Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
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.
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...Merck Life Sciences
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
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.
When Coating runs smoothly: Enhance your Coating Process with a new Particle ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3bJypPv
Tablet coating simplified. Finding the perfect coating for your formulation can be challenging. A particle engineered polyvinyl alcohol helps you to optimize your process while maintaining full flexibility in designing the right coating formulation at the right time.
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.
The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.
In this webinar, you will learn:
• How to create your coating formulation by utilizing a broad excipient toolbox
• Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
• Creating the perfect surface finishing
• How to utilize novel analytical technologies to boost your formulation development
EU GMP Annex 1 – Implications on Filtration and Single Use Technology by Soma...MilliporeSigma
What are the major drivers for the new Annex 1? Join us to know more about implications for Filters & Single Use.
In this webinar, you will learn:
• Closed Processing and Single Use Technology implementation
• Points to consider using Single Use Technology
• Sterile Filtration
The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholder from selected industry organisations. The current Annex 1 draft emphasises Contamination Control Strategy (CCS) multiple times and as a key consideration.
Participate in the full, interactive on-demand webinar here: https://bit.ly/ProcessValWebinar
Process validation is a complex step in the transition to commercial scale manufacturing. While Quality By Design (QBD) is the standard option for a risk-mitigating process validation strategy, there are other options for more flexibility and speed. Join our webinar to learn how outsourcing to a CDMO, able to take an adaptive, risk-based validation approach, will accelerate your time to market.
In this webinar, you will discover more about:
• How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
• How a risk-based approach can help you optimize your process validation strategy
• How we have implemented a risk-based approach for our clients via case studies
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdf
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Next Generation Bioprocessing adoption for mAbs – BioContinuum™ Platform Info...Merck Life Sciences
Learn more on the opportunities and hurdles of intensified, connected or continuous processing. 30 US and European biomanufacturers were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’.
Discover the animated version! http://www.merckmillipore.com/INTL/en/20180329_155610?bd=1&tab=2
Visit the BioContinuum™ Platform webpage now! http://www.merckmillipore.com/biocontinuum
Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and ...MilliporeSigma
Register for the interactive, on-demand webinar now: https://bit.ly/USP665
Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.
Since the USP <665> highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP <665> is implemented.
In this webinar, we will discuss:
- Regulatory expectations of extractables and leachables assessment today and tomorrow
- The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing
Using Single-use Technology to Overcome the Challenges of ADC ProcessingMerck Life Sciences
Participate in the interactive webinar: http://bit.ly/SU-ADCWebinar
Challenges of ADC manufacturing can be tackled by adopting single-use technology. Solutions will be presented about how to overcome concerns and implement a processing platform, supported through a strong vendor-manufacturer relationship.
Explore our webinar library: www.merckmillipore.com/webinars
The Emprove® Program: Introduction of New Portfolio AdditionsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3wT5Irt
The Emprove® Program is constantly expanding and updating. Find out about the recently launched Emprove® CCM category for our cell culture media portfolio, the new Emprove® API Information Packages, and the latest updates on available TUPPs for our Emprove® Chemicals portfolio.
This virtual user group will introduce the two latest additions to the Emprove® Program:
1. Our latest category Emprove® CCM for our cell culture media with wave 1 focus on our Cellvento® CHO cell culture media portfolio, looking also into the content of our three Emprove® Dossiers.
2. The new Emprove® API Information Packages that are currently created for our Emprove® APIs, looking into the content and showing how to access.
Additionally, we'll give an overview of latest Technically Unavoidable Particle Profiles (TUPPs) for our Emprove® Chemicals.
In this virtual user group, you will learn:
• Emprove® CCM and its documentation for our cell culture media
• Content and availability of the new Emprove® API Information Package
• Update on available TUPPs for our Emprove® Chemicals
EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter ValidationMilliporeSigma
Watch the presentation of this webinar here: https://bit.ly/3kk0Qs1
In this webinar, you will learn:
- About the GMP Annex 1 draft regulatory overview
- How to incorporate the integrity testing & PUPSIT in the filtration systems validation
- How to design a bacterial retention test in terms of organism selection and single vs multiple use validation
Detailed description:
In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.
Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Process equipment characterization – how standardized extractables data suppo...Merck Life Sciences
View the recording here: https://bit.ly/35KIwBb
Biopharmaceutical Industry recently increased adoption of Single-Use systems and components in manufacturing process operations. Drug manufacturers are responsible for the characterization of SU components and systems used for the production to ensure patient safety. SUS Suppliers are encouraged by BPOG and BPSA to provide comprehensive extractables data package to support drug manufacturer’s E&L assessments.
This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer.
Webinar: Post Approval Changes in Biologics Manufacturing - A Practical Asses...MilliporeSigma
Participate in the interactive webinar: http://bit.ly/PACWebinar
Post-approval changes for biologics manufacturing processes are complicated and challenging with the current global diverse regulatory environment. Here, we will present approaches to make these changes more efficient using a risk-based approach.
Explore our webinar library: www.emdmillipore.com/webinars
Aseptic Process Sampling to address Risk of Contamination & Containment in co...MilliporeSigma
Watch this webinar here: bit.ly/asepticwebinar2020
In this webinar, you will learn:
- The challenges tied to contamination control within a biopharmaceutical environment.
- What closed processing is, and how sampling solutions are an integral component towards that end.
- Advantages of sterile sampling from both a technical and economical viewpoint; with the review of a technical study confirming contamination risk reduction and total cost of ownership.
- Recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling.
Detailed description:
Biopharmaceutical manufacturers are required to ensure drug product quality attributes for patient safety. Strong contamination control strategies should be considered early in process design, and have direct influence on the production environment and equipment selection.
Sampling at each step is a critical component in maintaining a contamination control strategy. Regulators are critical in the sampling process, as it predicts the state of the product or process, and needs to be Representative. A case study will be presented that demonstrates a closed, robust sampling solution capable of maintaining a sterile flow path when challenged with Brevundimonas diminuta. The sampling option you select can help support your goal in achieving a closed process, improving your risk mitigation strategy and product safety.
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
Strategic Considerations for Implementing Single-Use Technologies in Vaccine ...Dr. Priyabrata Pattnaik
Presented at DCVMN 15th Annual General Meeting, 27-October-2014 to 29-October-2014. New Delhi, India. The presentation can be downloaded from the following site.
http://www.dcvmn.org/sites/default/private_files/files/Strategic%20Considerations%20for%20Implementing%20of%20SU%20(Pattnaik).pdf
Single-Use Tangential Flow Filtration for Closed ProcessingMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3b7vD60
Closed processing involves use of physical barriers to separate processing fluid from the external environment. This approach reduces capital expenditures and clean room classification while accelerating time to market. This webinar will present a TFF process run in a closed mode.
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.
In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.
In this webinar, you will learn:
• The context of closed processing
• Differences between closed and functionally closed processing
• The drivers for adoption
• Its practical implementation to a TFF step
Исследование регуляторной среды Беларуси с точки зрения мнения пред-
принимателей об основных проблемах и административно-законодательных
препятствиях в развитии частного бизнеса в стране показало наличие многих
проблем. Руководители малых и средних предприятий (МСП), участвовавшие в
исследовании, отмечают нестабильность и противоречивость законодательства
при большом количестве проверяющих органов и неадекватных нарушениям
наказаниях, правовую «зарегулированность», несовершенную налоговую сис-
тему, большой документооборот и т.д.
Высокая регуляторная нагрузка приводит к высоким прямым и косвенным,
формальным и неформальным издержкам и сдерживает развитие предпринима-
тельства в стране. При этом, как показывает анализ, лишь каждое пятое
предприятие стремится следовать всем требованиям регуляторной среды, тогда
как все остальные выбирают различные формы противодействия. Искажения в
регуляторной среде формируют искажения в поведении и формируют устойчи-
вые стереотипы в умах предпринимателях — «правовое диссидентство и
нигилизм», стремление искать пути обхода существующих правил игры, нега-
тивное отношение к государству и его институтам.
В тоже время развитие частного сектора может стать важным источником
роста белорусской экономики, абсорбировать высвобождающуюся вследствие
реструктуризации крупных предприятий рабочую силу, сглаживать остроту со-
циальных проблем и увеличить поступления в бюджет. Однако для поддержки и
стимулирования развития МСП в стране правительство должно ликвидировать
как идеологические установки в отношении развития предпринимательства в
стране, так
Some thoughts on asynchrony in a modern world, inspired by Reactive Extensions and await in C#, for the Obj-C audience at CocoaHeads Stockholm June 2012.
