This document discusses the implementation of revisions to the STI document STI/13849/4 due to the publication of Amendment No. 5 to the Indian Standard IS 13849:1993 for portable fire extinguishers of the dry powder type. Key points include:
1. Amendment No. 5 deletes the fire knock down test and includes a test for adhesion of plastic lining.
2. The revised STI document must be implemented by August 1, 2005.
3. Applications already in an advanced stage can be processed under the previous standard if the applicant agrees to implement the revised STI by August 1.
The document discusses process validation for pharmaceutical manufacturing. It defines process validation and describes the objectives of validating manufacturing processes to consistently produce drugs that meet quality standards. The document outlines the types of process validation, including prospective, concurrent, retrospective, and revalidation. It also discusses selecting and evaluating industrial processes for tablet production, in-process testing, annual product reviews, and references.
This document provides the national standard of the People's Republic of China for pressure vessels - Part 4: Fabrication, inspection and testing, and acceptance. It replaces some sections of the 1998 standard and includes additional requirements. The document outlines the scope, references, terms, general provisions, material testing and segmentation requirements, fabrication processes, welding, heat treatment, testing, and acceptance criteria for pressure vessels. It aims to standardize the manufacturing, inspection, and acceptance of pressure vessels in China.
This document summarizes a seminar presentation on validation of equipment. It discusses the objectives and main parts of the validation process, including installation qualification, operational qualification and performance qualification. It provides an example of validating a dissolution test apparatus, describing specific tests run during installation qualification and operational qualification. Finally, it mentions that process analytical technology will add new dimensions to equipment validation in the future.
The document discusses various aspects of process validation for pharmaceutical products. It defines process validation as a documented program that provides a high degree of assurance a specific process will consistently produce a product meeting its predetermined specifications. It outlines the key stages of process validation including process design, process qualification, and continued process verification. The document also discusses validation of different dosage forms including solids, liquids, semisolids, and parenterals. It covers validation of various processes involved such as mixing, granulation, filling, and inspection. Validation of equipment and facilities is also summarized.
The document discusses the importance of batch manufacturing records (BMRs) in pharmaceutical manufacturing. It states that BMRs should document every step of the manufacturing process for a particular batch, including equipment used, materials added, process parameters, samples taken, and test results. They help trace the complete manufacturing cycle and ensure consistency between batches. The document outlines the responsibilities of production, quality assurance, and quality control in preparing, reviewing, and approving BMRs to ensure compliance with GMP standards.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
Validation is the process of checking of the process, equipment and method whereas qualification is solely done for equipment and qualification of instrument helps in quality of pharmaceutical product.
The document discusses process validation for pharmaceutical manufacturing. It defines process validation and describes the objectives of validating manufacturing processes to consistently produce drugs that meet quality standards. The document outlines the types of process validation, including prospective, concurrent, retrospective, and revalidation. It also discusses selecting and evaluating industrial processes for tablet production, in-process testing, annual product reviews, and references.
This document provides the national standard of the People's Republic of China for pressure vessels - Part 4: Fabrication, inspection and testing, and acceptance. It replaces some sections of the 1998 standard and includes additional requirements. The document outlines the scope, references, terms, general provisions, material testing and segmentation requirements, fabrication processes, welding, heat treatment, testing, and acceptance criteria for pressure vessels. It aims to standardize the manufacturing, inspection, and acceptance of pressure vessels in China.
This document summarizes a seminar presentation on validation of equipment. It discusses the objectives and main parts of the validation process, including installation qualification, operational qualification and performance qualification. It provides an example of validating a dissolution test apparatus, describing specific tests run during installation qualification and operational qualification. Finally, it mentions that process analytical technology will add new dimensions to equipment validation in the future.
The document discusses various aspects of process validation for pharmaceutical products. It defines process validation as a documented program that provides a high degree of assurance a specific process will consistently produce a product meeting its predetermined specifications. It outlines the key stages of process validation including process design, process qualification, and continued process verification. The document also discusses validation of different dosage forms including solids, liquids, semisolids, and parenterals. It covers validation of various processes involved such as mixing, granulation, filling, and inspection. Validation of equipment and facilities is also summarized.
The document discusses the importance of batch manufacturing records (BMRs) in pharmaceutical manufacturing. It states that BMRs should document every step of the manufacturing process for a particular batch, including equipment used, materials added, process parameters, samples taken, and test results. They help trace the complete manufacturing cycle and ensure consistency between batches. The document outlines the responsibilities of production, quality assurance, and quality control in preparing, reviewing, and approving BMRs to ensure compliance with GMP standards.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
Validation is the process of checking of the process, equipment and method whereas qualification is solely done for equipment and qualification of instrument helps in quality of pharmaceutical product.
Overview of third party testing children's products, including initial certification testing, material change testing, component part testing, and periodic testing. Discussion of recordkeeping requirements and undue influence training requirements.
