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. The sampling procedures and … Sampling Schedule of Purified Water: 2. Collect the 100ml of water sample for self analysis and 500ml of water for outside lab for microbiological analysis … There is a need to identify the source of contamination. 1 0 obj If any chemical parameter exceeds the limit, immediately inform the same QA, Production, and Engineering Department. Analyse the water samples for Microbiological analysis as per specifications. Chemical analysis: PROCEDURE: Sampling of water Sampling of water … Sampling … 1. Perform the analysis as per the current version of purified water specification. endobj Sampling Procedures for Drinking Waters 1 PURPOSE This standard operating procedure outlines details for collection of drinking water samples for chemical, microbiological and radiological analysis. 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. <> Noroviruses, are repeatedly related to poor water quality (… If you would like the entire volume, please send your email request for a zip file.. In particular, the spread of enteric viruses, e.g. 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. HOW TO COLLECT A WATER SAMPLE FOR MICROBIOLOGY EXAMINATION Created: March 26, 2015 Page 1 of 2 *Conditions Apply 1. If a hose is already connected to the port or valve, collect the sample directly from that hose. The final summary report shall be prepared at the end of the Year. It is a microbiological analytical procedure which uses samples of water and from these samples determines the concentration of bacteria. Refer Annexure-2 for preparing the Sampling Schedule. Prepare a Sampling and Analysis Plan (SAP) which describes the sampling locations, numbers and types of samples to be Talk to the lab to determine if this collection procedure is acceptable for the analytical method they plan to perform. Hold the sterile container near the sampling point. 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. endobj SUPPLY … Annexure-1: List of Sampling Points of Purified Water. Follow the procedures described below to assist in the collection of an acceptable sample and to maintain the integrity of the sample after collection. Water column sampling using dedicated sampler devices specially designed to assess the impact of offshore activities on sea water quality Groundwater sampling Collection of groundwater and analysis to international standards using a comprehensive range of equipment, including interface meters, low and high flow sampling pumps, flow through cells and calibrated field instrumentation 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. Head of the Department / Designee of respective areas & QA shall be responsible for reviewing the SOPs. Water Sampling Procedure: 1. for validated time. SAMPLING FOR MICROBIOLOGICAL ANALYSIS In case of laboratory analysis for microbiological purpose, following guidelines are adopted to collect representative water samples: Sample Bottles Pre-sterilized sampling bottles of 200 ml capacity made of pre-sterilized disposible/autoclavable plastic, or good quality soda / borosilicate glass. 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 … Analyze the TOC sample as quickly as possible on arrival at the laboratory. 5.1.3 Samples for microbiological evaluation should be collected in Pre-sterilized screw cap glass bottles. 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 … Sampling personnel shall wear clean smocks or gowns and sterile gloves prior to collecting any sample (As per area requirements). 2 Content • Introduction – What does the future hold for microbiological water AQC? Then remove the sterile strip from the bottle. Prepare the sampling schedule (Tentative) by the first working day of every New Year. 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. Analyze the sample of purified water for pathogens using filtration technique/Direct as per the current specification of Purified water. Moreover, there are many types of pathogen and each requires a unique microbiological isolation technique. Microbiologist shall wear sterilised gloves during the sampling activity. Start microbiological analysis of water as soon as possible after collection to after sampling and certainly within 24 hours. Rinse the bag twice with the sample water prior to filling and closing. Standard Operating Procedure (SOP) for sampling from different points and microbiological analysis/testing of Purified water samples in pharmaceutical plants. Flush the sample port/valve for the qualified time or volume and immediately open the labeled sample container and collect the sample. Replace the used hose onto the provided clamp after sampling so that it fully drains. 2. It represents one aspect of water quality. 4.11 Open the valve of sampling point slowly to full and drain water for approx. If sampling a body of running water, point the mouth of the bag upstream and your hands downstream to avoid contamination. Unsatisfactory environmental condition e.g. Vinlab supplies 100ml sterile plastic bottles. 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. This document is not intended for public release. Wrap the neck with aluminum foil to avoid any contamination during transportation. ^���\�L �&�BϘ�B���X�d&ǣ=�K�}. 