The document discusses Telstar's Pura range of sterility test isolators. It notes that ergonomic trials are performed early in development to prevent issues. The Pura range was developed using this process and 3D modeling software. Features of the Pura isolators include various chamber sizes, glove ports, materials suitable for hydrogen peroxide decontamination, and compliance with ISO standards for sterility testing. Benefits include reduced contamination risk and costs compared to traditional cleanrooms. Options include different decontamination systems and monitoring equipment.
This one-page document provides an overview of products for antimicrobial susceptibility testing, including:
- M.I.C.Evaluator strips for determining minimum inhibitory concentrations of various antimicrobials.
- Recommended media such as Sensitest Agar, Wilkins-Chalgren Anaerobe Agar and Broth.
- Accessories like disc dispensers, desiccant sachets, and turbidometers.
- A list of available antimicrobial susceptibility testing discs.
This document discusses visual inspection of drug products for defects and container integrity. It summarizes regulations around ensuring container closure systems provide adequate protection and rejecting drug products that fail to meet standards. The document also discusses recalls related to visible particulates and FDA observations around visual inspection issues. It provides an overview of differences between human and automated inspections. A survey found manual inspection is most common and discusses typical inspection conditions and rejection rates. Key aspects of USP <790> on visible particulates in injections are also summarized, including inspection illumination, times, and acceptance criteria. The document concludes that while inspection cannot ensure products are 100% defect free, practical limits and patient risk guide the process.
Visual inspection is an important first step in the particle identification process for pharmaceutical liquids and presentations. It provides an overview of product characteristics and defects that can be connected to particle content. Membrane microscopic counting is a key technique for quantifying particulate matter at various size ranges. Proper isolation, characterization, and identification of particles is essential to determine their origin and ensure product quality and stability.
Internal pressurization bubble testing system for astm f2096huzaifa_ujjain
This document discusses Burhani Hardware's Internal Pressurization Bubble Testing System for leak detection in packaged foods, medical products, and other consumer goods. The system pressurizes test samples and detects leaks using the bubble emission method, identifying leaks as small as 250 microns within 10-30 seconds. It is manufactured according to ASTM F2096 and can test various container types and sizes. The system features an acrylic tank with lid, safety features, and adjustable feet or lockable casters to test samples for seal reliability and identify leak locations.
Internal pressurization bubble testing system for astm f2096huzaifa_ujjain
This document discusses Burhani Hardware's Internal Pressurization Bubble Testing System for detecting leaks in packaged products. The system pressurizes test samples and detects leaks using the bubble emission method. It can test a variety of package types and is sensitive to leaks as small as 250 microns. The system provides results within 10 to 30 seconds and helps identify leak locations. It is useful for quality control in product development and manufacturing environments.
Compendial requirements for particle testing 2014D Scott Aldrich
This document discusses particle counting and identification strategies, outlining compendial guidance from the US, EU, and Japan. It defines particulate matter and describes size ranges and categories. Visible and subvisible particles are monitored using techniques like light obscuration and membrane microscopy. Harmonized limits for subvisible particles are outlined in USP <788>. The document stresses that particle investigation requires a holistic approach using various characterization methods.
The document discusses Telstar's Pura range of sterility test isolators. It notes that ergonomic trials are performed early in development to prevent issues. The Pura range was developed using this process and 3D modeling software. Features of the Pura isolators include various chamber sizes, glove ports, materials suitable for hydrogen peroxide decontamination, and compliance with ISO standards for sterility testing. Benefits include reduced contamination risk and costs compared to traditional cleanrooms. Options include different decontamination systems and monitoring equipment.
This one-page document provides an overview of products for antimicrobial susceptibility testing, including:
- M.I.C.Evaluator strips for determining minimum inhibitory concentrations of various antimicrobials.
- Recommended media such as Sensitest Agar, Wilkins-Chalgren Anaerobe Agar and Broth.