Qualification of laboratory equipments by Mayuri SoniMayuri Soni
The document provides standard operating procedures (SOPs) for qualifying common laboratory equipment used for quality control testing of pharmaceuticals. It describes calibration procedures for hardness testers, friability test apparatus, tap density apparatus, disintegration testers, and dissolution test apparatus. The SOPs outline how to test that the equipment meets specifications for factors like force measurements, rotation speeds, temperature control, and oscillations. Regular calibration is necessary to confirm equipment is functioning properly and producing accurate results.
This document outlines the procedure for performing positive material identification (PMI) using x-ray fluorescence spectroscopy (XRF). It describes the purpose, scope, references, definitions, training, safety, equipment, and procedure for PMI testing. The procedure involves surface preparation of test items, equipment calibration checks, reading frequency, identification and marking of verified materials, verification criteria, and reporting of test results. PMI is used to determine the chemical composition of metallic materials without removing samples.
The document discusses validation which is a process used to prove that manufacturing processes will consistently produce products meeting quality standards. It defines validation, describes related terms like qualification, and explains the various phases of qualification including design qualification, installation qualification, operational qualification, performance qualification, and requalification. The goals and key considerations of each qualification phase are outlined to establish that equipment is properly designed, installed, operated, and performs as intended.
The document discusses validation and qualification processes for equipment. It defines validation as establishing scientific evidence that a process is capable of consistently delivering quality products. Qualification is considered a subset of validation and ensures equipment is installed and will perform as intended. The key stages of validation are discussed as process design, process qualification, and continued process verification. Qualification includes design qualification, installation qualification, operational qualification, and performance qualification to demonstrate equipment is suitable for its intended use.
Steam sterilization uses high-pressure steam to kill microorganisms. It is the most effective sterilization method when heat and moisture do not damage products. An autoclave uses steam to heat items inside a pressurized chamber, reaching temperatures over 121°C. Validation of a sterilization process involves qualification of the autoclave design, installation, operation, and performance through studies measuring temperature distribution, heat penetration, and using biological indicators to confirm a sterilization log reduction factor is achieved.
Process validation and validation requirementRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
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.
QUALIFICATION OF TAP DENSITY TESTER & DISINTEGRATION TESTERUshaKhanal3
The document discusses the qualification requirements for a tapped density tester and disintegration tester used in pharmaceutical validation. It outlines the user requirements, design qualification, installation qualification, operational qualification, and performance qualification that must be completed to ensure the equipment is properly installed and operating as intended according to specifications. Key steps include verifying the equipment dimensions and operating conditions, testing that the tapped density tester can accurately measure density and the disintegration tester can oscillate tablets at the appropriate speed and temperature.
This document discusses the qualification of equipment used in the production of artemisinin-based combined medicines. It covers the objectives, principles, and stages of equipment qualification, including design qualification, installation qualification, operational qualification, and performance qualification. The stages of qualification ensure that equipment is suitable for its intended uses and capable of consistently meeting specifications. Qualification applies to all production and quality control equipment and must demonstrate acceptable performance under worst-case conditions. Periodic requalification is necessary to confirm continued suitability of equipment for its uses.
Ultra-HPHT perforating system opens access to untapped reservoirs Baker Hughes
By Charlie McClean, Bill Myers, Didhiti
Talapatra, Mark Sloan and Stephen
Zuklic, Baker Hughes
Originally appeared in World Oil® SEPTEMBER 2014 issue, pgs 45-49. Posted with permission.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
Validation of Heat ventilation air conditioningPrashant Tomar
This document discusses the user requirement specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of heating, ventilation, and air conditioning (HVAC) systems used in pharmaceutical plants. The HVAC system must be qualified to ensure it is designed and installed properly and works as expected. The URS define the room temperature, humidity, and air cleanliness requirements. The DQ confirms the design meets the URS. The IQ verifies correct installation. The OQ tests the system operation. Finally, the PQ assesses the HVAC performance under normal operating conditions.
The document discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
Punjab weights and measures (international system) enforcement rules, 1976.docCitynet Netcafe
This document outlines rules related to weights and measures enforcement in Punjab, Pakistan. It covers:
1. Definitions of key terms like secondary standards, working standards, commercial weights and measures.
2. Requirements and specifications for various weights and measures like secondary standards, working standards, commercial weights, and instruments.
3. Procedures for inspection, verification, stamping and fees for weights and measures used in trade and commerce.
4. Reporting responsibilities of Inspectors and penalties for unauthorized weights and measures.
The rules establish the standards and oversight process to ensure accurate weights and measures are used in commercial transactions in Punjab.
Guidance for industry cmc postapproval manufacturing changes to be documented...Samir Barragán
This guidance from the FDA provides recommendations to drug application holders regarding CMC post-approval manufacturing changes that should be documented in annual reports rather than submitted as supplements. It includes appendices listing examples of changes that generally have a minimal potential effect on product quality, such as equipment additions or minor manufacturing process changes. The guidance aims to clarify reporting requirements, better allocate FDA resources, and implement a risk-based approach to CMC regulation as recommended in the FDA's Pharmaceutical Quality Initiative.