Please read the notes on each slide to make sense of them, the slides are not understandable by themselves.
Getting your CV noticed by potential employers or recruiters is a tough task, quite simply due to the increased competition today. With hundreds of personal profiles passing their desks each day, make sure yours isn't the one that's riddled with mistakes. Take a look at this visual outlining 10 CV mistakes to avoid.
Challenges using Multiple Single-use Systems: Functionality versus Extractabl...MilliporeSigma
As single-use technologies continue to expand in pharmaceutical manufacturing processes, the risk assessment for extractables and leachables becomes increasingly complex. Join this webinar to obtain guidance on how to perform risk evaluation on a process with multiple single-use components.
A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps-- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.
This webinar will evaluate the different single-use components with respect to compatibility and extractables and leachables. A case study will be used to demonstrate the complexity and potential concerns when performing a risk evaluation on the manufacturing process.
In this webinar, you will learn:
- Risk assessment of extractables
- Single-use component evaluation
- Complexity when evaluating multiple assemblies
Tannic Acid Manufacturing Plant Project Report.pptxSmith Anderson
The report provides a complete roadmap for setting up an Tannic Acid. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
Canned Vegetables Manufacturing Plant Project Report.pptxSmith Anderson
The report provides a complete roadmap for setting up an Canned Vegetables. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
pilot plant is a small system which is operated to find out about the behavior of a process before using it on a large industrial scale. so, this presentation tries to illustrate its objective and significance to understand the methodologies of various pharmaceutical dosage forms.
Presented at length on 23 April and 21 May 2017 at ICCBS, HEJ and Getz Pharma Auditorium, Karachi in a Discussion Forum of about 800 practicing university qualified professionals of various pharmaceutical manufacturing industries
The report provides a complete roadmap for setting up a Organic Fertilizer Manufacturing Plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
The report provides a complete roadmap for setting up a Dodecanoic Acid Manufacturing Plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
The report provides a complete roadmap for setting up a sanitizer manufacturing plant. It covers a comprehensive market overview to micro-level information such as unit operations involved, raw material requirements, utility requirements, infrastructure requirements, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, etc.
SPLC 2018 Summit: Making the Business Case: Measuring the Economic Outcomes o...SPLCouncil
Slides from Jenna Larkin, Environmental Protection Specialist, U.S. Environmental Protection Agency, presented at the Sustainable Purchasing Leadership Council's 2018 Summit in Minneapolis, MN.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
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Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
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👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
The Metaverse and AI: how can decision-makers harness the Metaverse for their...Jen Stirrup
The Metaverse is popularized in science fiction, and now it is becoming closer to being a part of our daily lives through the use of social media and shopping companies. How can businesses survive in a world where Artificial Intelligence is becoming the present as well as the future of technology, and how does the Metaverse fit into business strategy when futurist ideas are developing into reality at accelerated rates? How do we do this when our data isn't up to scratch? How can we move towards success with our data so we are set up for the Metaverse when it arrives?
How can you help your company evolve, adapt, and succeed using Artificial Intelligence and the Metaverse to stay ahead of the competition? What are the potential issues, complications, and benefits that these technologies could bring to us and our organizations? In this session, Jen Stirrup will explain how to start thinking about these technologies as an organisation.
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
One such alternative that has garnered significant attention and acclaim is Nitrux Linux 3.5.0, a sleek, powerful, and user-friendly Linux distribution that promises to redefine the way we interact with our devices. With its focus on performance, security, and customization, Nitrux Linux presents a compelling case for those seeking to break free from the constraints of proprietary software and embrace the freedom and flexibility of open-source computing.
Generative AI Deep Dive: Advancing from Proof of Concept to ProductionAggregage
Join Maher Hanafi, VP of Engineering at Betterworks, in this new session where he'll share a practical framework to transform Gen AI prototypes into impactful products! He'll delve into the complexities of data collection and management, model selection and optimization, and ensuring security, scalability, and responsible use.
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https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
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Paper: https://eprint.iacr.org/2023/1886
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My slides at Nordic Testing Days 6.6.2024
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Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...James Anderson
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The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
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- These are slides of the talk given at IEEE International Conference on Software Testing Verification and Validation Workshop, ICSTW 2022.