- Accessories like disc dispensers, desiccant sachets, and turbidometers.
- A list of available antimicrobial susceptibility testing discs.
This document discusses visual inspection of drug products for defects and container integrity. It summarizes regulations around ensuring container closure systems provide adequate protection and rejecting drug products that fail to meet standards. The document also discusses recalls related to visible particulates and FDA observations around visual inspection issues. It provides an overview of differences between human and automated inspections. A survey found manual inspection is most common and discusses typical inspection conditions and rejection rates. Key aspects of USP <790> on visible particulates in injections are also summarized, including inspection illumination, times, and acceptance criteria. The document concludes that while inspection cannot ensure products are 100% defect free, practical limits and patient risk guide the process.
Visual inspection is an important first step in the particle identification process for pharmaceutical liquids and presentations. It provides an overview of product characteristics and defects that can be connected to particle content. Membrane microscopic counting is a key technique for quantifying particulate matter at various size ranges. Proper isolation, characterization, and identification of particles is essential to determine their origin and ensure product quality and stability.
Internal pressurization bubble testing system for astm f2096huzaifa_ujjain
This document discusses Burhani Hardware's Internal Pressurization Bubble Testing System for leak detection in packaged foods, medical products, and other consumer goods. The system pressurizes test samples and detects leaks using the bubble emission method, identifying leaks as small as 250 microns within 10-30 seconds. It is manufactured according to ASTM F2096 and can test various container types and sizes. The system features an acrylic tank with lid, safety features, and adjustable feet or lockable casters to test samples for seal reliability and identify leak locations.
Internal pressurization bubble testing system for astm f2096huzaifa_ujjain
This document discusses Burhani Hardware's Internal Pressurization Bubble Testing System for detecting leaks in packaged products. The system pressurizes test samples and detects leaks using the bubble emission method. It can test a variety of package types and is sensitive to leaks as small as 250 microns. The system provides results within 10 to 30 seconds and helps identify leak locations. It is useful for quality control in product development and manufacturing environments.
Compendial requirements for particle testing 2014D Scott Aldrich
This document discusses particle counting and identification strategies, outlining compendial guidance from the US, EU, and Japan. It defines particulate matter and describes size ranges and categories. Visible and subvisible particles are monitored using techniques like light obscuration and membrane microscopy. Harmonized limits for subvisible particles are outlined in USP <788>. The document stresses that particle investigation requires a holistic approach using various characterization methods.
Esco Containment Barrier Isolator (CBI) facilitates the isolation of a product or process while providing the required conditions for a sterile/ aseptic environment. It is configured to operate at positive or negative pressure. This equipment provides a comprehensive range of personnel
and product protection in addition to protection for the surrounding work areas and the environment.
CBI's design has complete compliance to PIC/s and EU cGMP standardswith its 19 mm radius coved internal corners in a single piece chamber (no perforations or grilles for contaminants to be trapped on all 4 corners). Its Rear Return Filter ensures that ducts are not contaminated. The system comes in either recirculatory or single pass airflow.
Applications
• Pharmacy Compounding (Chemotherapy/TPN)
• As a Class III Cabinet for Biosafety Levels (BSL) 3 and 4
• Small Batch Sterility Testing
• Small-scale Potent Material Handling
• Cell Processing
• Aseptic Processing
• Research and Development
FEC manufactures a Benne wart flex tester intended to determine the resistance of components and materials to crack growth during repeated flexing. The tester can flex samples at 90 degrees up to 150 cycles per minute using a 30mm diameter mandrel. It is powered by a 1/2 HP single phase motor and has a six digit counter. The flex tester is commonly used to test the resistance to cuts and cracks of shoe outsoles during flexing according to various international standards.
FEC manufactures a Benne wart flex tester intended to determine the resistance of components and materials to crack growth during repeated flexing. The tester can flex samples at 90 degrees up to 150 cycles per minute using a 30mm diameter mandrel. It is powered by a 1/2 HP single phase motor and has a six digit counter. The flex tester is commonly used to test the resistance to cuts and cracks of shoe outsoles during flexing according to various international standards.