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. {cy�L���*3i��S��e�T�����4�VS�H�¤y��2��d�����4(�"^�xnfg���kS��p�'�T�@�ů�_�:�}��$w��>�&���=������o3!�J� �H�bZ� Rinse the container at least one to two times with purified water from the sampling point. Avoid unpredictable changes in the microbial population ii. %���� 3 0 obj �d��5�ֹܵܯ�y!%r%��]iHg�3�g����U}�%�^u]}�l���Y{��������S}}����v��u���q�������""�trv���H2�O$F%�1�)���ϟe�5��ϟ�ϒ�o�ٿ�? A sample volume of 200ml should be sufficient for Faecal coliform, E. coli and Heterotrophic plate count. Utility system sampling requires additional care because samples are collected in controlled and uncontrolled areas of the facility. Water quality — Sampling for microbiological analysis. endobj Close the bottle with a cap and wrap the neck with aluminum foil and Sterilize the bottle at 121 ºC (15 lbs.) Analyze the sample of purified water for Total Viable Count using filtration technique as per the current specification of Purified Water. • Sampling points should be located in such a way that water can be sampled from reserve tanks and reservoirs, etc. <> Microbiological Analysis of Water Quality •Looking in to the 21st Century January 31, 2012 By Richard Glindon Presented by Klaus Herick. Head QA shall be responsible for the approval of SOP. A designated person shall issue the template/worksheet. Collection of purified water for Microbiological analysis: Hold the sterile container near the sampling point. Rinse with purified water. Close the container immediately and record the sampling time. Details of the type of sample containers and preservatives to be used are also included. Approximately add 15-20 ml of R2A / Plate count Agar into each Petri dishes. 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. Aseptic Technique for Microbiological Testing. <>>> 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.. 5.2.1 Pour Plate Method Dispense one ml of sample into two Petri dishes. 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. W|b1*]�y.����>'O�ak�Oߜ�~8� ���9X�;�����#|������O�en�4�O# 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��� x��[mo�6� �Aw�X_DIE�q�;�:M � This Standard Operating Procedure is applicable to the Microbiology Department. Where ever there is no drain carry the bucket to collect the water while flushing and avoid spillage of water on the floor. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 4. stream for validated time. 2 0 obj 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. 4.2.2 Enter into the respective area and visually observe the machine or part of the machine. WATER ANALYSIS SAMPLING PROCEDURES Microbiological samples: Microbiological samples should be collected in sterile plastic or glass bottles which Vinlab supplies. Phase 2 requires a root cause analysis and corrective action. Phase 2 follows the determination of data validity and investigates the water system and all potentially affected lots of products. Carry out the chemical analysis of samples as per the current version of purified water specification. 4.1.16 Again collect the swab sample and repeat procedure following Point 4.1.1 to 4.1.13. These procedures should be utilized by drinking water service providers. After completion of the analytical report, checked and approved by a designated person and after that generate the COA (if required). 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). Phase 1 focuses on the method and the analyst; the purpose of phase 1 is to verify that the data are valid. 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. %PDF-1.5 Clean 250 ml Clear glass bottles with cap for membrane filtration method or pour plate method and rinse with purified water. Officer or Executive of the Microbiology department shall be responsible for the preparation of new or revision of existing SOP. 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. Preparation of Containers for the sampling of purified water: Clean 1000 ml Clear glass bottles with a cap. Annexure-2: Sampling Schedule of Purified Water. The Laboratory Procedures for the Microbiological Analysis of Foods are available upon request. If the immediate analysis is not possible, store the sample under refrigeration at 2 to 8ºC. Open the valve of the sampling point and allow the water to drain for about 20-30 seconds. If a hose is not present, a sterilized adapter and hose may be used to sample directly from the valve/port. Wear gloves when collecting samples. 4 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. PROCEDURE FOR MICROBIOLOGICAL MONITORING OF WATER. 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. Water Sampling Procedure (with reference to ISO 5667 Part 5) (A) Assessment of Sampling Location Please take note of the conditions of the environment, sampling taps and pipes at the sampling location. If no sterile bottle is available, rinse the bottle first with hot water, then with the sample and then proceed to fill the bottle with sample. To lay down the procedure for Sampling and Testing of Purified Water. These Alert levels can be modified depending on the trend analysis done in the monitoring program. Collect the purified water sample (refer table 1) without rinsing and close it with stopper immediately. 