This document discusses the validation of dissolution test apparatus. It begins with a brief history of validation and reasons for validating equipment. Validation ensures equipment operates consistently and accurately. The document then discusses various types of dissolution test apparatus and the qualification process, including design, installation, operational, and performance qualification. It also addresses sources of error and concludes that acceptable qualification demonstrates the apparatus is validated for use in dissolution testing.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document provides recommendations for the standard operating procedure for preparing calibration certificates. Calibration certificates should contain specific essential information, including: the title, laboratory information, unique identification, client information, test methods used, item description and identification, dates, test results, signatures, and statements regarding the applicability and reproducibility of the results. Proper documentation ensures calibration certificates accurately convey test information and can be properly used and referenced. Sample calibration certificates and checklists are provided as examples to ensure certificates meet these guidelines.
The document discusses the qualification of analytical equipment, specifically gas chromatography. It describes the four parts of qualification: design qualification, installation qualification, operational qualification, and performance qualification. It then provides examples of tests and acceptance criteria for various parameters of a gas chromatography system, including the inlet system, oven, and flame ionization detector. Tests include leak tests, repeatability, linearity, noise, drift and more. The goal is to verify that the GC system is installed and functioning properly.
Overview of third party testing children's products, including initial certification testing, material change testing, component part testing, and periodic testing. Discussion of recordkeeping requirements and undue influence training requirements.
Qualification of laboratory equipments by Mayuri SoniMayuri Soni
The document provides standard operating procedures (SOPs) for qualifying common laboratory equipment used for quality control testing of pharmaceuticals. It describes calibration procedures for hardness testers, friability test apparatus, tap density apparatus, disintegration testers, and dissolution test apparatus. The SOPs outline how to test that the equipment meets specifications for factors like force measurements, rotation speeds, temperature control, and oscillations. Regular calibration is necessary to confirm equipment is functioning properly and producing accurate results.
This document outlines the procedure for performing positive material identification (PMI) using x-ray fluorescence spectroscopy (XRF). It describes the purpose, scope, references, definitions, training, safety, equipment, and procedure for PMI testing. The procedure involves surface preparation of test items, equipment calibration checks, reading frequency, identification and marking of verified materials, verification criteria, and reporting of test results. PMI is used to determine the chemical composition of metallic materials without removing samples.
The document discusses validation which is a process used to prove that manufacturing processes will consistently produce products meeting quality standards. It defines validation, describes related terms like qualification, and explains the various phases of qualification including design qualification, installation qualification, operational qualification, performance qualification, and requalification. The goals and key considerations of each qualification phase are outlined to establish that equipment is properly designed, installed, operated, and performs as intended.
The document discusses validation and qualification processes for equipment. It defines validation as establishing scientific evidence that a process is capable of consistently delivering quality products. Qualification is considered a subset of validation and ensures equipment is installed and will perform as intended. The key stages of validation are discussed as process design, process qualification, and continued process verification. Qualification includes design qualification, installation qualification, operational qualification, and performance qualification to demonstrate equipment is suitable for its intended use.
Steam sterilization uses high-pressure steam to kill microorganisms. It is the most effective sterilization method when heat and moisture do not damage products. An autoclave uses steam to heat items inside a pressurized chamber, reaching temperatures over 121°C. Validation of a sterilization process involves qualification of the autoclave design, installation, operation, and performance through studies measuring temperature distribution, heat penetration, and using biological indicators to confirm a sterilization log reduction factor is achieved.
Process validation and validation requirementRavish Yadav
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document provides a qualification protocol for bag sealing equipment. It outlines responsibilities for authoring, executing, reviewing, and approving qualification tests. The protocol scope is to establish evidence that the bag sealer is properly installed and operating according to requirements. It describes the bag sealer, lists test plans to verify installation and operation, and defines acceptance criteria. Responsibilities for personnel involved in authoring, executing, reviewing and approving the qualification tests are also defined.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
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.
QUALIFICATION OF TAP DENSITY TESTER & DISINTEGRATION TESTERUshaKhanal3
The document discusses the qualification requirements for a tapped density tester and disintegration tester used in pharmaceutical validation. It outlines the user requirements, design qualification, installation qualification, operational qualification, and performance qualification that must be completed to ensure the equipment is properly installed and operating as intended according to specifications. Key steps include verifying the equipment dimensions and operating conditions, testing that the tapped density tester can accurately measure density and the disintegration tester can oscillate tablets at the appropriate speed and temperature.
This document discusses the qualification of equipment used in the production of artemisinin-based combined medicines. It covers the objectives, principles, and stages of equipment qualification, including design qualification, installation qualification, operational qualification, and performance qualification. The stages of qualification ensure that equipment is suitable for its intended uses and capable of consistently meeting specifications. Qualification applies to all production and quality control equipment and must demonstrate acceptable performance under worst-case conditions. Periodic requalification is necessary to confirm continued suitability of equipment for its uses.