MDC Machine Design has recently worked on a variety of projects including:
1. Developing an autosampler for highly viscous compounds and a control cabinet for a pharmaceutical application.
2. Designing animal workstations for behavioral studies and an attitude sensor.
3. Fabricating machines for pharmaceutical processing, studying impacts on multi-dose vials, and containing vacuum pump noise and heat in a laboratory.
The FlangeScanner uses phased array ultrasound technology to inspect the integrity of raised face flanges without disassembling or removing bolts, eliminating downtime. It can scan flange sizes from #150 to #2500 simultaneously or individually. The scanner provides accurate and repeatable inspections to monitor known defects and identify problem flanges before outages.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
This document evaluates the physical properties of a vinyl rail profile according to sections of ICC-ES AC 174. It summarizes:
1. A vinyl rail sample was tested for temperature and moisture effects, UV resistance, and freeze-thaw resistance according to ICC-ES AC 174 sections.
2. Test results showed failures loads and stiffness deviations within requirements, except at 52°C which exceeded 25%.
3. The flame spread of the baluster met requirements.
4. Based on test results, the report concludes that test loads for rails should be increased by 11.52% when testing guard and handrail performance requirements.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
Visual Inspection in Parenteral Drug Products
The document discusses visual inspection of parenteral drug products. It notes that visual inspection is needed to detect defects like particulate matter that could impact patient safety. Inspection is required by compendial and regulatory standards to ensure products are essentially free of visible particles. The summary describes the types of defects classified as critical, major, or minor and the acceptable quality limits for each. It also provides an overview of manual, semi-automated, and automated inspection methods and defines what constitutes a "visible particle" during the inspection process.
Smith & Associates uses an in-house testing lab with advanced equipment to verify product authenticity and functionality. The lab conducts thorough quality control tests including x-ray inspection, chemical analysis, and visual inspection. Smith's inspectors are trained to identify counterfeit components and the company offers comprehensive functionality testing on a wide range of components.
Lab Sales Corporation offers a wide range of laboratory chemicals, industrial chemicals, scientific instruments, and laboratory glassware. It has been operating since 1971 and is ISO 9001:2008 certified. The company procures products from reliable vendors and tests them to ensure they meet quality standards before supplying to customers. It aims to provide customized and quality products to customers in a timely manner.
Bottles (pet, preform & glass) testing instrumentsPacorr Testing
The PET bottles are often transported by stacking them upon each other. This might cause the bottle in
the bottom row to buckle, compress and deform. The manufacturers need to test the amount of load that
the bottles can bear when they are put under compressive forces. The Top Load Tester- Digital is the
instrument that gives an exact test result for the buckling capacity of the bottles or PET containers.
The document discusses SaatiCare fabrics that are used in various medical applications such as infusion and transfusion filters. It describes the fabrics' features such as being made of polyester or polyamide, having uniform pore sizes ranging from 7-2000 microns, and having high open area, strength, and dimensional stability. It also discusses the fabrics' precise filtration capabilities and how they minimize pressure loss and maximize flow rates. Next, it outlines the various tests the fabrics undergo and certifications they can receive. Finally, it provides examples of specific medical applications for the fabrics including blood bags, infusion filters, and diagnostic applications like spyrometers.
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Inf...CDC NPIN
The document describes a prototype for a next generation rapid HIV test developed by OraSure Technologies. The prototype aims to detect HIV antibodies earlier than current rapid tests by achieving sensitivity similar to 3rd generation ELISA tests while maintaining a 10-minute test time. Performance studies showed the prototype detected HIV antibodies earlier than a FDA-approved rapid test in 50% of seroconversion panels tested, with an average of 5 days earlier detection. Specificity of the prototype was 99.87% in plasma samples. The prototype achieved all design goals of earlier detection of HIV antibodies during acute infection and a reduced test time.
