This document summarizes a case study application of a web-based toolkit to assess risk at a SiO2 manufacturing company. The case study evaluated occupational exposure to nanoparticles during bag filling and mixing operations. Measured exposure data, including particle number concentrations and mass concentrations, were collected and used to estimate exposure levels. The exposure scenarios, risk characterization, and analysis of measured data are described for bag filling of 550kg of powder over 4 hours, mixing operations with 5kg of powder over 5 minutes, and a functionalization process. The results showed some measured exposures above limits but estimated exposures below limits when engineering and administrative controls were implemented.
Regulatory requirements for handling and disposal of hazardous chemical z3347081
There are many regulatory requirements for safe handling and disposal of hazardous chemicals. To avoid incurring personal liability, all laboratory users must address and actively support compliance with these laws and regulations.
The SMART-NANO project has enabled the development of an innovative, cost-effective technology platform that provides a solution "from sample-to-result" for the detection, identification, and measurement of engineered nanoparticles in a wide range of matrices.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Con motivo del aniversario de la LPRL, se inaugura el 10 de noviembre de 2015 la Jornada "20 años de la LPRL. Análisis y situación". En esta sesión se desarrolla una mesa de intervinientes que formaron parte del proceso de negociación de dicha ley. Entre ellos, D. José María de Bona Numancia como Vicepresidente de AIPREX.
La biblioteca RMM se concibe como una herramienta online gratuita y actualizable en la que se recopila y muestra para varios procesos industriales, profesionales o de laboratorio la efectividad de diferentes controles de ingeniería, controles administrativos y equipo de protección personal, con el fin de facilitar la decisión sobre el control y la herramienta de gestión de emplear en cada caso.
Regulatory requirements for handling and disposal of hazardous chemical z3347081
There are many regulatory requirements for safe handling and disposal of hazardous chemicals. To avoid incurring personal liability, all laboratory users must address and actively support compliance with these laws and regulations.
The SMART-NANO project has enabled the development of an innovative, cost-effective technology platform that provides a solution "from sample-to-result" for the detection, identification, and measurement of engineered nanoparticles in a wide range of matrices.
Mitigating Supply Chain Risk using Big Data AnalyticsMilliporeSigma
Access the interactive recording: https://bit.ly/2M2fvWS
Abstract:
Growth and expansion in the biopharmaceutical industry have increased the vulnerability of the global supply chain to disruptions. At the same time, stronger regulatory oversight has been introduced to assure patient access to life-saving drugs. To stay ahead of these two factors, we are making “risk-smart” decisions to balance investments in capacity and supply programs.
The routine, reliable supply of products to biopharmaceutical manufacturers depends upon a disciplined approach to supply chain management and risk management. This webinar will talk about supply chain risk management, and more specifically how big data analytics can help strengthen supply chains.
In this webinar, you will learn more on:
- Our supply risk management program
- How we use big data analytics to determine risks
Quality by Design Principles Applied to Sterilizing Filtration by Michael PayneMilliporeSigma
Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification.
In this webinar, you will learn to:
• Focus on practical QbD terms and approaches
• Highlight critical product quality aspects of sterile medicinal products
• Develop design and control spaces for sterilizing filtration
• Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production
Abstract:
Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.
Con motivo del aniversario de la LPRL, se inaugura el 10 de noviembre de 2015 la Jornada "20 años de la LPRL. Análisis y situación". En esta sesión se desarrolla una mesa de intervinientes que formaron parte del proceso de negociación de dicha ley. Entre ellos, D. José María de Bona Numancia como Vicepresidente de AIPREX.
La biblioteca RMM se concibe como una herramienta online gratuita y actualizable en la que se recopila y muestra para varios procesos industriales, profesionales o de laboratorio la efectividad de diferentes controles de ingeniería, controles administrativos y equipo de protección personal, con el fin de facilitar la decisión sobre el control y la herramienta de gestión de emplear en cada caso.
Taller: La guía técnica o manual técnico desarrollado en el marco del proyecto pretende ayudar a fabricantes y usuarios de nanomateriales (ENMs) en la selección de medidas de gestión de riesgo que garanticen la seguridad y salud de trabajadores expuestos.
La evaluación de los riesgos de caídas a distinto nivel en el .ámbito de la prevención de riesgos laborales. Una visión sistemática de un riesgo siempre presente realizada por un especialista altamente experimentado.
Brokerage session: expertise
Title: LEITAIT: offering expertise in treatment, reutilization, valorization and sanitation
Presented by Joan Roig, LEITAT
Taller: La guía técnica o manual técnico desarrollado en el marco del proyecto pretende ayudar a fabricantes y usuarios de nanomateriales (ENMs) en la selección de medidas de gestión de riesgo que garanticen la seguridad y salud de trabajadores expuestos.