Ultra-HPHT perforating system opens access to untapped reservoirs Baker Hughes
By Charlie McClean, Bill Myers, Didhiti
Talapatra, Mark Sloan and Stephen
Zuklic, Baker Hughes
Originally appeared in World Oil® SEPTEMBER 2014 issue, pgs 45-49. Posted with permission.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
Validation of Heat ventilation air conditioningPrashant Tomar
This document discusses the user requirement specifications (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of heating, ventilation, and air conditioning (HVAC) systems used in pharmaceutical plants. The HVAC system must be qualified to ensure it is designed and installed properly and works as expected. The URS define the room temperature, humidity, and air cleanliness requirements. The DQ confirms the design meets the URS. The IQ verifies correct installation. The OQ tests the system operation. Finally, the PQ assesses the HVAC performance under normal operating conditions.
The document discusses principles and approaches to cleaning validation for pharmaceutical manufacturing. It covers topics such as cleaning validation protocols and reports, personnel and equipment, use of detergents, microbiology, sampling, analytical methods, acceptable limits, and bracketing of products for validation. The objectives of cleaning validation are to demonstrate that cleaning procedures adequately remove product, detergent, and microbial residues to prevent contamination and cross-contamination. Written standard operating procedures and documentation of validation studies are required.
Punjab weights and measures (international system) enforcement rules, 1976.docCitynet Netcafe
This document outlines rules related to weights and measures enforcement in Punjab, Pakistan. It covers:
1. Definitions of key terms like secondary standards, working standards, commercial weights and measures.
2. Requirements and specifications for various weights and measures like secondary standards, working standards, commercial weights, and instruments.
3. Procedures for inspection, verification, stamping and fees for weights and measures used in trade and commerce.
4. Reporting responsibilities of Inspectors and penalties for unauthorized weights and measures.
The rules establish the standards and oversight process to ensure accurate weights and measures are used in commercial transactions in Punjab.
Guidance for industry cmc postapproval manufacturing changes to be documented...Samir Barragán
This guidance from the FDA provides recommendations to drug application holders regarding CMC post-approval manufacturing changes that should be documented in annual reports rather than submitted as supplements. It includes appendices listing examples of changes that generally have a minimal potential effect on product quality, such as equipment additions or minor manufacturing process changes. The guidance aims to clarify reporting requirements, better allocate FDA resources, and implement a risk-based approach to CMC regulation as recommended in the FDA's Pharmaceutical Quality Initiative.
This document discusses the validation of dissolution test apparatus. It begins with a brief history of validation and reasons for validating equipment. Validation ensures equipment operates consistently and accurately. The document then discusses various types of dissolution test apparatus and the qualification process, including design, installation, operational, and performance qualification. It also addresses sources of error and concludes that acceptable qualification demonstrates the apparatus is validated for use in dissolution testing.
The document discusses the validation of liquid oral dosage forms. It defines validation as providing a high degree of assurance that a specific manufacturing process will consistently produce a product meeting predetermined specifications. The validation of liquids includes qualifying equipment and facilities. Critical process parameters for manufacturing oral solutions, suspensions, and emulsions include mixing speed and time, homogenization speed and time, and filtration. Acceptance criteria include product clarity, viscosity, pH, assay, sedimentation volume, resuspension, and particle size. At least three successful validation batches are typically required to validate a new product or process.
This document provides recommendations for the standard operating procedure for preparing calibration certificates. Calibration certificates should contain specific essential information, including: the title, laboratory information, unique identification, client information, test methods used, item description and identification, dates, test results, signatures, and statements regarding the applicability and reproducibility of the results. Proper documentation ensures calibration certificates accurately convey test information and can be properly used and referenced. Sample calibration certificates and checklists are provided as examples to ensure certificates meet these guidelines.
The document discusses the qualification of analytical equipment, specifically gas chromatography. It describes the four parts of qualification: design qualification, installation qualification, operational qualification, and performance qualification. It then provides examples of tests and acceptance criteria for various parameters of a gas chromatography system, including the inlet system, oven, and flame ionization detector. Tests include leak tests, repeatability, linearity, noise, drift and more. The goal is to verify that the GC system is installed and functioning properly.
How to view the material certificate part 1Mohamed Farouk
The document discusses material certification according to EN 10204 standards. It explains that EN 10204 specifies different types of inspection documents provided by manufacturers, including Type 2.1 (declaration of compliance), 2.2 (test report with non-specific inspection), 3.1 (document from manufacturer with specific inspection and test results), and 3.2 (document prepared by manufacturer and purchaser representatives with specific inspection and test results). It provides details on the certification process, requirements for each certificate type, and how an independent third party would verify a Type 3.2 certificate for steel plates by inspecting the material, certificates, and test results to confirm compliance with standards.
This report summarizes an evaluation of Thermo-Tech Heating Devices' belt deicing systems for use at surface coal mines. The systems were found to operate safely when installed according to fire codes and manufacturer instructions. Both fuel oil and LP gas models use controls and valves that automatically shut down the fuel supply if flames are interrupted. Site visits confirmed the safety features worked properly. It was concluded the systems can reliably deice belts at mines if installed and maintained according to the recommendations, which include following electrical, piping and tank storage standards.