This technical paper describes the development of an inline foam analysis system to detect foreign matter in beer bottles during the bottling process. The system aims to automate the human "foampicking" process of visually inspecting foam collars. Through laboratory and field testing, the system was able to accurately measure foam collar parameters and detect bottles containing foreign matter, rejecting fewer good bottles than human inspectors while catching more bottles with issues. The system was successfully installed in several breweries.
UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UL Webinar - Updates to the Regulatory Framework in Korea and their impact to...ulmedical
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.
Presentation made to ASQ section 1508 Tampa/St Petersburg chapter by Sam Farney, Principal Supply Chain Advisors on April 13th 2009. Copyrighted material, all rights reserved
eHealth - Medical Systems Interoperability & Mobile Healthulmedical
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices.
This webinar was presented by UL eHealth experts on October 30, 2013.
Esco Containment Barrier Isolator (CBI) facilitates the isolation of a product or process while providing the required conditions for a sterile/ aseptic environment. It is configured to operate at positive or negative pressure. This equipment provides a comprehensive range of personnel
and product protection in addition to protection for the surrounding work areas and the environment.
CBI's design has complete compliance to PIC/s and EU cGMP standardswith its 19 mm radius coved internal corners in a single piece chamber (no perforations or grilles for contaminants to be trapped on all 4 corners). Its Rear Return Filter ensures that ducts are not contaminated. The system comes in either recirculatory or single pass airflow.
Applications
• Pharmacy Compounding (Chemotherapy/TPN)
• As a Class III Cabinet for Biosafety Levels (BSL) 3 and 4
• Small Batch Sterility Testing
• Small-scale Potent Material Handling
• Cell Processing
• Aseptic Processing
• Research and Development
FEC manufactures a Benne wart flex tester intended to determine the resistance of components and materials to crack growth during repeated flexing. The tester can flex samples at 90 degrees up to 150 cycles per minute using a 30mm diameter mandrel. It is powered by a 1/2 HP single phase motor and has a six digit counter. The flex tester is commonly used to test the resistance to cuts and cracks of shoe outsoles during flexing according to various international standards.
FEC manufactures a Benne wart flex tester intended to determine the resistance of components and materials to crack growth during repeated flexing. The tester can flex samples at 90 degrees up to 150 cycles per minute using a 30mm diameter mandrel. It is powered by a 1/2 HP single phase motor and has a six digit counter. The flex tester is commonly used to test the resistance to cuts and cracks of shoe outsoles during flexing according to various international standards.
MDC Machine Design has recently worked on a variety of projects including:
1. Developing an autosampler for highly viscous compounds and a control cabinet for a pharmaceutical application.
2. Designing animal workstations for behavioral studies and an attitude sensor.
3. Fabricating machines for pharmaceutical processing, studying impacts on multi-dose vials, and containing vacuum pump noise and heat in a laboratory.
The FlangeScanner uses phased array ultrasound technology to inspect the integrity of raised face flanges without disassembling or removing bolts, eliminating downtime. It can scan flange sizes from #150 to #2500 simultaneously or individually. The scanner provides accurate and repeatable inspections to monitor known defects and identify problem flanges before outages.
Orally Inhaled & Nasal Drug Products: delivery systems, components and specialist services for a growing industry sector” This edition is one in the series of ONdrugDelivery publications.
This document evaluates the physical properties of a vinyl rail profile according to sections of ICC-ES AC 174. It summarizes:
1. A vinyl rail sample was tested for temperature and moisture effects, UV resistance, and freeze-thaw resistance according to ICC-ES AC 174 sections.
