Water quality can impact diagnostic instrument performance and patient results. Contaminants like bacteria, ions, and organics can interfere with assays. Purification technologies like reverse osmosis, ultrafiltration, and electro-deionization are used to produce high purity water for clinical analyzers. Strict quality standards help ensure water does not introduce errors, but biofilms can still form within instruments. Technicians must carefully monitor quality controls, troubleshoot issues, and maintain water purification systems.
The document discusses water purification for pharmaceutical use. It describes various types of water (e.g. purified water, highly purified water, water for injection) and their specifications. The purification process involves multiple validation phases to demonstrate the system can consistently produce water meeting specifications. Quality must be controlled during production, storage and distribution to prevent microbial or chemical contamination.
The document discusses pharmaceutical water systems and quality control. It describes the types of water systems used in manufacturing, including raw, potable, purified and sterile waters. It outlines the regulatory, quality and engineering aspects of pharmaceutical water systems. The quality aspects section details water quality measurements, microbial limits, and system sanitization methods. The presentation emphasizes that properly designed, operated and maintained water systems are required to consistently produce water that meets regulatory standards for pharmaceutical use.
Dialysis water treatment equipment cleaning and disinfectionSomaia Alakhras
This document provides guidelines for cleaning and disinfecting equipment used to treat dialysis water in hemodialysis units. It recommends cleaning and disinfecting reverse osmosis systems, portable reverse osmosis systems, and reverse osmosis distribution loops on specific schedules depending on the component. Procedures should be documented on log sheets and follow manufacturer guidelines for chemicals, dosages, temperatures, and contact times. The guidelines aim to standardize practices across dialysis units in BC to support best practices and quality patient outcomes.
This standard operating procedure establishes a uniform process for collecting wastewater samples for compliance with permit requirements. It outlines safety gear for samplers, proper handling of preservatives, and ensuring representative samples by avoiding contamination. The SOP specifies collecting the required type of sample, parameters to analyze based on permit limits, preparing samples for shipping to the laboratory, and documentation and data reporting procedures.
This document provides guidance on environmental sampling fundamentals. It discusses the importance of developing sampling plans based on data quality objectives and collecting representative samples. Proper sampling techniques include sampling the least contaminated sites first, avoiding site disturbances, and using clean equipment and containers. The document also covers grab versus composite samples, potential issues during storage and transport, equipment calibration, and quality control measures like blanks, duplicates, and spikes to assess precision and identify potential contamination. Maintaining quality assurance is important to control errors and ensure high quality data.
The EPA document provides guidelines for regulatory monitoring and testing of water and wastewater sampling in South Australia. It outlines the steps in developing an effective monitoring plan, preparing for sampling events, procedures for sample collection and field testing, and quality control measures. The document aims to ensure sampling is consistent and provides representative data that can be used to assess compliance with environmental regulations.
This document provides an operations manual for water quality analysis. It discusses good laboratory practices and quality assurance protocols that should be followed, including proper handling of chemicals, cleaning of glassware, measurement techniques, and maintenance of laboratory equipment. Standard analytical procedures for over 30 water quality parameters are also described. The manual establishes guidelines for sample receipt, storage, analysis, reporting results, and validating data. Its aim is to help water testing laboratories obtain reliable and comparable water quality information through consistent application of quality control procedures.
Microbial analysis of water system and endotoxin estimationashapatel676
In Pharmaceutical different grades of waters are used and they all must be tested firest before using it for manufacturing any products. Products sometimes get contaminated because of presence of endotoxins so they mus be checked by performing BET test
The document discusses water purification for pharmaceutical use. It describes various types of water (e.g. purified water, highly purified water, water for injection) and their specifications. The purification process involves multiple validation phases to demonstrate the system can consistently produce water meeting specifications. Quality must be controlled during production, storage and distribution to prevent microbial or chemical contamination.
The document discusses pharmaceutical water systems and quality control. It describes the types of water systems used in manufacturing, including raw, potable, purified and sterile waters. It outlines the regulatory, quality and engineering aspects of pharmaceutical water systems. The quality aspects section details water quality measurements, microbial limits, and system sanitization methods. The presentation emphasizes that properly designed, operated and maintained water systems are required to consistently produce water that meets regulatory standards for pharmaceutical use.
Dialysis water treatment equipment cleaning and disinfectionSomaia Alakhras
This document provides guidelines for cleaning and disinfecting equipment used to treat dialysis water in hemodialysis units. It recommends cleaning and disinfecting reverse osmosis systems, portable reverse osmosis systems, and reverse osmosis distribution loops on specific schedules depending on the component. Procedures should be documented on log sheets and follow manufacturer guidelines for chemicals, dosages, temperatures, and contact times. The guidelines aim to standardize practices across dialysis units in BC to support best practices and quality patient outcomes.
This standard operating procedure establishes a uniform process for collecting wastewater samples for compliance with permit requirements. It outlines safety gear for samplers, proper handling of preservatives, and ensuring representative samples by avoiding contamination. The SOP specifies collecting the required type of sample, parameters to analyze based on permit limits, preparing samples for shipping to the laboratory, and documentation and data reporting procedures.