This document provides guidance on good manufacturing practices for medicinal gases in the European Union. It outlines requirements for personnel, premises, equipment, production, and documentation for the manufacture of active substance gases and medicinal gases. Key points include defining the delineation between active substance and medicinal product manufacture, ensuring traceability of batches, and preventing contamination during filling, storage, transport and refilling of cylinders and vessels. The annex seeks to define clear manufacturing standards while allowing for the specific nature of gaseous medicinal products.
This document certifies that the Graphite 52M FID Analyser manufactured by Environnement SA has been assessed and found to comply with specific performance standards for continuous emissions monitoring systems. The certificate provides details on the certification tests performed on the analyser, the certified measurement ranges and performance criteria it meets, as well as application and use guidelines.
This document discusses three levels of quality checks that are critical for building facades: 1) Product design, 2) Product manufacturing, and 3) System design and execution.
It provides examples to illustrate each level, including testing standards for product design compliance, certification processes for ensuring consistent manufacturing quality, and the use of mockups and on-site testing to validate custom system designs.
Proper quality checks at all three levels through standards compliance, third-party certification, and performance testing can help stakeholders deliver facade systems that meet design specifications and perform as intended over a building's lifespan.
This document provides information on qualification of gas chromatography equipment. It defines qualification as proving and documenting that equipment works correctly and leads to expected results. The types of qualification are design, installation, operational, and performance qualification. Installation qualification checks the installation site and equipment specifications. Operational qualification includes procedures to verify the system operates as intended. Performance qualification ensures the instrument performs within specified limits based on approved methods. The document then provides examples of tests and acceptance limits to check parameters of the gas chromatography inlet system, oven, and detector during periodic qualification.
This document discusses the validation of dry powder mixers, fluid bed dryers, and tray dryers used in pharmaceutical manufacturing. It describes the need for validation to ensure safety, reliability and consistent results. The validation process includes installation qualification to check equipment meets specifications, operational qualification to ensure proper functioning, and performance qualification to verify the equipment achieves expected results. Key parameters monitored include temperature, time, particle size and moisture content. The document provides details on qualification protocols and acceptance criteria to fully validate each piece of equipment.
Presentacion asme seccion viii division 2 2013leo040490
This document outlines steps for developing a quality control system manual (QCSM) to meet ASME Section VIII Division 2 regulations for pressure vessel certification. The key steps include:
1. Applying to ASME and the National Board for certification.
2. Developing detailed design calculations, drawings, materials specifications, and fabrication and inspection procedures meeting code requirements.
3. Implementing the QCSM in the shop and warehouses, and distributing it to all relevant personnel, to ensure all code requirements are met during construction.
4. Scheduling audits by the Authorized Inspector to confirm readiness for joint review and certification.
This document provides standards for evaluating the performance of coal cleaning equipment. It defines key performance criteria such as feed rate, reference density of separation, and accuracy of separation. Standard test procedures and analytical methods are outlined to determine performance parameters like partition density, separation sharpness, distribution of correctly and incorrectly placed material, ash error, and yield error. The document also provides recommendations for presenting coal cleaning test data in a uniform manner to allow for comparison of performance levels.
This document introduces changes to China's certification procedure and implementation rules for compulsory certification of audio/video and information technology products. Key points include: 1) Allowing type testing and factory inspections to be done in parallel for overseas factories; 2) Requiring a factory quality assurance statement be submitted with applications; 3) Specifying certification modes including type testing with follow-up inspections; and 4) Classifying factories from A to D based on inspection results, with more frequent inspections for lower classes.
Sports PARQUET FLOORS
9th March 2011: the European Parliament and the European Union Board adopt the Regulation (UE) N.305/2011, published on 4th April 2011 on the European Union Official Gazette and effective 20 days later.
The regulation of building products – the so-called CPR, acronym for Construction Products Regulation – is currently completing its transition period. As from 1st July 2013 it will be fully operating.
Among the innovations comparing to the Directive, we have the definition and use of the declaration of performance (replacing the compliance declaration). The change is not just about the terms, yet it involves a greater completeness and clarity of information matching the product.
Before entering the matter, it’s better to clarify that European EN Standards remains those already operating and issued for CPD Directive purposes.
The Commission will instruct CEN through a task for their revision and adjustment according to the basic requirements, as reported within enclosure no. I of CPR.
Seicom SPORTS PARQUET FLOORS has implemented EN 14904 Standard since the first edition of July 2006 (replacing former National standards).
In October 2007 we have prepared the manual for FPC management within the company; all products are inspected and tested according the procedures and documents referring to finished products supplied to customers are kept for 10 years, to guarantee traceability of the product.