2. Test results showed failures loads and stiffness deviations within requirements, except at 52°C which exceeded 25%.
3. The flame spread of the baluster met requirements.
4. Based on test results, the report concludes that test loads for rails should be increased by 11.52% when testing guard and handrail performance requirements.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
Visual Inspection in Parenteral Drug Products
The document discusses visual inspection of parenteral drug products. It notes that visual inspection is needed to detect defects like particulate matter that could impact patient safety. Inspection is required by compendial and regulatory standards to ensure products are essentially free of visible particles. The summary describes the types of defects classified as critical, major, or minor and the acceptable quality limits for each. It also provides an overview of manual, semi-automated, and automated inspection methods and defines what constitutes a "visible particle" during the inspection process.
Smith & Associates uses an in-house testing lab with advanced equipment to verify product authenticity and functionality. The lab conducts thorough quality control tests including x-ray inspection, chemical analysis, and visual inspection. Smith's inspectors are trained to identify counterfeit components and the company offers comprehensive functionality testing on a wide range of components.
Lab Sales Corporation offers a wide range of laboratory chemicals, industrial chemicals, scientific instruments, and laboratory glassware. It has been operating since 1971 and is ISO 9001:2008 certified. The company procures products from reliable vendors and tests them to ensure they meet quality standards before supplying to customers. It aims to provide customized and quality products to customers in a timely manner.
Bottles (pet, preform & glass) testing instrumentsPacorr Testing
The PET bottles are often transported by stacking them upon each other. This might cause the bottle in
the bottom row to buckle, compress and deform. The manufacturers need to test the amount of load that
the bottles can bear when they are put under compressive forces. The Top Load Tester- Digital is the
instrument that gives an exact test result for the buckling capacity of the bottles or PET containers.
The document discusses SaatiCare fabrics that are used in various medical applications such as infusion and transfusion filters. It describes the fabrics' features such as being made of polyester or polyamide, having uniform pore sizes ranging from 7-2000 microns, and having high open area, strength, and dimensional stability. It also discusses the fabrics' precise filtration capabilities and how they minimize pressure loss and maximize flow rates. Next, it outlines the various tests the fabrics undergo and certifications they can receive. Finally, it provides examples of specific medical applications for the fabrics including blood bags, infusion filters, and diagnostic applications like spyrometers.
Performance of a Prototype Rapid, Point-of-Care Test* for Identifying HIV Inf...CDC NPIN
The document describes a prototype for a next generation rapid HIV test developed by OraSure Technologies. The prototype aims to detect HIV antibodies earlier than current rapid tests by achieving sensitivity similar to 3rd generation ELISA tests while maintaining a 10-minute test time. Performance studies showed the prototype detected HIV antibodies earlier than a FDA-approved rapid test in 50% of seroconversion panels tested, with an average of 5 days earlier detection. Specificity of the prototype was 99.87% in plasma samples. The prototype achieved all design goals of earlier detection of HIV antibodies during acute infection and a reduced test time.
This technical paper describes the development of an inline foam analysis system to detect foreign matter in beer bottles during the bottling process. The system aims to automate the human "foampicking" process of visually inspecting foam collars. Through laboratory and field testing, the system was able to accurately measure foam collar parameters and detect bottles containing foreign matter, rejecting fewer good bottles than human inspectors while catching more bottles with issues. The system was successfully installed in several breweries.
UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UL Webinar - Updates to the Regulatory Framework in Korea and their impact to...ulmedical
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.
Presentation made to ASQ section 1508 Tampa/St Petersburg chapter by Sam Farney, Principal Supply Chain Advisors on April 13th 2009. Copyrighted material, all rights reserved
eHealth - Medical Systems Interoperability & Mobile Healthulmedical
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices.
This webinar was presented by UL eHealth experts on October 30, 2013.
Devices Sponsor Information Day: 1 - Conformity AssessmentTGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
The document outlines rules for inspecting product dossiers according to two groups. Dossiers are inspected by the Registration Department or Surveillance Department depending on the reason for inspection. Re-inspection may occur based on risk assessment or changes to specifications, packaging, or manufacturing location. Test limits must comply with pharmacopeial standards and any updates requiring second group inspection must be submitted within 6 months.