This document provides guidance on environmental sampling fundamentals. It discusses the importance of developing sampling plans based on data quality objectives and collecting representative samples. Proper sampling techniques include sampling the least contaminated sites first, avoiding site disturbances, and using clean equipment and containers. The document also covers grab versus composite samples, potential issues during storage and transport, equipment calibration, and quality control measures like blanks, duplicates, and spikes to assess precision and identify potential contamination. Maintaining quality assurance is important to control errors and ensure high quality data.
The EPA document provides guidelines for regulatory monitoring and testing of water and wastewater sampling in South Australia. It outlines the steps in developing an effective monitoring plan, preparing for sampling events, procedures for sample collection and field testing, and quality control measures. The document aims to ensure sampling is consistent and provides representative data that can be used to assess compliance with environmental regulations.
This document provides an operations manual for water quality analysis. It discusses good laboratory practices and quality assurance protocols that should be followed, including proper handling of chemicals, cleaning of glassware, measurement techniques, and maintenance of laboratory equipment. Standard analytical procedures for over 30 water quality parameters are also described. The manual establishes guidelines for sample receipt, storage, analysis, reporting results, and validating data. Its aim is to help water testing laboratories obtain reliable and comparable water quality information through consistent application of quality control procedures.
Microbial analysis of water system and endotoxin estimationashapatel676
In Pharmaceutical different grades of waters are used and they all must be tested firest before using it for manufacturing any products. Products sometimes get contaminated because of presence of endotoxins so they mus be checked by performing BET test
This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
The document discusses water systems and purification methods used in pharmaceutical manufacturing. It introduces different grades of water quality (e.g. purified water, water for injections) and their applications. Common water contaminants are outlined. Water purification systems may use various pretreatment steps and methods like filtration, softening, and disinfection. Proper design, operation, and maintenance of water systems is required to reliably produce water of the necessary quality.
IQ Academy Lunch & Learn Webinar | Cost Effective Water Quality Monitoring wi...IQ_UK
The document provides details of upcoming branch events for various quarrying associations in September. It also provides information on an upcoming webinar titled "Water Quality Monitoring: Making it High Quality and Cost Effective" presented by Dr. Craig Speed. The webinar will discuss how to optimize the quality of water quality monitoring programs while reducing costs to achieve cost effectiveness. It will cover monitoring design, quality control and quality assurance measures, and how to strategically reduce sampling frequency and parameters to lower expenses. A case study example is also provided.
This document provides information on water quality monitoring at the Geltec pharmaceutical manufacturing facility. It discusses the different types of water used - raw, potable, and purified water - and the critical quality parameters tested for each on a monthly basis. Methods for microbiological testing include membrane filtration for purified water and pour plating for raw and potable water. Specific microorganisms like E. coli and Pseudomonas are also tested for using various culture media. Alert and action limits are defined for parameters and appropriate corrective actions are outlined in the event of out-of-specification results.
The document discusses validation of analytical methods used in cleaning validation. It covers parameters assessed in analytical method validation like specificity, linearity, range, accuracy, precision, LOD, LOQ. It also discusses method validation, cleaning validation, levels of cleaning, cleaning process validation, typical analytical procedures and their applicability. Key aspects of validation covered include equipment and personnel qualification, microbiological considerations, documentation, sampling, rinsing, rinse samples, detergents used and establishment of acceptable limits.
This standard operating procedure describes the process for collecting surface water samples from Carter Creek on the Texas A&M University golf course. Samples will be collected using a dipper sampler and bailer sampler to obtain representative samples. After collection, samples will be tested for coliform bacteria and other water quality parameters. Proper preservation, handling, and documentation procedures will be followed to maintain sample integrity. Quality control samples like rinsates will also be collected and analyzed.
The document provides guidance on water quality sampling procedures including:
1) Laboratory preparations such as preparing sample containers, reagents, and field instruments.
2) Procedures for collecting water samples including using appropriate containers, labeling, and preservation techniques.
3) Guidance on collecting special samples like dissolved oxygen samples and how to collect and preserve composite samples.
Analytical process control bernard - 11.07.12Bosco Mbonimpa
The document discusses internal quality control (IQC) procedures for qualitative tests in a laboratory. IQC refers to the regular testing of quality control material along with patient samples, comparing the results to established statistical limits, and rejecting patient results if quality control is outside of limits. The most common laboratory error is transcription errors. Sources of error must be ruled out by repeating tests if unusual patterns are encountered. Quality control is important for blood transfusion services, rapid infectious disease tests, and all laboratory tests to monitor quality and ensure accurate results.
Principles and Instrumentation of QC Equipments by Sourav SharmaSourav Sharma
1. A conductivity meter works by applying an alternating current between two electrodes and measuring the resulting voltage. It uses this measurement to calculate conductance and then conductivity based on the cell constant.
2. Conductivity is a measure of a solution's ability to conduct an electric current and is proportional to the total dissolved ions in the solution. It is a common method used for quality control.