All our suppliers must respect procedures and must supply and guarantee products in compliance with performance requirements.
http://www.seicom-italy.com/
This document is Defence Standard 91-91 Issue 7 Amendment 3, which specifies requirements for Aviation Turbine Fuel, Kerosine Type, Jet A-1. It establishes limits and acceptable ranges for various properties and tests of jet fuel through tables and references various test methods and annexes that provide additional details. It covers scope, materials, quality assurance, testing, and container requirements. The standard aims to ensure jet fuel meets performance and quality needs for use in military and civilian aircraft.
This document provides a performance qualification protocol for a compressed air with drier system. It outlines objectives, responsibilities, prerequisites, safety precautions, and describes the system. The validation methodology section details tests that will be performed to qualify the system, including oil content, water vapor, carbon monoxide, non-viable particle count, and viable particle count tests. Acceptance criteria for each test are provided. The validation plan matrix lists sampling points. Documentation and record keeping requirements are also described. The protocol is intended to validate that the compressed air system generates and distributes air meeting specified quality attributes.
The document discusses the qualification of gas chromatography equipment. It defines qualification and describes the types including design, installation, operational, and performance qualification. It provides details on installation qualification, operational qualification, and performance qualification. The document then discusses qualification of GC equipment specifically, outlining the objectives and levels of qualification. It provides examples of tests and parameters to check at each level, including for the inlet system, oven, and detector, with typical tolerance limits. The tests include overall tests to check multiple parameters at once.
1) The document outlines the validation process for a tablet compression machine, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
2) The IQ establishes that the machine is installed correctly according to specifications. The OQ tests that the machine operates as intended at different speeds and settings.
3) The PQ evaluates the machine's compression capabilities by producing tablets and testing for characteristics like content uniformity, thickness, hardness, and friability. The validation protocol brings all stages together in a report.
ASTM E 1417 - 2016 (Standard Practice for Liquid Penetrant Testing)....pdfHenry Loaiza
This document provides a standard practice for conducting liquid penetrant testing to examine nonporous metal and nonmetal components for discontinuities. It establishes minimum requirements including specifying qualified materials, equipment, facilities, personnel qualifications, and written procedures. Processes are classified based on penetrant type, method, and sensitivity level. The standard addresses precleaning, application of penetrant materials, examination, evaluation, and acceptance criteria to ensure effective nondestructive testing for defect detection.
Best 20 SEO Techniques To Improve Website Visibility In SERPPixlogix Infotech
Boost your website's visibility with proven SEO techniques! Our latest blog dives into essential strategies to enhance your online presence, increase traffic, and rank higher on search engines. From keyword optimization to quality content creation, learn how to make your site stand out in the crowded digital landscape. Discover actionable tips and expert insights to elevate your SEO game.
Your One-Stop Shop for Python Success: Top 10 US Python Development Providersakankshawande
Simplify your search for a reliable Python development partner! This list presents the top 10 trusted US providers offering comprehensive Python development services, ensuring your project's success from conception to completion.
Nunit vs XUnit vs MSTest Differences Between These Unit Testing Frameworks.pdfflufftailshop
When it comes to unit testing in the .NET ecosystem, developers have a wide range of options available. Among the most popular choices are NUnit, XUnit, and MSTest. These unit testing frameworks provide essential tools and features to help ensure the quality and reliability of code. However, understanding the differences between these frameworks is crucial for selecting the most suitable one for your projects.
This presentation provides valuable insights into effective cost-saving techniques on AWS. Learn how to optimize your AWS resources by rightsizing, increasing elasticity, picking the right storage class, and choosing the best pricing model. Additionally, discover essential governance mechanisms to ensure continuous cost efficiency. Whether you are new to AWS or an experienced user, this presentation provides clear and practical tips to help you reduce your cloud costs and get the most out of your budget.
TrustArc Webinar - 2024 Global Privacy SurveyTrustArc
How does your privacy program stack up against your peers? What challenges are privacy teams tackling and prioritizing in 2024?
In the fifth annual Global Privacy Benchmarks Survey, we asked over 1,800 global privacy professionals and business executives to share their perspectives on the current state of privacy inside and outside of their organizations. This year’s report focused on emerging areas of importance for privacy and compliance professionals, including considerations and implications of Artificial Intelligence (AI) technologies, building brand trust, and different approaches for achieving higher privacy competence scores.
See how organizational priorities and strategic approaches to data security and privacy are evolving around the globe.
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Is 13849. 1993
1. BUREAU OF INDIAN STANDARDS
CENTRAL MARKS DEPARTMENT-III
Our Ref: CMD-III/16:13849 25 May 2005
Subject: Implementation of the revised STI, Doc: STI/13849/4, July 2005, due to Printing
of Amendment No. 5, March 2005 to IS 13849:1993- Specification for Portable Fire
Extinguisher, Dry Powder Type (stored pressure).
Amendment No. 5 to IS 13849:1993 has been published (copy enclosed).The requirement of
Fire Knock down Test has been deleted and Test for adhesion of Plastic lining (Type Test) has been
included besides other changes.