Welcome to the first live UiPath Community Day Dubai! Join us for this unique occasion to meet our local and global UiPath Community and leaders. You will get a full view of the MEA region's automation landscape and the AI Powered automation technology capabilities of UiPath. Also, hosted by our local partners Marc Ellis, you will enjoy a half-day packed with industry insights and automation peers networking.
📕 Curious on our agenda? Wait no more!
10:00 Welcome note - UiPath Community in Dubai
Lovely Sinha, UiPath Community Chapter Leader, UiPath MVPx3, Hyper-automation Consultant, First Abu Dhabi Bank
10:20 A UiPath cross-region MEA overview
Ashraf El Zarka, VP and Managing Director MEA, UiPath
10:35: Customer Success Journey
Deepthi Deepak, Head of Intelligent Automation CoE, First Abu Dhabi Bank
11:15 The UiPath approach to GenAI with our three principles: improve accuracy, supercharge productivity, and automate more
Boris Krumrey, Global VP, Automation Innovation, UiPath
12:15 To discover how Marc Ellis leverages tech-driven solutions in recruitment and managed services.
Brendan Lingam, Director of Sales and Business Development, Marc Ellis
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf91mobiles
91mobiles recently conducted a Smart TV Buyer Insights Survey in which we asked over 3,000 respondents about the TV they own, aspects they look at on a new TV, and their TV buying preferences.
Smart TV Buyer Insights Survey 2024 by 91mobiles.pdf
Apresentação de Susan Ferenc
1. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
CPDA ADJUVANT CERTIFICATION
PROGRAM AND THE IMPACTS OF
ADJUVANTS ON ACTIVE INGREDIENT
RESIDUES ON FOOD
Agricultural Adjuvants in Brazil
December 9, 2013
Brasilia, Brazil
2. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Why Build a Program?
• Late 60s through mid 80s
– Predominantly a pre-emergence herbicide market
– Adjuvant usage focused on formulations
• Mid to late 80s to current
– Transition to post emergence herbicides
– Explosion in the need for adjuvants to enhance
herbicide performance
3. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Late 80s - CPDA Addresses Issue
•
•
•
•
Adjuvants not registered like pesticides
Limited use of standardized definitions
Undefined product functionality claims
Failure of some products to correctly warn of safety
and handling issues
• Inconsistent composition
• Variable performance
• Use of incorrect products or use rates
4. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
The Consequences!
• Consumer confusion / frustration
• Open to increased regulatory scrutiny
• Certain states began to develop adjuvant
regulations
• CPDA – let’s get pro-active and develop
Adjuvant Standards
5. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvants Commonly Used in
Agriculture
• Adjuvants used to support biological efficacy
Surfactants (non-ionic surfactant – NIS, ionic, blends)
o Penetrating agents, dispersing and emulsifying agents
Oils (modified seed oil – MSO; crop oil concentrate – COC)
o Petroleum, vegetable, paraffinic & combinations; aid penetration of plant
cuticle, reduce evaporation, reduce surface tension
• Utility adjuvants used for other purposes
Water conditioning, softening or buffering agents
Foam control agents
6. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards:
Concepts and Principles
(1) Voluntary and self-certifying program
(2) Benefit end-users and pesticide manufacturers
(3) Encourage pesticide manufacturers to promote and
recommend CPDA Certified Adjuvants
(4) Adjuvant manufacturers must promote the value of
Certified Adjuvants to consumers
7. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards:
Concepts and Principles
(5) Initial Certification activities were focused on
developing standards and guidelines for labels
(6) ASTM was utilized as the source for standardized
definitions and, when available, test methods to
document functionality claims in the Certification
Program
8. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
History of ASTM / CPDA Adjuvant Standardization
1987
ASTM E-35
Call for Adj.
Term Std.
1999
Dvp. & review
of Certification
License
2000
April 15
Deadline for
Comments
1990
ASTM E-35
Adj. Terms
Task Force
1998
Legal and
Board review
of Program
1991
Founding of the
CPDA AIC
1997
Development
of Std. (S-1) –
(S-17)
Certification
Standards
& Guidelines
Adopted July 2000
(S-1) - (S-17)
1993-95
ASTM-E-35
E-1519-95
Adj. Terms
1996
First Adjuvant
Std. Meeting
9. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Benefits of CPDA / ASTM
Adjuvant Standardization Efforts
• The standardization of more than 70 terms
• Development of standardized methods for: Tank Mix
Compatibility, Nonvolatile Matter of Agricultural
Adjuvant Solutions by Thermogravimetry,
Agricultural Acidifiers, Effectiveness of Foam Control
Agents, Relative Extensional Viscosity of Agricultural
Spray Mixes.
