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Nelson Labs
Добавлен 20 май 2011
Nelson Labs, a Sotera Health company, is an industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
With the addition of Nelson Labs Europe, we are a leading global extractables and leachables lab testing platform. We have over 500 scientists, technicians, and service specialists who diligently performing more than 800 rigorous tests in 14 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.
Visit www.nelsonlabs.com
Follow Us:
Blog: www.nelsonmedtechinsights.com
LinkedIn: www.linkedin.com/company/nelson-laboratories-llc
Twitter: NelsonLabs
With the addition of Nelson Labs Europe, we are a leading global extractables and leachables lab testing platform. We have over 500 scientists, technicians, and service specialists who diligently performing more than 800 rigorous tests in 14 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.
Visit www.nelsonlabs.com
Follow Us:
Blog: www.nelsonmedtechinsights.com
LinkedIn: www.linkedin.com/company/nelson-laboratories-llc
Twitter: NelsonLabs
History & Modern Practices for ASTM E1174: Evaluating the Effectiveness of Handwash Formulations
ASTM E1174 was first developed in 1987 and was developed to evaluate Healthcare Personnel Handwash Formulations (HCPHW) first defined by the FDA in 1978. The method and regulations have undergone several changes and modifications over the decades with the most recent version of the ASTM method being released in 2021 and the FDA publishing the final monograph in 2017. This webinar will provide a historical overview of the procedures used to evaluate HCPHW and an in-depth presentation of the procedures in the current method and regulation as well as considerations that must be made when performing such evaluation.
What You Will Learn:
- The historical development of ASTM E1174 and FDA regulat...
What You Will Learn:
- The historical development of ASTM E1174 and FDA regulat...
Просмотров: 69
Видео
DAY 3 - Toxicological Considerations of VH2O2 Sterilization Residuals
Просмотров 12614 дней назад
VH2O2 sterilization may leave hydrogen peroxide residuals on the device materials after the sterilization process whose toxicological risk must be evaluated (in addition to evaluating the device’s biocompatibility). ISO 22441 simply states that these limits shall be based on a health-based risk assessment per ISO 10993-17, which outlines expectations for the toxicological risk assessment of med...
DAY 2 - Considerations for Biocompatibility
Просмотров 5414 дней назад
Biocompatibility assessments involve extensive evaluation, and changing the sterilization modality, such as to VH2O2, can trigger considerable, new resource-intensive testing. The session will highlight collaborative efforts between the FDA and industry to develop a tool to streamline evaluations. At present, however there are still ways to streamline the impact of switching to VH2O2. We will d...
DAY 1 - VH2O2, Sterilization Considerations
Просмотров 6314 дней назад
VH2O2 has been a common sterilization option for reusable devices for many years. Interest has increased for single-use device. The publication of ISO 22441:2022 and its recognition by the US FDA - coupled with the FDA’s 2024 reclassification of VH2O2 sterilization as an Established Category A process in 2024 - support this modality of sterilization. Each sterilization modality has its limitati...
Intro E&L- and Safety Considerations for Disposable Biopharmaceutical Manufacturing Equipment.
Просмотров 4928 дней назад
Introduction to the Nelson Labs Leuven Open House in March 2024 by Erik Meyers. Presentation of Sotera Health and its Business Units. Focus of the symposium;: Extractables & Leachables (E&L) - and Safety Considerations for Disposable Biopharmaceutical Manufacturing Equipment. Eric Meyers, Senior Vice President EMEAA - Nelson Labs
How QMS Impacts Quality Maturity
Просмотров 91Месяц назад
Join us for an interactive session with Susan Schniepp exploring various strategies behind quality maturity. You’ll learn about regulation changes & how each can impact your team’s success. A real time audience discussion will close the session and challenge your thinking about audit scenarios.
Handling Unexpected Biocompatibility Test Results in Medical Device Development
Просмотров 83Месяц назад
Getting unexpected or failing test results for any biocompatibility test can feel like the end of the line for a medical device. As a vital step in device development, biocompatibility testing has a major effect on the approval process timeline. This 10-minute Tech Talk will shed a light on the bleak consequences of unexpected biocompatibility test results. It will outline several questions des...