3. Step Three Remove Faucet Screen and For Microbiological Analysis: Clean 250 ml Clear glass bottles with cap for membrane filtration method or pour plate method and rinse with purified water. 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. If the following situation(s) is/are encountered, DO NOT TAKE SAMPLES. Open tap and run to waste, allowing removal of any excess solution. drinking water samples and handling of sample preservatives. Step Two Wash Your Hands prior to taking the sample. 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. ACoP L8 recommends that sampling for Legionella should be carried out when: 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. Unwrap the aluminum foil and open the bottle taking care not to touch the inner surface and neck of the bottle. 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. 4.12 Control the valve of sampling point to avoid splashing. 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. 1. Sampling apparatus and containers shall be clean, sterile, and/or endotoxin-free as per test requirements. Where potable (drinking water) water is stored, BS8558:2015 sets out a regime where 6 monthly microbiological activity is measured. Carry the sampling containers to the sampling point as per the sampling schedule. Wear gloves and nose mask before sampling. Ensure you have read the ‘Standard drinking water sampling procedure – microbiological’. Microbiological Sampling and Testing May 2019 Science Staff Office of Public Health Science 1. B Analyst error should be rare. Unwrap the aluminum foil and open the bottle taking care not to touch the inner surface and neck of the bottle. If you are sampling more than one location you need a separate sample bottle for each location. 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. Annexure-3: Sampling Details of Purified Water. 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”. Sanitize the hands with 70 % v/v IPA. If the hose is not connected but is provided, attach the hose using procedures applicable for that system. • 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. Bacteriological water analysis is a method of analysing water to estimate the numbers of bacteria present and, if needed, to find out what sort of bacteria they are. Domestic water systems are supplied with water fit to drink, so ACoP L8 advices that regular microbiological sampling is not required. 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. If sampling from a water faucet, run the faucet for 1 minute before obtaining a sample. Fill the bottle almost to the top, leaving a gap for mixing (approx 5 mm). Immediate resampling of the specific location where the OOT/OOS occurred must be performed, to rapidly assess the condition of the system. Note: Before sampling, the aluminum foil covering the sampling point should be removed. Before analysis, Register/log the sample, and generate/issue the worksheet, or the template. • There should be at least one sampling point directly after the clean-water Carefully replace the cap. 1 minute. 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. These stored samples should be analyzed within 6 hours. Microbiological samples should be collected in sterile plastic or glass bottles. 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. OBJECTIVE:To lay down a procedure for microbiological monitoring of raw water and purified water. After completion of the test, record the results in the datasheet and also enter the results in the respective software/module. Analyze the sample as quickly as possible on arrival at the laboratory. 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. – How can we meet the demands microbiological water AQC in the future? 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. surroundings dusty, covered with debris, or poorly ventilated; 2. Close the valve and bring the samples to the laboratory and make an entry in the purified water inward register. 3. Use sodium hypochlorite solution (1g/L free chlorine) or ethanol/isopropanol 70% v/v. Water system sanitization methods require assessment. Alert levels are always lower than Action levels. Ensure that the required contact time for the sanitizer has been achieved. A sample volume of 250 mL should be sufficient for Total coliform, Faecal coliform, E. coli and Heterotrophic plate count 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). Close the bottle with a cap and wrap the neck with aluminum foil and Sterilize the bottle at 121 ºC (15 lbs.) PathWest Laboratory Medicine WA Manual: Water Examination Procedures Title: Collection And Transportation Instructions For Water Sampling Document Number: MWP119 Version Number: 1.7 Document Owner: Woodward, Robin Page 1 of 7 Date Issued: 14-Dec-2017 COLLECTION AND TRANSPORTATION INSTRUCTIONS FOR MICROBIOLOGICAL WATER SAMPLING 1. Collect the purified water sample (refer table 1) without rinsing and close it with stopper immediately. Faecal contamination of water is routinely detected by microbiological analysis. 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. Write the sampling details or affix the label on the bottle as per Annexure-3. Quality Monitoring of Water for Pharmaceutical Use. RESPONSIBILITY Quality Control Executive / Officer ACCOUNTABILITY Quality Assurance Head.