3. Modern conductivity cells use a 4-pole design which applies current to outer electrodes and measures voltage between inner electrodes to minimize polarization and interferences. This provides more reproducible results.
Specialty gases: essential for research, production & quality controlLinde Gas Benelux
Laboratories all around the world stand or fall by their reputation for accuracy and quality control. Pivotal to this performance is the quality, purity and composition of the spectrum of gases harnessed every day to accomplish laboratory tasks.
Rapid advancements in production processes across all industry sectors, as well as healthcare, have obliged laboratories to keep up with these changes, while remaining flexible and making allowances for future requirements. Against this background, a variety of role-specific specialised laboratory types have emerged, each addressing specific industry needs.
The document characterizes emissions of dioxins and furans from ethylene dichloride, vinyl chloride monomer and polyvinyl chloride facilities in the United States. Testing was conducted on various process streams including water, stack emissions, and products. Testing showed detectable levels of dioxins and furans in many samples, with concentrations varying depending on the specific facility and process stream. The highest levels were generally found in stack emissions from combustion devices used at ethylene dichloride and vinyl chloride facilities. Overall, the study estimated total emissions of dioxins and furans to the environment from these facilities to be about 12 grams per year.
Following the successful launch of its disease diagnostics laboratory facilities in Bangkok, Thailand in July 2014, Fish Vet Group Asia Ltd has now opened wet laboratory and challenge testing facilities in Chonburi, 90 minutes south-east of Bangkok.
Water system validation by- Akshay kakdeAkshay Kakde
This presentation discusses the validation of water systems used in pharmaceutical manufacturing. It covers the need for high quality water and purification systems, as well as the various qualification activities involved in validating such systems, including design qualification, installation qualification, operational qualification, and performance qualification. The presentation provides details on regulatory requirements and specifications for purified water and water for injection. It emphasizes that validation is necessary to ensure water systems consistently produce water meeting quality standards to avoid contamination of pharmaceutical products.
Cleaning validation is required by regulatory agencies to ensure equipment is cleaned properly between product batches. It provides documented evidence that cleaning procedures consistently reduce residues to acceptable limits. The objective is to verify cleaning removes product, degradation products, preservatives, and potential contaminants. Acceptance criteria include limits for detectable residues and microbial counts. Common sampling methods are swabbing, rinsing, and placebo batches to test cleaned equipment.
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
This document discusses trends in GMP issues observed in API manufacturing operations, including incomplete implementation of quality systems, narrow process validation protocols, inadequate monitoring and investigation of deviations, and other issues. Specific examples are provided of deviations occurring during drying and filtration processes where the investigations and corrective actions were determined to be insufficient. Common problems with analytical methods, reference standards, and documentation are also outlined.
1) The document describes MEDICA water purification systems for clinical diagnostics. MEDICA systems provide consistent, high quality water to ensure accurate diagnostic test results from clinical analyzers.
2) Different MEDICA systems are suited for various applications depending on required water volumes and number of analyzers. The MEDICA-R and MEDICA-D systems provide 7-15 liters/hour of water for single analyzers, while the MEDICA Pro systems can supply up to 120 liters/hour to multiple large analyzers.
3) All MEDICA systems precisely control water quality through filtration, deionization, and UV treatment to achieve bacteria levels below standards and prevent interference in diagnostic tests.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
Bs water-treatment-presentation-1-1 finalsDaphne Tan
Water treatment is crucial for safe consumption and usage. It removes contaminants like chlorine, fluoride, parasites and dioxins that can be hazardous to health. For haemodialysis patients who use large volumes of water, treatment is essential to avoid health complications. Reverse osmosis is commonly used as it removes bacteria, endotoxins and dissolved solids. Strict water quality monitoring and disinfection is needed, as contaminated water could be life threatening for haemodialysis patients. Proper equipment, storage and process design are important to ensure safe, effective water treatment.
Bs water-treatment-presentation-1-1 finalsDaphne Tan
Water treatment is important for haemodialysis patients who are exposed to large volumes of water directly through their bloodstream. Reverse osmosis (RO) is commonly used to treat water for haemodialysis as it removes contaminants, bacteria and endotoxins. Proper design, monitoring and maintenance of the RO system is required. Storage tanks must be designed to prevent bacterial growth and reject water can be recycled to reduce wastage. Regular testing is needed to ensure water quality meets Association for the Advancement of Medical Instrumentation standards to protect patient safety.
1) The document discusses validation of water systems for pharmaceutical use, including water quality specifications, purification methods, and commissioning, qualification, operation and maintenance of the systems.
2) It outlines various water grades including drinking water, purified water, highly purified water, and water for injections, and describes methods for producing each grade including distillation, ion exchange, ultrafiltration and reverse osmosis.
3) Validation of water systems aims to demonstrate the capability of the systems to consistently supply water meeting predetermined quality criteria through qualification testing over extended periods and under varying conditions.
This document discusses the need for high-quality water in pharmaceutical manufacturing. It notes that water is used directly and indirectly in products and cleaning. It then outlines the goals of understanding water quality systems, sources, and validation/qualification requirements. Various water treatment techniques are explained including filtration, softening, reverse osomosis and more. Validation involves proving the engineering design, operating procedures and maintenance plans. The presentation covers installation qualification, operational qualification, and performance qualification testing over multiple phases to verify long-term control of water systems.