La evaluación de los riesgos de caídas a distinto nivel en el .ámbito de la prevención de riesgos laborales. Una visión sistemática de un riesgo siempre presente realizada por un especialista altamente experimentado.
Brokerage session: expertise
Title: LEITAIT: offering expertise in treatment, reutilization, valorization and sanitation
Presented by Joan Roig, LEITAT
The SMART-NANO project has enabled the development of an innovative and cost-effective technology platform that provides a complete "sample-to-result" solution for the detection, identification and measurement of nanoparticles designed in a wide range of matrices.
BLAZQUEZ, María. Nuevas soluciones para la evaluación de los riesgos de los nanomateriales sectores tradicionales Proyecto LIFE SIRENA. Burjassot: INVASSAT. 04.12.2014. 44 p. 10,54 MB.
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...Merck Life Sciences
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.merckmillipore.com/webinars
Webinar: Closed Sampling, a Critical Component for Every Risk Mitigation Stra...MilliporeSigma
Participate in the interactive webinar now: http://bit.ly/ClosedSamplingWebinar
Sampling should never put your process or sample at risk of contamination resulting in loss of time, money or regulatory scrutiny. This webinar discusses simple and effective sampling options to implement a secure sampling operation across your entire process driving towards closed manufacturing.
Explore our webinar library: www.emdmillipore.com/webinars
Problem formulation for environmental risk assessment in the context of EC Re...OECD Environment
The seminar on Problem Formulation for the Risk Assessment of Biopesticides stemmed from a previous CRP-sponsored event on Innovating Microbial Pesticide Testing that identified the need for an overarching guidance document to determine when in vivo tests are necessary. Problem Formulation, a common practice in pesticide risk assessment, was highlighted as a useful approach for addressing uncertainties in data requirements for biopesticides.
The seminar featured presentations from various perspectives, including industry, regulatory bodies, and academia. Topics included the history and principles of Problem Formulation, industry perspectives on Problem Formulation and how it is applied internally for microbial pesticides, regulatory approaches, and specific case studies. The seminar provided an overview of the challenges, considerations, and potential solutions in harmonising Problem Formulation for biopesticide risk assessment. It emphasised the need for collaboration and discussion to develop Problem Formulation guidance for biopesticides.
BRINGING INNOVATION AND SUSTAINABILITY ALONG THE WHOLE VALUE CHAIN IN THE MED...ICARDA
Tunis, 6-7 November 2019. Training workshop PRIMA – Partnership for Research and Innovation in the Mediterranean Area is the most ambitious joint programme to be undertaken in the frame of Euro-Mediterranean cooperation.
Presentation by Prof. M. Hachicha National Research Institute in Rural Engineering, Water and Forestry, University of Carthage | UCAR
Bertin Technologies has an unique offer covering the whole innovation cycle: it designs and supplies high added-value equipment and software as well as it provides consultancy and engineering services.
Passion for innovation, industrial expertise and intellectual agility to meet demanding customers' needs are the core of Bertin Technologies' DNA.
Have a look at Bertin Technologies' major accomplishments in 2014 :
In 2014, we conducted major research and development in the field of energy efficiency, related to absorption heat pumps. This initiative allowed CNIM to acquire and successfully promote a new range of equipment and services in this area.
In a fast moving IT market, we provided specific solutions for cyber security and big data multimedia content processing.
Drawing on our success in the field of lab equipment as well as chemical, biological and nuclear detection, Bertin went one step further in late 2014 with the acquisition of Saphymo, a leading French provider of solutions for detecting and measuring ionizing radiation. As a result, Bertin has become a key player in the field of scientific instrumentation for defense, nuclear, environment and life science sectors.
Last but not least, by incorporating the Johnson & Johnson Santé Beauté R&D site near Bordeaux in early 2014, our subsidiary Bertin Pharma, has unquestionably positioned itself on the growing market of R&D services for OTC, over-the-counter drugs.
CNIM and Bertin, both deeply inspired, are moving forward together on the forefront of industrial innovation.
Presentación incluida en la Jornada técnica: Campaña de sensibilización Tu vida sin vuelcos, realizada el 16 de diciembre de 2022 por el Centre Territorial de Seguretat i Salut en el Treball (INVASSAT) de Castellón.