This document discusses auditing of vendors that supply capsules and sterile products to pharmaceutical companies. It describes the benefits of conducting vendor audits such as cost savings, process improvements, and risk reduction. The document outlines the vendor selection process and procedures for auditing vendors. Key areas examined in a vendor audit include facilities, personnel, validation, documentation, and finished product quality controls. Manufacturing processes for capsules and sterile products are also summarized. The checklist covers auditing of vendors' premises, equipment, documentation, samples, and compliance with regulations.
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.
SteriSense is a brand new and innovative device for
Electronic Bowie Dick Tests that is unmatched in
accuracy, performance and reliability. ISO 11140-4
Compliant
Learn testing solutions for pre-filled, hypodermic, single-use, and needle-based injection systems, as required per ISO 11040-4, ISO 7886-1, ISO 8537, ISO 80369-20, and ISO 11608.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
This document provides an overview of equipment validation processes for various sterilization and testing equipment. It discusses the qualification stages of design, installation, operational, and performance qualification. Specific equipment validated include autoclaves, ethylene oxide sterilizers, radiation sterilizers, filters, and dissolution apparatus. Validation procedures for each involve installation checks, qualification tests, process validation, and establishing the equipment is fit for intended use.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
Documentation with respect to release of finished pharmaceutical productMadhuraNewrekar
Documentation is a crucial part of the quality assurance system and is needed in every aspect of pharmaceutical manufacturing. Important documentation with respect to final product release in pharmaceutical industry is explained in brief.
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.
The document discusses laboratory accreditation. It explains that laboratory accreditation provides formal recognition of competent labs and allows customers to identify reliable testing services. The National Accreditation Board for Testing and Calibration Laboratories (NABL) is India's authorized accreditation body. NABL uses international standards to evaluate labs and accredits them for a maximum of 2 years through a 5 stage process involving an application, assessment, corrective actions, review, and renewal. Accreditation benefits labs through increased business and confidence in their testing data.
Spraying Systems Co., Korea was founded in 1994 as one of global manufacturing facilities of Spraying Systems Co. Spraying Systems Co. was founded 77 years ago in the Chicago area. We have ten manufacturing locations around the world and many of sales offices in more than 90 countries to provide local sales and technical support. We provide engineering and application assistance to help customers optimize their spray applications. Our sales engineers are dedicated specialists in spray technology.
Please visit our website www.spray.co.kr , or contact us +82-32-821-5633
The document discusses NABL accreditation, which is provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL accredits laboratories to ensure they meet technical standards for competence. The accreditation process involves assessments of a laboratory's management system, technical performance, and participation in proficiency testing. Receiving NABL accreditation improves customer confidence and allows access to domestic and international markets by demonstrating a laboratory's technical competence meets international standards.
Components of a Successful Packaging Shelf-Life StudyNAMSA
A key design attribute of a terminally sterilized medical device is for the device to maintain sterility throughout the labeled shelf-life. This presentation discusses a few of the elements that are necessary for a successful packaging shelf-life.
Visual inspection of parenteral products is conducted to detect defective units and ensure compliance with regulatory requirements that injectable products be free of visible particles. All filled containers undergo 100% visual inspection against black and white backgrounds under controlled lighting. Inspections are usually manual but can also be automated. Post-inspection sampling is required and failures can result in batch rejection. Any particles detected must be characterized to identify the source and ensure appropriate corrective actions. Recalls are sometimes necessary when particles are found, posing a risk to patient safety. Thorough training and documentation are needed to support consistent visual inspection.
SLK Technosystems was founded in the year 2006 to meet requirements of various organizations in the field of PVC ID Cards and Smart Card Solutions. The initial business activity concentrated on Smart Card Solutions, manufacture of Card Fusing Machines, ID Cards and Card Die-Cutters.