Vide CMD circular No. CMD-III/16:13849 dated 17 May 2004 Amendment No.3 & 4 to IS
13849:1993 were implemented keeping in abeyance “Fire Knock down Test” on Fire Extinguisher
in view of CED’s note CED 22/A-2.12 dated 5 May 2004 informing that the convener of the
concerned committee has opined that fire knock down test for fire extinguisher was not required
for the time being as the Fire ratings were not covered in the standard in case , dry powder was
conforming to IS 4308 for B,C class or 14609 for A, ,B C class. Further CED had informed that
necessary actions were being taken by them to process the necessary amendment.
Amendment No.5 takes care of the aspect of“ Fire Knock down Test” on Fire Extinguisher.
In order to implement Amendment No. 5 to IS 13849:1993, the STI document has been
revised as Doc:STI/13849/4 , July 2005 (copy enclosed).Applicability of the changes may be
examined and availability of additional testing facilities & conformance of product be verified in
respect of operating licences. Implementation of the revised STI be ensured w.e.f. 01 Aug 2005.
All new applications be processed taking into account Amendment No. 5 to the standard.
Applications where samples have already been tested as per IS 13849:1993, without considering
Amendment No. 5 to the standard and where the case is in advance stage may be processed as it is
for grant of licence after obtaining an undertaking from the applicant that the revised STI shall be
implemented w.e.f. 01 August 2005.
(B.K. Shreevastava)
Director (CMD-III)
Encl:As above
D&H (CMD-III)
DDGM
All ROs /BOs /CL
c.c. CMD-1
CED-For gazette notification
2. -
DOC: STI/13849/4
July 2005
SCHEME OF TESTING AND INSPECTION
FOR CERTIFICATION OF
PORTABLE FIRE EXTINGUISHER DRY POWDER TYPE
(STORED PRESSURE) ACCORDING TO IS 13849:1993
(Including Amendment No. 1 to 5)
1. LABORATORY – A laboratory shall be maintained which shall be suitably equipped and
staffed where different tests given in the specification shall be carried out in accordance with the
methods given in the specification.
2. TEST RECORDS - All records of tests, inspection and calibration shall be kept in suitable
forms approved by the Bureau.
2.1 All testing apparatus/measuring instruments shall be periodically checked and calibrated and
records of such checks/calibration shall be maintained.
2.2 Copies of any records and other connected papers that may be required by the Bureau shall
be made available at any time on request.
3. QUALITY CONTROL – It is recommended that, as far as possible, Statistical Quality
Control (SQC) methods may be used for controlling the quality of the product during production as
envisaged in this Scheme [See IS 397(Part I):2003, IS 397(Part 2):2003 and IS 397(Part 3):2003].
3.1 In addition, effort should be made to gradually introduce a Quality Management System in
accordance with IS/ISO 9000 series as appropriate to the activities of the organization.
4. STANDARD MARK – The Standard Mark, as given in Column (1) of the First
Schedule of the licence, shall be marked on each extinguisher, provided always that the
extinguisher to which this mark is applied conforms to every requirement of the specification..
5.0 OPTIONAL REQUIREMENT FOR ECO MARK - Requirements of clause 11.1 to
11.2.5 of the IS standard shall be complied in case the licence includes ECO mark. This is,
however an optional requirement.
.
1
3. DOC: STI/13849/4
July 2005
6 MARKING - In addition the following information shall be clearly and permanently
marked on each extinguisher
a) Name of the manufacturer or trade mark, if any;
b) Method of operation in prominent letters;
c) The words 'Dry powder Extinguisher' stored pressure type;
d) The capacity of the extinguisher in kg;
e) The words 'Recharge After Use';
f) A declaration to the effect that the body of the extinguisher has been tested to a
pressure of 30 kgf/cm2;
g) The words Keep This End Up while using;
h) Letter indicating the suitability of the unit for various classes of fires;
i) Year of manufacture and Sl No. of the extinguisher;
j) Class of Fire, BC or ABC; and
k) Control Unit No. to trace back factory test records.
l) Licence No. (CM/L........)
m) Criteria for which the product has been awarded ECO mark (if applicable).
7. LEVELS OF CONTROL - The tests, as indicated in Table 1 attached and at the levels of
control specified therein, shall be carried out on the whole production of the factory which is
covered by this scheme and appropriate records and charts maintained in accordance with paragraph
2.0 above. All the production which conforms to the Indian Standards and covered by the licence
shall be marked with certification mark of the Bureau.
7.1 CONTROL UNIT - For the purpose of this scheme extinguisher of the same capacity
using the dry powder from the same consignment, undergone similar conditions at the time of
manufacturing and using raw material from the same consignment as per table 1 of IS 13849:1993,
manufactured in one shift shall constitute a control unit.
7.1.1 Each extinguisher shall pass the test capacity, dry nitrogen, shape, painting, leakage test.
However, if one or more extinguisher do not satisfy the specified requirement in respect of the
specification, the extinguisher in the control unit shall be rejected for the purpose of marking.It may
however be rectified and such rectified extinguisher when tested shall satisfy the specified
requirements for the purpose of marking.