The document discusses water systems and purification methods used in pharmaceutical manufacturing. It introduces different grades of water quality (e.g. purified water, water for injections) and their applications. Common water contaminants are outlined. Water purification systems may use various pretreatment steps and methods like filtration, softening, and disinfection. Proper design, operation, and maintenance of water systems is required to reliably produce water of the necessary quality.
IQ Academy Lunch & Learn Webinar | Cost Effective Water Quality Monitoring wi...IQ_UK
The document provides details of upcoming branch events for various quarrying associations in September. It also provides information on an upcoming webinar titled "Water Quality Monitoring: Making it High Quality and Cost Effective" presented by Dr. Craig Speed. The webinar will discuss how to optimize the quality of water quality monitoring programs while reducing costs to achieve cost effectiveness. It will cover monitoring design, quality control and quality assurance measures, and how to strategically reduce sampling frequency and parameters to lower expenses. A case study example is also provided.
This document provides information on water quality monitoring at the Geltec pharmaceutical manufacturing facility. It discusses the different types of water used - raw, potable, and purified water - and the critical quality parameters tested for each on a monthly basis. Methods for microbiological testing include membrane filtration for purified water and pour plating for raw and potable water. Specific microorganisms like E. coli and Pseudomonas are also tested for using various culture media. Alert and action limits are defined for parameters and appropriate corrective actions are outlined in the event of out-of-specification results.
The document discusses validation of analytical methods used in cleaning validation. It covers parameters assessed in analytical method validation like specificity, linearity, range, accuracy, precision, LOD, LOQ. It also discusses method validation, cleaning validation, levels of cleaning, cleaning process validation, typical analytical procedures and their applicability. Key aspects of validation covered include equipment and personnel qualification, microbiological considerations, documentation, sampling, rinsing, rinse samples, detergents used and establishment of acceptable limits.
This standard operating procedure describes the process for collecting surface water samples from Carter Creek on the Texas A&M University golf course. Samples will be collected using a dipper sampler and bailer sampler to obtain representative samples. After collection, samples will be tested for coliform bacteria and other water quality parameters. Proper preservation, handling, and documentation procedures will be followed to maintain sample integrity. Quality control samples like rinsates will also be collected and analyzed.
The document provides guidance on water quality sampling procedures including:
1) Laboratory preparations such as preparing sample containers, reagents, and field instruments.
2) Procedures for collecting water samples including using appropriate containers, labeling, and preservation techniques.
3) Guidance on collecting special samples like dissolved oxygen samples and how to collect and preserve composite samples.
Analytical process control bernard - 11.07.12Bosco Mbonimpa
The document discusses internal quality control (IQC) procedures for qualitative tests in a laboratory. IQC refers to the regular testing of quality control material along with patient samples, comparing the results to established statistical limits, and rejecting patient results if quality control is outside of limits. The most common laboratory error is transcription errors. Sources of error must be ruled out by repeating tests if unusual patterns are encountered. Quality control is important for blood transfusion services, rapid infectious disease tests, and all laboratory tests to monitor quality and ensure accurate results.
Principles and Instrumentation of QC Equipments by Sourav SharmaSourav Sharma
1. A conductivity meter works by applying an alternating current between two electrodes and measuring the resulting voltage. It uses this measurement to calculate conductance and then conductivity based on the cell constant.
2. Conductivity is a measure of a solution's ability to conduct an electric current and is proportional to the total dissolved ions in the solution. It is a common method used for quality control.
3. Modern conductivity cells use a 4-pole design which applies current to outer electrodes and measures voltage between inner electrodes to minimize polarization and interferences. This provides more reproducible results.
Specialty gases: essential for research, production & quality controlLinde Gas Benelux
Laboratories all around the world stand or fall by their reputation for accuracy and quality control. Pivotal to this performance is the quality, purity and composition of the spectrum of gases harnessed every day to accomplish laboratory tasks.
Rapid advancements in production processes across all industry sectors, as well as healthcare, have obliged laboratories to keep up with these changes, while remaining flexible and making allowances for future requirements. Against this background, a variety of role-specific specialised laboratory types have emerged, each addressing specific industry needs.
The document characterizes emissions of dioxins and furans from ethylene dichloride, vinyl chloride monomer and polyvinyl chloride facilities in the United States. Testing was conducted on various process streams including water, stack emissions, and products. Testing showed detectable levels of dioxins and furans in many samples, with concentrations varying depending on the specific facility and process stream. The highest levels were generally found in stack emissions from combustion devices used at ethylene dichloride and vinyl chloride facilities. Overall, the study estimated total emissions of dioxins and furans to the environment from these facilities to be about 12 grams per year.
Following the successful launch of its disease diagnostics laboratory facilities in Bangkok, Thailand in July 2014, Fish Vet Group Asia Ltd has now opened wet laboratory and challenge testing facilities in Chonburi, 90 minutes south-east of Bangkok.