• Developing methods for: Water Conditioning Agents,
Drift Reduction, Humectancy
10. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Adjuvant Standards
• The adjuvant standards were intended to:
Establish minimum guidelines for good product stewardship
Establish use of EPA approved inerts in adjuvant formulations
Establish good product communication guidelines (MSDS, product labeling, and
hazard identification)
Support product functionality claims by meeting ASTM definitions for function
Give end user useful information so they can make an informed choice
• The adjuvant standards were not intended to:
x
x
x
Establish efficacy or regulate the claims made by the manufacturer
Provide for extensive toxicology (hazard and environmental) testing
Differentiate products in the marketplace between acceptable and not
acceptable
11. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Standards are based on ….
•
•
•
•
•
Regulatory and function guarantees (S1-S3)
Safety (S4 - S7)
Testing guidelines (S8 - S10)
Methodology and labeling (S11 - S15)
Product stewardship (S16 - S17)
12. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Council of Producers & Distributors of
Agrotechnology
Labeling and Performance Standards for Spray
Adjuvants and Soil Conditioners
13. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Product name
– Primary license
– Sub-license
• If sub-license – list name of primary product being sub-licensed
• Product type (NIS, COC, etc.) must be defined in
ASTM E-1519 or E-609
• Submit copy of current label
14. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Submit summary of toxicity studies
– Dermal, oral and eye irritation mandatory
– LD-50 in each category required
• Submit MSDS
• Complete company information
• Sub-license – List name and address of sub-licensee
as it appears on the label
15. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Are functionality claims defined in ASTM E-1519 or E609? – They must be!
• Were ASTM standardized methods used?
• Is it labeled for use on food crops?
• Are the components listed in CFR 40, 180?
• Is the packaging Department of Transportation
compliant?
DOT Compliant Packaging
16. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Does it contain OSHA Regulated Hazardous
Materials?
– If yes, then toxicity studies for inhalation, dermal irritation
and skin sensitization are required.
• Does it list 24 hour data service?
• Are precautionary statements included?
• Is the designation of the proper product hazard
signal word included?
17. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Are aquatic uses on label?
- If yes, then a summary of the aquatic toxicity study is
required
• Do active ingredients contribute to one or more of
the functions defined in ASTM E-1519 of E-609?
• Does it list the % surfactant guarantee?
18. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process
• Are components water dispersible and do they
reduce surface tension of water per ASTM Method
D-1331?
• Are types of oil (if two or more) listed in descending
order?
• Is the unsulphonated oil residue (UR) value listed?
• Are state labels identical with respect to all
applicable Certification Standards?
19. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Certification Process:
Completion
• Applicant advised of approval
• Sign licensing agreement and submit Certification of
Compliance
• Pay appropriate fee
• Re-certify every 3 years
20. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
EPA Action
In 2006, EPA approved the following language to be placed on a
registered pesticide product:
“When an adjuvant is to be used with this product,
[name of the registrant of the pesticide] recommends
the use of a Council of Producers & Distributors of
Agrotechnology certified adjuvant.”
21. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Effects of Adjuvants on Active
Ingredient Residues
• EPA Guideline 860.1500: “If the label of a product
recommends addition of another ingredient such as
crop oil or a specific class of surfactants, the field
trials should reflect the use of that additive.”
• In 2008, EPA began selectively requiring adjuvant
prohibition statements on pesticide product labels if
adjuvants were not included in the residue trials.
23. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Industry Dataset
• CPDA and CropLife America member companies provided
residue trial results to examine the effect of adjuvants on
residue levels
• 1800+ residue data points were collected and coded
• Data covers fungicides, insecticides, herbicides; 25 active
ingredients; multiple crops; predominantly oils and
surfactants; data from NAFTA countries and Europe
• 437 side-by-side comparisons of “with adjuvant/without
adjuvant” were selected for initial industry analysis
24. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Industry Analysis:
• Ratios of “residue with adjuvant/residue without adjuvant”
were generated
• Statistical analysis was done to examine the effects by:
adjuvant type; active ingredient type (fungicide, insecticide,
herbicide); and crop
• Found that 75% of “adjuvant:no adjuvant” ratios were <1.4
• In general, neither adjuvant type nor active ingredient type
influenced ratios
• Range of variability seen is typical of residue data
25. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Next Steps
• Dataset submitted to EPA for further analysis
• EPA resources insufficient to conduct a full statistical analysis
• CPDA and EPA developed a statistical analysis plan and CPDA
commissioned Dr. George Casella, University of Florida to conduct
the analysis
~ Is there an overall effect of adjuvants on the active ingredient residue
level?
~ Is the adjuvant effect the same for all crops?
~ If there is a crop effect, is the overall adjuvant by crop interaction less than
the adjuvant effect?
~ If there is an effect of adjuvant, is there a difference between adjuvant
types?
26. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
N
original
row
number
Country
ASTM Category
CROP TYPE
1
2
3
4
5
6
7
8
9
10
11
12
1
2
3
4
13
14
15
16
17
18
19
20
21
22
23
24
25
262
264
266
274
276
278
268
270
272
280
282
284
212
217
210
215
1744
1746
1304.1
1305
1306
1307
1316.1
1317
1318
1319
1333.05
1333.06
1333.07
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
US
US
US
US
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
EU
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Oil
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Surfactant
Alfalfa green matter
Alfalfa green matter
Alfalfa green matter
Alfalfa green matter
Alfalfa green matter
Alfalfa green matter
Alfalfa hay
Alfalfa hay
Alfalfa hay
Alfalfa hay
Alfalfa hay
Alfalfa hay
Almond hull
Almond hull
Almond nutmeat
Almond nutmeat
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Barley grain
Residues
Residues
with
w/o adjuvant
adjuvant
0.09
0.02
0.02
5.39
0.17
0.25
0.14
0.02
0.02
3.54
0.69
0.73
2.893
1.447
0.041
0.033
3.751
6.012
3.8
5.5
6.7
12
2.2
2.0
4.1
7.3
1.7
4.5
4.9
0.03
0.02
0.02
1.42
0.2
0.43
0.06
0.02
0.02
1.33
0.6
0.71
3.947
2.103
0.038
0.014
2.624
3.098
3.6
6.3
9.7
13
1.5
1.6
2.6
6.5
1.7
3.2
4.9
27. FDA DATA ON ESTABLISHED TOLERANCE VIOLATIONS
Year
Category
Total Samples
Violations
2008
TOTAL
1,398
0
2007
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
143
28
45
403
672
26
1,317
0
0
0
0
5
0
5
2004
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
326
49
123
868
1,383
83
2,832
301
49
95
822
1,316
55
2,638
226
21
35
372
711
29
1,394
0
0
0
1
3
0
4
0
0
0
3
2
0
5
0
0
0
1
3
0
4
2000-2008
TOTAL
18,671
40
2006
2005
Year
Category
Total Samples
Violations
2003
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
154
21
122
813
1,132
102
2,344
0
0
0
0
1
8
9
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
Grains & Grain Products
Milk/Dairy/Eggs
Fish/Shellfish
Fruit
Vegetables
Other
TOTAL
282
25
117
725
895
78
2,122
286
33
114
710
888
70
2,101
268
65
138
978
986
90
2,525
0
0
0
0
0
0
0
1
0
0
3
7
0
11
0
0
0
1
1
0
2
2002
2001
2000
28. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Conclusions
• Casella: “There is no statistically significant effect of adjuvants
on pesticide residue levels.”
• CPDA: During a 9-year period “there were only 40 tolerance
exceedence violations out of 18,671 samples tested” and
“there was no identifiable trend associated with crop type or
active ingredient.”
• EPA Health and Effects Division: “HED has examined industry’s
analysis of the effect of adjuvants on pesticide residues and
has come to the conclusion that existing tolerances and risk
assessments will be adequate and protective of public health,
even if special field trials involving adjuvant use were not
conducted.”
29. COUNCIL OF PRODUCERS &
DISTRIBUTORS OF AGROTECHNOLOGY
Thank you!
Visit www.cpda.com