worksheet. Details of the type of sample containers and preservatives to be used are also included. Where ever there is no drain carry the bucket to collect the water while flushing and avoid spillage of water on the floor. If the immediate analysis is not possible to acidify the sample with a 2-3 drop of 2.0 M HCL and store the sample under refrigeration at 2 to 8ºC. Close the valve and bring the samples to the laboratory and make an entry in the purified water inward register. Water Sampling Procedure: 1. It represents one aspect of water quality. If the Total bacterial count exceeds the Alert limit/Action limit, immediately inform the same to QA and Engineering personnel and investigation shall be done as per the SOP for “Handling of microbial Excursion in Water and Environment”. 1. Immediate resampling of the specific location where the OOT/OOS occurred must be performed, to rapidly assess the condition of the system. 4 0 obj Carefully replace the cap. Domestic water systems are supplied with water fit to drink, so ACoP L8 advices that regular microbiological sampling is not required. WATER ANALYSIS SAMPLING PROCEDURES Microbiological samples: Microbiological samples should be collected in sterile plastic or glass bottles which Vinlab supplies. B Unwrap the aluminum foil and open the bottle taking care not to touch the inner surface and neck of the bottle. These Alert levels can be modified depending on the trend analysis done in the monitoring program. In particular, the spread of enteric viruses, e.g. Collection of purified water for Microbiological analysis: Hold the sterile container near the sampling point. Phase 1 focuses on the method and the analyst; the purpose of phase 1 is to verify that the data are valid. 4.11 Open the valve of sampling point slowly to full and drain water for approx. The sampling procedures and … Microbiologist shall wear sterilised gloves during the sampling activity. Preparation of Containers for the sampling of purified water: Clean 1000 ml Clear glass bottles with a cap. For Microbiological Analysis: Clean 250 ml Clear glass bottles with cap for membrane filtration method or pour plate method and rinse with purified water. • In systems with more than one water source, the locations of the sampling points should take account of the number of inhabitants served by each source. These procedures should be utilized by drinking water service providers. �d��5�ֹܵܯ�y!%r%��]iHg�3�g����U}�%�^u]}�l���Y{��������S}}����v��u���q�������""�trv���H2�O$F%�1�)���ϟe�5��ϟ�ϒ�o�ٿ�? Close the container immediately and record the sampling time. Write the sampling details or affix the label on the bottle as per Annexure-3. Note: Before sampling, the aluminum foil covering the sampling point should be removed. Where potable (drinking water) water is stored, BS8558:2015 sets out a regime where 6 monthly microbiological activity is measured. 4. 3 0 obj Fill the containers with 1000 ml and 125 ml or up to the neck of purified water for chemical and TOC analysis respectively, and close the lid immediately. Aseptic Technique for Microbiological Testing. Close the bottle with a cap and wrap the neck with aluminum foil and Sterilize the bottle at 121 ºC (15 lbs.) SUPPLY … Unsatisfactory environmental condition e.g. It is impractical to attempt the routine isolation of pathogens because they are present in relatively small numbers compared with other types of micro-organism. Wear gloves when collecting samples. Wrap the neck with aluminum foil to avoid any contamination during transportation. Close the bottle with a cap and wrap the neck with aluminum foil and Sterilize the bottle at 121 ºC (15 lbs.) 4.12 Control the valve of sampling point to avoid splashing. Sampling apparatus and containers shall be clean, sterile, and/or endotoxin-free as per test requirements. It is important to note that you don’t have to exceed specification in order to submit a result for identification, it’s a best practice to document and select and identify representative flora from the system. Surface water sampling methods and analysis — technical appendices Standard operating procedures for water sampling- methods and analysis Looking after all our water needs Department of Water … Analyst error should be rare. To lay down the procedure for Sampling and Testing of Purified Water. 7`rV�XH���ق�*�r��θ �NMsp�^%B�+$��3�V�&�y�J09;��������;�[KeR)����XA_�ώ�z5]�Un6)���\��ٻ���O���T�E���\J0^5�4?���xE��� Vinlab supplies 100ml sterile plastic bottles. After completion of the analytical report, checked and approved by a designated person and after that generate the COA (if required). Avoid unpredictable changes in the microbial population ii. Alert levels are always lower than Action levels. Correct sampling procedures as instructed by international standard protocols must be adhered to; Routine microbiological testing of drinking water supplies, recreational waters, and environmental waters is essential for the protection of public health ; Programme of testing. 2 Content • Introduction – What does the future hold for microbiological water AQC? SCOPE:This SOP shall provide the procedure for sampling and testing of raw water and purified water from all the user points and all the points across the critical functions in the water purification process. 6.0 PROCEDURE FOR ANALYSIS OF WATER SAMPLE: Carry out the determination under conditions designed to avoid extrinsic microbial contamination of the water sample for the analysis. Before analysis, Register/log the sample, and generate/issue the worksheet, or the template. If sampling a body of running water, point the mouth of the bag upstream and your hands downstream to avoid contamination. endobj If the following situation(s) is/are encountered, DO NOT TAKE SAMPLES. Analyse the water samples for Microbiological analysis as per specifications. stream Sampling Schedule of Purified Water: Utility system sampling requires additional care because samples are collected in controlled and uncontrolled areas of the facility. 3. 2. Noroviruses, are repeatedly related to poor water quality (… surroundings dusty, covered with debris, or poorly ventilated; 2. Good water quality is important in many settings, including those found for all drinking water systems, during food production and in fresh- and seawater for recreation and bathing activity. Ensure that the required contact time for the sanitizer has been achieved. Rinse the container at least one to two times with purified water from the sampling point. In water systems with inadequate quality control and sanitation, water could act as a vehicle for pathogenic microorganisms that originate from the faeces of wildlife including birds, livestock and pet animals, as well as humans. Collect the purified water sample (refer table 1) without rinsing and close it with stopper immediately. <> A sample volume of 200ml should be sufficient for Faecal coliform, E. coli and Heterotrophic plate count. {cy�L���*3i��S��e�T�����4�VS�H�¤y��2��d�����4(�"^�xnfg���kS��p�'�T�@�ů�_�:�}��$w��>�&���=������o3!�J� �H�bZ� Phase 2 follows the determination of data validity and investigates the water system and all potentially affected lots of products. 1. Refer Annexure-2 for preparing the Sampling Schedule. %PDF-1.5 Prepare the sampling schedule (Tentative) by the first working day of every New Year. 4.2.2 Enter into the respective area and visually observe the machine or part of the machine. Wipe any visible dust from the exterior of the sample port or valve using a lint-free wipe/cloth moistened with an approved sanitizer – do not spray or wipe the interior of the port or valve. 1 minute. 2 0 obj ISO 19458:2006 provides guidance on planning water sampling regimes, on sampling procedures for microbiological analysis and on transport, handling and storage of samples until analysis begins. endobj 5.1.4 For a sampling of Treated Raw water (May contain chlorine), add 0.1 ml of 5 % sodium thiosulphate solution in the bottles before sterilization. Water system sanitization methods require assessment. for validated time. for validated time. Carry the sampling containers to the sampling point as per the sampling schedule. 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