Water system validation by- Akshay kakdeAkshay Kakde
This presentation discusses the validation of water systems used in pharmaceutical manufacturing. It covers the need for high quality water and purification systems, as well as the various qualification activities involved in validating such systems, including design qualification, installation qualification, operational qualification, and performance qualification. The presentation provides details on regulatory requirements and specifications for purified water and water for injection. It emphasizes that validation is necessary to ensure water systems consistently produce water meeting quality standards to avoid contamination of pharmaceutical products.
Cleaning validation is required by regulatory agencies to ensure equipment is cleaned properly between product batches. It provides documented evidence that cleaning procedures consistently reduce residues to acceptable limits. The objective is to verify cleaning removes product, degradation products, preservatives, and potential contaminants. Acceptance criteria include limits for detectable residues and microbial counts. Common sampling methods are swabbing, rinsing, and placebo batches to test cleaned equipment.
Bioburden control: Strategies to address bioburden control in downstream proc...Merck Life Sciences
Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
In this webinar, you will learn:
• Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies.
• Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists.
• Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Register for our webinar here: https://bit.ly/3c4q9rr
This document discusses trends in GMP issues observed in API manufacturing operations, including incomplete implementation of quality systems, narrow process validation protocols, inadequate monitoring and investigation of deviations, and other issues. Specific examples are provided of deviations occurring during drying and filtration processes where the investigations and corrective actions were determined to be insufficient. Common problems with analytical methods, reference standards, and documentation are also outlined.
1) The document describes MEDICA water purification systems for clinical diagnostics. MEDICA systems provide consistent, high quality water to ensure accurate diagnostic test results from clinical analyzers.
2) Different MEDICA systems are suited for various applications depending on required water volumes and number of analyzers. The MEDICA-R and MEDICA-D systems provide 7-15 liters/hour of water for single analyzers, while the MEDICA Pro systems can supply up to 120 liters/hour to multiple large analyzers.
3) All MEDICA systems precisely control water quality through filtration, deionization, and UV treatment to achieve bacteria levels below standards and prevent interference in diagnostic tests.
Validation of pharaceutical water system and pure steamJp Prakash
This document discusses the validation of pharmaceutical water systems and pure steam. It covers the validation sequences of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification involves validating components like piping, tanks, filters, and distillation stills. Installation qualification ensures proper installation. Performance qualification demonstrates the system can reliably produce water and steam meeting quality requirements over extended use. Validation is necessary to assure safety, efficacy and quality according to regulations.
Bs water-treatment-presentation-1-1 finalsDaphne Tan
Water treatment is crucial for safe consumption and usage. It removes contaminants like chlorine, fluoride, parasites and dioxins that can be hazardous to health. For haemodialysis patients who use large volumes of water, treatment is essential to avoid health complications. Reverse osmosis is commonly used as it removes bacteria, endotoxins and dissolved solids. Strict water quality monitoring and disinfection is needed, as contaminated water could be life threatening for haemodialysis patients. Proper equipment, storage and process design are important to ensure safe, effective water treatment.
Bs water-treatment-presentation-1-1 finalsDaphne Tan
Water treatment is important for haemodialysis patients who are exposed to large volumes of water directly through their bloodstream. Reverse osmosis (RO) is commonly used to treat water for haemodialysis as it removes contaminants, bacteria and endotoxins. Proper design, monitoring and maintenance of the RO system is required. Storage tanks must be designed to prevent bacterial growth and reject water can be recycled to reduce wastage. Regular testing is needed to ensure water quality meets Association for the Advancement of Medical Instrumentation standards to protect patient safety.
1) The document discusses validation of water systems for pharmaceutical use, including water quality specifications, purification methods, and commissioning, qualification, operation and maintenance of the systems.
2) It outlines various water grades including drinking water, purified water, highly purified water, and water for injections, and describes methods for producing each grade including distillation, ion exchange, ultrafiltration and reverse osmosis.
3) Validation of water systems aims to demonstrate the capability of the systems to consistently supply water meeting predetermined quality criteria through qualification testing over extended periods and under varying conditions.
There is a need to screen for an ever increasing number of chemically diverse contaminants that maybe present in the environment. Typically these contaminants may only be present at very low (ppb or even ppt) concentrations and due to the the complexity of the sample matrices encountered this screening is an increasingly demanding analytical challenge.
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the need to validate water systems due to water being the most commonly used raw material. The validation process includes design qualification, installation qualification, operation qualification and performance qualification to ensure appropriate design, installation, and operation of the system. Regular monitoring and maintenance is also required to guarantee continued production of water meeting quality specifications.
The document discusses the validation of a water supply system for a pharmacy college. It outlines the objectives of validation to ensure consistent production of water meeting quality specifications. The validation process includes design qualification, installation qualification, operation qualification, and performance qualification to test the system under all expected operating conditions. Key steps involve defining quality attributes, developing a validation protocol and acceptance criteria, conducting testing and data collection, and documenting the validation results.