Similar to UL inmetro non active devices - 2012 (20)
2. Certification Required Products
• Sterile hypodermic syringes for single use
• Sterile hypodermic syringes for single use, FOR POWER-DRIVEN
SYRINGE PUMPS
• Sterile single-use syringes, with or without needle, FOR INSULIN
• Sterile hypodermic needles for single use
• Sterile injection needles for single use (DENTISTRY)
• Infusion equipment for medical use (infusion sets for single use, GRAVITY
FEED)
• Infusion equipment for medical use (infusion equipment for use with
PRESSURE INFUSION APPARATUS)
• Transfusion equipment for medical use (transfusion sets for single use)
Applicable legislation (all published on 29-DEC-2011):
- Ordinance INMETRO # 501: needles
- Ordinance INMETRO # 502: infusion and transfusion equipment
- Ordinance INMETRO # 503: syringes
2
3. When is Certification Required?
1. To apply for new registration with ANVISA.
2. To revalidate current registrations.
3. To renew current registrations.
4. TO OBTAIN IMPORTATION CLEARANCE! Even products with valid
registrations are required to be certified to obtain clearance from customs.
Otherwise, products will be retained by customs at the port of entry.
5. DEADLINE: JUN-2013
3
4. Certification Process: Procedure
Two certification models are allowed: batch OR type testing with QMS
audit.
• Batch (ISO model 7): Samples are collected at the port of entry. Products
will be retained by customs until testing is completed.
• Type testing + QMS evaluation (ISO model 5): See table below:
# STEP WHERE? WHO DOES? STANDARD / CRITERIA
ISO audit
1 Manufacturing site Closest UL Office
(14 clauses from ISO 13485)
Manufacturing site
2 Collecting samples Closest UL Office
OR distribution center
Details in the next
Any 3rd party ILAC
3 Laboratory tests Any country slides
accredited laboratory
4 Analysis of test reports Any country Any UL qualified office
Engineering team
5 Issue of the certificate Brazil
(UL Brazil)
ISO audit + laboratory tests. Samples are collected from the manufacturing site
6 Annual Maintenance
(or distribution center) and market in an alternating fashion.
4
5. Certification Process: ISO Audit
The closet UL inspection center will verify the following clauses:
- 4.2.3: Control of documents.
- 4.2.4: Control of records.
- 7.2.3: Customer communication.
- 7.4.1: Purchasing Process.
- 7.4.3: Verification of purchased product
- 7.5.1: Control of production and service provision.
- 7.5.3: Identification and traceability.
- 7.5.5: Preservation of product.
- 7.6: Control of monitoring and measuring devices.
- 8.2.1: Customer Satisfaction.
- 8.2.4: Monitoring and measurement of product.
- 8.3: Control of nonconforming product.
- 8.5.2: Corrective action.
- 8.5.3: Preventive action.
5
6. Certification Process: Samples
• Must be collected by the certification company
• Can be collected at the manufacturing site OR at the distribution center
• Sample size is defined by the respective INMETRO ordinance as follows:
Initial Certification Annual Maintenance
Product # Batches Units TOTAL # Batches Units TOTAL
Sterile hypodermic syringes for single use 3 256 768 3 160 480
Sterile hypodermic syringes for single use for use with POWER-DRIVEN SYRINGE PUMPS 3 256 768 3 160 480
Sterile single-use syringes, with or without needle, FOR INSULIN 3 672 2016 3 420 1260
Sterile hypodermic needles for single use 3 1632 4896 3 1020 3060
Sterile injection needles for single use (DENTISTRY) 3 832 2496 3 520 1560
Infusion equipment for medical use (infusion sets for single use, GRAVITY FEED) 3 225 675 3 150 450
Infusion equipment for medical use (infusion equipment for use with PRESSURE INFUSION
3
APPARATUS) 225 675 3 150 450
Transfusion equipment for medical use (transfusion sets for single use) 3 210 630 3 140 420
• UL will collect 3 batches of samples. The second batch is sent for testing if the first one fails. The third
batch is sent for testing if the first fails but the second is approved.