7.2 On the basis of tests and inspection, the decision regarding conformity or otherwise of the
control unit to a given requirement shall be made.
8.0 In respect of all other clauses of the specification the factory will maintain appropriate
control and checks to ensure that their product conforms to the various requirements of this
specification.
2
4. DOC: STI/13849/4
July 2005
9 REJECTIONS – A separate record shall be maintained giving information relating to the
rejection of the production not conforming to the requirements of the specification and the method
of its disposal. Such material shall in no circumstances be stored together with that conforming to
the specification.
10 SAMPLES – The licensee shall supply, free of charge, the samples required in accordance
with the Bureau of Indian Standards (Certification) Regulations, 1988, as subsequently amended,
from the factory or godowns. The Bureau shall pay for the samples taken by it from the open
market.
11 REPLACEMENT – Whenever a complaint is received soon after the goods with Standard
Marks have been purchased and used, and if there is adequate evidence that the goods have not
been misused, defective goods or their components are replaced or repaired free of cost by the
licensee in case the complaint is proved to be genuine and the warranty period (where applicable)
has not expired. The final authority to judge the conformity of the product to the Indian Standard
shall be with the Bureau.
11.1 In the event of any damages caused by the goods bearing the Standard Mark, or claim being
filed by the consumers against BIS Standard Mark and not “conforming to” the relevant Indian
Standard, entire liability arising out of such non conforming product shall be of licensee and BIS
shall not in any way be responsible in such cases.
12.0 STOP MARKING – The marking of the product shall be stopped under intimation to the
Bureau if, at any time, there is some difficulty in maintaining the conformity of their product to the
specification, or the testing equipment goes out of order. The marking may be resumed as soon as
the defects are removed under intimation to Bureau.
12.1 The marking of the product shall be stopped immediately if directed to do so by Bureau for
any reason. The marking may then be resumed only after permission by the Bureau. The
information regarding resumption of markings shall also be sent to the Bureau.
13.0 PRODUCTION DATA – The licensee shall send to BIS as per the enclosed
proforma-1 to be authenticated by a Chartered Accountant or by the manufacturer by giving an
affidavit/undertaking, a statement of quantity produced, marked and exported by him and the trade
value thereof at the end of each operative year of the licence.
Table 1………
3
5. DOC: STI/13849/4
July 2005
IS 13849:1993
PORTABLE FIRE EXTINGUISHER, DRY POWDER
TYPE (STORED PRESSURE)
TABLE 1 LEVELS OF CONTROL
(Para 7 of the Scheme of Testing and Inspection)
TEST DETAILS LEVELS OF CONTROL
Cl. Requirement Test Methods No. Frequency Remarks
of
Clause Reference samples
4.1 Dry Powder 4.1 IS 4308 One Each No Testing is necessary if
(For BC) consignment material is ISI marked or
IS 14609 accompanied with test
(For ABC) certificate showing
conforming to relevant IS.
4.1 Capacity 4.1 IS 13849:1993 One Every one hour
production of
each capacity
4.2 Dry - IS 1747:1972 One Every one hour
Nitrogen/dry production
air
5.1 Material's Table 1 IS 13849:1993 One Each No Testing is necessary if
detail Consignment material is ISI marked or
accompanied with test
certificate showing
conforming to relevant IS.
6. Shape 6.0 -do- One Each
extinguisher
7.1 Construction 7.1 -do- One Every one hour At the time of design
7.1.1, -do- production approval and prototype
7.1.2 & -do- One
7.1.3 -do-
7.2 Gas space 7.2 & 10.5 -do- One Every hour
production
7.3 Neck ring 7.3 -do- 1% Each control Valve shall be as per Fig-1,
unit
7.4 Valve 7.4 -do- 1% -do-
7.5 Discharge 7.5.1 -do- 1% -do-
fittings to 7.5.4
4
6. DOC: STI/13849/4
July 2005
IS 13849:1993
PORTABLE FIRE EXTINGUISHER, DRY POWDER
TYPE (STORED PRESSURE)
TABLE 1 LEVELS OF CONTROL
(Para 7 of the Scheme of Testing and Inspection)
TEST DETAILS LEVELS OF CONTROL
Cl. Requirement Test Methods No. Frequency Remarks
of samples
Clause Reference
8.1 & Anti-corrosive 8.1 IS 13849:93 One Each control .
8.2 treatment & 8.2 IS 3203 unit.
8.1.1 Adhesion of 8.1.1 IS 13849:93 -do- -do-
Plastic Lining
9. Painting 9.1, 9.2 IS 13849:93 Each fire
& 9. 3 extinguisher
10.1 Hydrostatic 10.1 -do- Five Each control
Pressure Test unit
10.2 Ultimate 10.2 -do- One Once in a week
failure test
10.3 Leakage Test 10.3 -do- Each fire
extinguisher
10.4 Drop Test 10.4 -do- One Every three
months
10.5.1 Performance 10.5.1 -do- One Each control
Test unit
11 Marking 11 -do- - Each Fire
Extinguisher
5