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the need to validate water systems due to water being the most commonly used raw material. The validation process includes design qualification, installation qualification, operation qualification and performance qualification to ensure appropriate design, installation, and operation of the system. Regular monitoring and maintenance is also required to guarantee continued production of water meeting quality specifications.
The document discusses the validation of water supply systems for pharmaceutical use. It outlines the validation process, which includes design qualification to verify the system design, installation qualification to confirm proper installation, operation qualification to test system functionality under static conditions, and performance qualification to demonstrate consistent performance over time under normal operating conditions. Routine monitoring, maintenance, and change control procedures are also required to ensure continued system operation and water quality as specified.
While the public considers municipal water to be “pure”, the pharmaceutical market considers municipal water (feedwater) just the starting point in producing pure water. Water is the most widely used excipient in pharmaceutical manufacturing, and pharmaceutical water is a multi-functional resource, crossing all disciplines in the pharmaceutical industry. Water is used as a raw material, solvent, ingredient, reagent, and clean-ing agent, and is produced in a variety of “pure” forms.
Assessment and surveillance of drinking water qualityjyotinayak44
The WHO published guidelines for drinking water quality to ensure the safety of drinking water supplies. The guidelines relate to acceptability, microbiological, chemical, and radiological aspects of water quality. Key water quality parameters discussed in the document include turbidity, color, pH, chloride, calcium, ammonia, iron, sodium, and bacterial indicators like coliforms and E. coli. Guidelines are provided for acceptable levels of various chemical and radiological constituents in drinking water. Continuous monitoring of water quality is needed to assess safety and protect public health.
Water quality laboratories and different water quality testing فہیمہ کاسی
This document discusses water quality laboratories and different types of water quality testing. It describes three levels of water quality laboratories - basic, intermediate, and advanced - which differ in location, staffing, equipment, and testing capabilities. The document also outlines various water quality tests, including physical, chemical, and microbiological tests. Physical tests measure properties like turbidity, pH, and electrical conductivity. Chemical tests analyze parameters such as chlorides, sulfates, and bicarbonates. Microbiological tests qualitatively and quantitatively analyze microbes like coliform bacteria.
This document discusses quality assurance in haematology. It defines quality and introduces the concepts of quality control and quality assurance. Quality control aims to minimize errors through statistical sampling and verification of consistent performance. Quality assurance ensures reliable test results through adherence to standards within and outside the laboratory. This includes internal quality control, external quality assessment, and standardization using reference materials and methods. Several examples are provided of potential pre-analytical errors in sample collection, transport, and handling that can affect test results. Adherence to proper procedures is emphasized to avoid issues like hemolysis, clotting, and dilution.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Validation of water systems used to produce demineralized, distilled, and water for injection is important in the pharmaceutical industry to ensure water quality. The document discusses the objectives, types, design, operation, and monitoring of water systems. Key aspects of validation include design qualification, installation qualification, operational qualification, and performance qualification to demonstrate systems consistently produce water meeting quality specifications under all operating conditions. Ongoing maintenance and revalidation if changes are made helps maintain system performance over time.
This document provides an operations manual for water quality analysis laboratories. It outlines good laboratory practices and standard analytical procedures that should be followed to ensure quality assurance and obtain reliable results. This includes guidelines for chemical handling, glassware cleaning, distilled water quality, weighing measurements, record keeping, equipment maintenance, sample collection/preservation, laboratory safety, and analytical quality control. Standard procedures are then provided for over 40 common water quality parameters. Results are to include the method of analysis, analytical quality control measures, number of significant digits, and any warning levels. All data must be properly recorded and validated.
This document provides an operations manual for water quality analysis. It discusses good laboratory practices and quality assurance protocols that should be followed, including proper handling of chemicals, cleaning of glassware, measurement techniques, and maintenance of laboratory equipment. Standard analytical procedures for over 30 water quality parameters are also described. The manual establishes guidelines for sample receipt, storage, analysis, and reporting results to ensure reliable and comparable water quality data.
This document provides an operations manual for water quality analysis laboratories. It discusses good laboratory practices and quality assurance protocols that should be followed, including procedures for sample handling, analytical methods, equipment maintenance, and data recording. Standard analytical methods are described for over 40 water quality parameters. Laboratories are expected to adhere to proper chemical and equipment handling techniques, quality control measures, and documentation practices to ensure reliable and comparable analytical results.
Thornton recently published a helpful guide for best practices in pure water measurement. It is entitled "Compliance by Design in Pharmaceutical Water Systems". The document provides an summary of water sources and contaminants, then continues with an outline of industry requirements for bulk waters. The production of pure water is dicussed, and recommendations for pharmaceutical water system instrumentation are provided.