• There is a zero error rejection criteria! If one sample fails, the entire batch is considered non-compliant.
6
7. Certification Process: Testing Standards for
Syringes
Standards Clauses
Sterile hypodermic syringes for single use
NBR ISO 7886-1 5 - 14
Sterile hypodermic syringes for single use, FOR POWER-DRIVEN
SYRINGE PUMPS
NBR ISO 7886-2 5-14, 14.3-14.5
Sterile single-use syringes, with or without needle, FOR INSULIN
NBR ISO 8537 5-12, 14
7
8. Certification Process: Testing Standards for
Needles
Standards Clauses
Sterile hypodermic needles for single use
NBR ISO 7864 4-9, 11-13
NBR ISO 594-1 3, 4.1-4.5
Sterile injection needles for single use - Dentistry
ISO 7885 4.1-4.3, 5, 5.2, 5.4, 6, 6.3
8
9. Certification Process: Testing Standards for
Infusion / Transfusion Equipment
Standards Clause
Infusion equipment for medical use – Infusion sets for single use gravity feed
NBR ISO 8536-4 6.1-6.9, 6.11-1.13, 7.1-7.3
ISO 8536-5 6.2-6.4
Infusion equipment for medical use – Infusion equipment for use with
pressure infusion apparatus
ISO 8536-8 6.1-6.6, 6.8-6.9, 6.11-6.14, 7
ISO 8536-5 6.14, 6.2-6.4
Transfusion equipment for medical use – Transfusion sets for single use
ISO 1136-4 5.1-5.5, 5.7-5.8, 5.11-5.12, 6.1-6.3
ISO 8536-5 6.2-6.4
9
10. Certification Process: UL File Construction –
Issue of the Certificate - Marks
• After completion of the ISO audit and laboratory tests, the UL engineer will
be able to finalize the construction of the UL file and issue the certificate.
The certificate is valid for 5 years and is subject to annual maintenance. The
certificate is then published on both UL’s on-line directory and INMETRO’s
website.
• Usage of the certification marks is mandatory on the primary packaging of
the device (see below; minimum sizes; other colours also allowed). OCP
stands for “Product Certification Organization”. UL provides the UL mark
graphic files to its customers.
50 mm 20 mm 11 mm
10
11. Certification Process: Maintenance
Certification maintenance consists of an annual ISO audit and
laboratory tests. The procedure for the audit and tests is the same as
those performed in the initial certification, except for 2 major
differences:
• Reduced number of samples for testing (please see slide 8)
• Samples are collected from the manufacturing site (or distribution center)
and market in an alternating fashion.
11
12. FAQ
1. Is ISO 13485 certification mandatory? No, it’s not necessary, but the initial
audit carried out by UL is based on this standard.
2. Are tests performed by the manufacturer at its own facilities valid? Only
tests performed by 3rd party ILAC accredited laboratories are accepted.
3. Who performs the ISO audit? Any UL office with qualified ISO staff can
carry out the audit on behalf of UL Brazil.
4. How long does the ISO audit take? It takes one day for ISO verification
ONLY. If samples need to be collected, then additional days might be
required depending on the number of families of devices.
5. What is the criteria to divide products into families and who determines the
criteria? The criteria to group the different versions of the product into
families is determined by the respective INMETRO ordinance. UL
partners with the manufacturer to define the families.
12
14. THANK YOU.
• For more information on UL Health Sciences services visit:
http://ul.com/medical
• For more information on UL visit:
http://www.ul.com/global/eng/pages/corporate/aboutul/
• To see available UL marks visit:
http://ul.com/global/eng/pages/corporate/aboutul/ulmarks/mark/
• To locate your local UL contact visit:
http://www.ul.com/global/eng/pages/corporate/contactus/
14