Presentación incluida en la Jornada técnica: Campaña de sensibilización Tu vida sin vuelcos, realizada el 24 de novembre de 2022 en el Centre Territorial de Seguretat i Salut en el Treball (INVASSAT) de Valencia
Presentación incluida en la Jornada técnica: Campaña de sensibilización Tu vida sin vuelcos, realizada el 25 de novembre de 2022 en el Centre Territorial de Seguretat i Salut en el Treball (INVASSAT) de Valencia
Presentación incluida en la Jornada técnica: Campaña de sensibilización Tu vida sin vuelcos, realizada el 25 de novembre de 2022 en el Centre Territorial de Seguretat i Salut en el Treball (INVASSAT) de Valencia
Presentación incluida en la Jornada técnica: Campaña de sensibilización Tu vida sin vuelcos, realizada el 10 de novembre de 2022 en el Centre Territorial de Seguretat i Salut en el Treball (INVASSAT) de Alicante
Presentada en el MosIP. Muestra de Innovación en Prevención. Construcción 2022. Organizado por la Fundación Laboral de la Construcción, Comunidad Valenciana. (Bétera, València, 25 y 26 de Octubre)
Presentada en el MosIP. Muestra de Innovación en Prevención. Construcción 2022. Organizado por la Fundación Laboral de la Construcción, Comunidad Valenciana. (Bétera, València, 25 y 26 de Octubre)
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
FITO LÓPEZ, CARLOS (2015). CASES STUDIES: APPLICATION OF THE WEB BASED TOOLKIT TO ASSESS THE RISK IN A SiO2 MANUFACTURING COMPANY
1. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
Cases studies: Application of the Web
Based toolkit to assess the risk in a
SiO2 manufacturing company
Carlos Fito López – Project Coordinator
Head of the Safety Unit & Nanosafety Group Leader
cfito@itene.com
Nanoforum
Milan / September , 2015
REACHnano is partly funded by the European Commission
Life+ with grant agreement LIFE11 ENV/ES/549
4. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
1. Scope and activies covered in the case study
Activities covered
REACHnano - Development of a Web Based toolkit to support the Chemical Safety
Assessment of Nanomaterials
The following activities were considered:
• Exposure Scenario name: Semi-Automated Bagging
• Contributing scenario: Bag filling
• Powder form
• Exposure time: 4 h
• Quantity used: 550 kg
• Exposure controls: PPE + Local Exhaustive Ventilation
• Nº of workers exposed: 2
• Dustiness level: medium (Nanogenotox)
• Process: transfer of the NPs to 25 kg sacks
• Administrative procedures implemented
Case 1. Industrial scale facilities – Sack filling (25 kg)
5. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
1. Scope and activies covered in the case study
Activities covered
REACHnano - Development of a Web Based toolkit to support the Chemical Safety
Assessment of Nanomaterials
The following activities were considered:
• Exposure Scenario name: Mixing in closed systems
• Contributing scenario: Filling / Harvesting
• Powder form
• Exposure time: 5 min
• Quantity used: 5 kg
• Exposure controls: PPE + General ventilation
• Nº of workers exposed: 3
• Dustiness level: medium (Nanogenotox)
• Process: transfer of the NPs to 5 Kg sacks
• Administrative procedures implemented
Case 2. Pilot scale facilities – Mixing operations (5 kg)
6. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
The company studied deals with R&D, production,
engineering and selling of new nanostructured
materials for the mechanical, automotive, ceramics,
glass, chemical, textile, aeronautical, plastic
material and composite material and polymer
industries, and everything connected with these
industries.
Company information and scope of the study
1. Scope and activies covered in the case studies
REACHnano - Development of a Web Based toolkit to support the Chemical Safety
Assessment of Nanomaterials
The case study developed focused on
the quantitative evaluation of the
exposure to airborne ENPs at laboratory
scale-
The case study work on the
characterization of the occupational
exposure to TiO2 during a
functionalization process.
12. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
Analysis of measured data
2. Application of the Risk Assessment Module
REACHnano - Development of a Web Based toolkit to support the Chemical Safety
Assessment of Nanomaterials
• Concentrations levels > 20.000 pt/cm3
• Mass concentration (OPS): 0.1 – 0.5 mg/cm3
• Estimated levels: 0.045 mg/cm3
• Correlation accepted
16. Confidential.OnlyforinternaluseofCompany
Business,Science&Innovation
Analysis of measured data
2. Application of the Risk Assessment Module
REACHnano - Development of a Web Based toolkit to support the Chemical Safety
Assessment of Nanomaterials
• Concentrations levels > 20.000 pt/cm3
• Mass concentration (OPS): 0.05 mg/cm3
• Estimated levels: 0.008 mg/cm3
• Correlation accepted