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This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
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8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Ageing, the Elderly, Gerontology and Public Health
Calidad del agua en el laboratorio
1. 1
Water in the Clinical Laboratory
Mikael Cleverstam
WW Clinical Business Manager
Role of water in Clinical Diagnostic
Purification technologies basics
Delivering water to the clinical analyzer
2. 2
Putting it all together
PatientPatient
ResultsResults
WaterWater
QualityQuality
DiagnosticDiagnostic
InstrumentsInstruments
MedicalMedical
TechnologistTechnologist
Quality ControlQuality Control
Diagnostic instruments
Assay developmentPatient results
Troubleshooting Your analyzer
Water quality as part
of the quality process
CLSI New standards
Water purification
Quality system
3. 3
Normal seen Problems
Frequent Calibrations
High CV%
Fluctuation in quality results over the day/week/month
Interfered assays
Calcium Interfered by rocks, leaves, geology
ALP Interfered by biofilm, detergent, rocks
CK Interfered by water treatment
Amylase Interfered by citrus fruit, detergents, leaves
LD Interfered by effluent, leaves, H2O2
Phosphorus Interfered by citrus fruit, leaves
Iron Interfered by rocks, leaves, detergents
Magnesium Interfered by citrus fruit
Triglycerides Interfered by plastics, chemicals
Urea Interfered by citrus fruit, water treatment
Troponin I Interfered by biofilm
4. 4
Water for Clinical Analysers
Cuvette washing
Tubing and probe rinsing
Reagent and buffer reconstitution
Dilution
Water Baths
5. 5
Clinical Analyzers
Features and benefits of automation
Precision optical systems for accuracy in testing
Automatic sampling and dilutions modes
Real time alerts to patient and QC failures
Improved software alerts end user to mechanical failures
Cost benefits
Workflow efficiency and high speed through put
Instrumentation targeted to reduce operating cost with more
efficient technology
Reduced operator interface
DiagnosticDiagnostic
InstrumentsInstruments
6. 6
Assay Development
Measuring chemical changes in the body for diagnosis, therapy and
prognosis has resulted in new assay development
Multiple method testing on a single analyzer
Current research methodologies for infectious disease and tumor
marker’s are moving from research labs in universities to the clinical
laboratory
Complex methodologies are being fully automated for more routine use
DiagnosticDiagnostic
InstrumentsInstruments
7. 7
Unique Challenges for Medical Technologist
Verification of final clinical results to be accurate and precise are
determined by Medical Technologist
Clinical decisions are not solely made on the test result, but in
conjunction with the patient’s history and symptoms
Software alerts, QC reviews, calibration must all be within stated limits
before results are released
Troubleshooting instrument problems result in production delays, are
costly and non-productive activities that must be performed and
documented
➙ Try to avoid diagnostic instrument service because it is expensive
MedicalMedical
TechnologistTechnologist
8. 8
Reviewing Patient Results
All analytical and pre-analytical factors must be reviewed and
documented
Medical Technologist must review all test results
If results are flagged, troubleshooting the cause is necessary
MedicalMedical
TechnologistTechnologist
PatientPatient
ResultsResults
Quality ControlQuality Control
DiagnosticDiagnostic
InstrumentsInstruments
9. 9
Troubleshooting procedures
Sample handling procedures confirmed
Quality control must be reviewed
Shifts and trends
Peer group
Previous data
Assay
Reagent issue
Calibrator stability
Mechanical
Instrument malfunction
Error codes
If above solutions do not correct the erroneous result, further
troubleshooting must identify cause before results can be released to
physicians
➙ Delayed patient treatment.
MedicalMedical
TechnologistTechnologist
PatientPatient
ResultsResults
Quality ControlQuality Control
DiagnosticDiagnostic
InstrumentsInstruments
11. 11
Water Quality
Quality results are dependent upon reliable instrumentation and
known water quality
Analytical factors need to be controlled and optimized to reduce the
number of test failures, failed calibrations, and high blanks that can
contribute to erroneous patient results
Maintenance of high purity water system is essential to reliable results
WaterWater
QualityQuality
12. 12
Understanding Water Quality
and Methodology
Water should be considered a bulk reagent on any analyzer
The high purity water system is a separate unit, not monitored by
diagnostic software on the clinical analyzer
The unique properties of water if not processed and monitored can
produce subtle changes in assay methods
These changes in water quality can lead to erratic and inconsistent
results
The quality of water required or its impact on the testing method
is often not considered until the purchase is complete
WaterWater
QualityQuality
13. 13
Diagnostic Dilemma
Smaller sample size and reaction vessel are subjected
to harsher environment
Inevitable build-up of biofilm in instruments, manifolds and tubing
require more frequent decontaminations
but
Less and less time available for maintenance of the instruments
Some sensitive assays can become contaminated with bacteria and
ions
Bacteria release enzymes and ions whose behavior is similar to the
enzymes targeted in the assay method
➙ Increased need to monitor water quality as closely as any other
instrument malfunction
DiagnosticDiagnostic
InstrumentsInstruments
WaterWater
QualityQuality
15. 15
Demonstration of ALP release from bacteria
Correlation between bacteria concentrations and levels of ALP
in water
Bacteria Strain
(identification by 16S rDNA sequencing)
Bacteria level
(x 106
cfu/mL)
ALP concentration
(µUnit/µL)
Sphingomonas paucimobilis
Caulobacter crescentus
Ralstonia pickettii
29.2
9.7
29.5
6.22
9.95
8.29
DiagnosticDiagnostic
InstrumentsInstruments
WaterWater
QualityQuality
17. 17
CLSI Water Quality Standards
New Standards released July 2006 (C3-A4 Vol. 26 No. 22)
Nomenclature Type I,II,III has been replaced with purity types that
provide more meaningful parameters
CLRW (Clinical Laboratory reagent Water) replaces Type I,II for most applications
IFW (Instrument Feed Water) allows instrument manufacturers to clarify specifications
for their particular methods
SRW ( Special Reagent Water) may be specified for specific applications when
additional parameter are needed to insure water quality
Autoclave and wash water will meet the requirements of previously classified Type III
Complete review of the document should be done when considering
new applications to insure the contaminants found in the source water
do not become an issue
WaterWater
QualityQuality
Quality ControlQuality Control
18. 18
Water Contaminants
Water: H2O …. and some other things
Purification technologies
H
H
H
H
Presence of contaminants
Particles
Gases
Microorganisms
Ions
Organics
19. 19
Protecting the Water Purification Unit:
Pretreatment cartridge
Due to the difference in water
quality around the world, additional
pretreatment cartridges are
required.
The cartridges provide protection
and insure good performance of the
reverse osmosis membrane
The pretreatment packs include 0. 5
micron filter (1) to remove particles
and activated carbon (2) to remove
chlorine
The activated carbon is
impregnated with a small level of
silver to prevent bacterial growth.
Example of a
pretreatment cartridge
21. 21
Technology Insight: Electro-Deionization
Resistivity: > 10 MΩ.cm
TOC: < 30 ppb
No need for regeneration
A - Anionic Membrane
C - Cationic Membrane
A C A C
CathodeCathode
Na+
Na+
H+
H+
OH-
Cl-
Na+
ProductProduct
+ Cl-
Cl-
Cl-
Cl-
Reverse Osmosis WaterReverse Osmosis Water
10 - 2010 - 20 µµS/cmS/cm
Na+
-AnodAnod
ee
RejectReject
Na+
OH-
EDI module
- Ion selective membranes
- Ion exchange resins
- Continuous current
22. 22
Filters – Bacteria Removal
Screen 0.2 µm filters
Designed for the removal of particles and microorganisms from
liquids and gases.
Use of PVDF membranes, provide high flow rates and
throughputs, low extractables, broad chemical compatibility and
the lowest protein binding of any membrane available.
23. 23
Ultrafiltration
Cut-off: 5 KDa to 20 KDa
Removes bacterial by-products such as most proteins and
macromolecules (e.g. endotoxins)
Utilized for immunochemistry assays
Immunoenzyme assays based on reporter enzymes (alkaline
phosphatase, ALP) are sensitive to ALP released by bacteria
Also filters bacteria
24. 24
Storage
CLRW water with a resistivity >10 megohm-cm cannot be stored
because ionic and organic contamination will leach from the
atmosphere and container materials in which it is stored.
CLRW water should be used as it is produced
Stored water is never as pure as when it is made
Storage of water enhances bacterial contamination
Containers need to be cleaned thoroughly between refilling.
Carboys, tanks, bottles
Notorious source of contamination since we often refill them without
thoroughly cleaning them when they are emptied
Some plastic materials out-gas polymers and plasticizers, and
these end up in the water
25. 25
Water Purification Unit
Feed
water
To analyzer
Pretreatment
cartridge
Pump
Reverse Osmosis
cartridge
Electrodeionization
module
Drain
UV
Germicidal
Ion exchange
resins
Tank
Simplified flow schematic combining purification technologies
The electrodeionization module is not present in some purification units
Resistivity
cell
26. 26
Connecting the Water Purification Unit to the
Clinical Analyzer
Water is delivered in its purified state to a harsh environment
within the chemistry analyzer bottle
Water bottles inside analyzer are not frequently decontaminated
Electronics, mechanical hardware, pumps all create heat within the
analyzer cabinet, thus raising the interior temperature of the water
bottle.
Increased temperatures enhance the growth of bacteria and biofilm
within the instruments manifolds and tubings.
A biofilm is an agglomeration of particulates, organic substances and bacteria on the inner surface of the reservoir.
As indicated earlier, bacteria do not “like” to grow alone, in the middle of water . They rather tend to stick to a support . This is what happens ususally inside reservoirs : some partciulates and organic substances bind to the surface; bacteria attach themselves to the same point, and a biofilm grows and becomes thicker with time, releasing from time to time bacteria in the stored water.
NB : just to give an order of magnitude about what represents 1 cfu/ml. For a simple calculation, let’s consider that a bacteria occupies 0.1 um 3 (it usually occupies a smaller volume : Pseudomonas Diminuta volume is about 0.01 um3- this is just to make the demonstration easier).A 0.1 um3 volume corresponds to 0.1 x (10*-6m)3 = 10*-19 m3. Therefore, the volume occupied by 1 billion bacteria would be 10*-19 x 10*9 = 10*-10 m3 = 10*-7L = 10*-4 ml= 0.0001 ml . This means that 1ppb (1 part per billion ) bacteria corresponds to 1 bacteria per 0.0001 ml , or 10,000 bacteria per ml.