The Fight Against Viruses: The Importance of Cleanroom Virus Disinfection Validations
Просмотров 422 месяца назад
Ensuring that cleanroom virucidal disinfectants adequately inactivate viruses is essential for maintaining sterile work environments and reducing the risk of contamination. This webinar will address the principles outlined in ASTM and USP methods for surface disinfection and examine their application in cGMP-compliant pharmaceutical manufacturing settings. Particularly, this webinar will discus...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Просмотров 1262 месяца назад
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety. Throughout recent years there have been multiple fatalities reported due to the presence of these contaminants in drug products. This webinar will cover the testing of high-risk drug components for ethylene glycol and diethylene glycol. This webinar is ideal for Pharma manufacture...
Biocompatibility Testing, What You Need to Know
Просмотров 4213 месяца назад
When it comes to biocompatibility testing on medical devices, there are many aspects that have to be considered not only in determining the applicable tests, but the condition of the samples and how they are prepared for testing. Failure to provide clinically representative samples or sufficient instructions for sample preparation may lead to inaccurate results or test failures that otherwise m...
Advancing Microbial-Contamination Detection Through Rapid Sterility Testing
Просмотров 3384 месяца назад
Increasing industry and product demand for expedited product release reinforces the need to embrace rapid sterility technologies. Nelson Labs is pleased to introduce the implementation of the Celsis® Advance II rapid sterility test platform. This versatile technology allows us to deliver fast, reliable, and compliant sterility-testing results tailored to the unique requirements of your product....
What’s New with Reprocessing Validations for Reusable Medical Devices
Просмотров 6784 месяца назад
There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations of reusable medical devices, such as AAMI ST98:2022 and recent updates to established standards like AAMI TIR12:2020 and ISO 15883-5:2021. It can be difficult to navigate these updates and ensure that your reusable devices have the proper reprocessing validatio...
Disinfectant Efficacy Testing on Site Specific Surfaces
Просмотров 3435 месяцев назад
Disinfection efficacy studies play a significant role in the Pharmaceutical manufacturing environment in ensuring that the surfaces are adequately sanitized through cleaning and disinfection procedures. This helps maintain clean work environments and reduces the potential for microbial contamination. Join our in-detail upcoming live webinar which addresses the common questions asked by pharmace...
Biocompatibility as a Critical Design Input
Просмотров 2775 месяцев назад
Biocompatibility evaluation must accompany any medical device that has contact with a patient during use and is a requirement before a device can be cleared for market. This is usually the last step in device development and should be performed per ISO 10993-1. While biocompatibility should be assessed using the final finished device, it should not be considered as an after-thought, but instead...
Biocompatibility as a Critical Design Input
Просмотров 2336 месяцев назад
Biocompatibility evaluation must accompany any medical device that has contact with a patient during use and is a requirement before a device can be cleared for market. This is usually the last step in device development and should be performed per ISO 10993-1. While biocompatibility should be assessed using the final finished device, it should not be considered as an after-thought, but instead...
How to design an Instruction For Use and validations for EU and US
Просмотров 1646 месяцев назад
How to design an Instruction For Use and validations for EU and US
The Impact of Physico-chemical Properties of Extractable Compounds on Their Analytical Responses
Просмотров 1936 месяцев назад
The Impact of Physico-chemical Properties of Extractable Compounds on Their Analytical Responses
A risk based approach towards the assessment of process equipment related leachables - case study
Просмотров 3107 месяцев назад
A risk based approach towards the assessment of process equipment related leachables - case study
Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers
Просмотров 1908 месяцев назад
Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers
What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1
Просмотров 7829 месяцев назад
What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1
Package Validations - Meeting the Requirements of ISO 11607
Просмотров 1,1 тыс.9 месяцев назад
Package Validations - Meeting the Requirements of ISO 11607
The Impacts of Updated Standards on IFU Validations for Reusable Medical Device
Просмотров 33510 месяцев назад
The Impacts of Updated Standards on IFU Validations for Reusable Medical Device
Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17
Просмотров 1,5 тыс.10 месяцев назад
Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17
Medical Device Chemical Characterization
Просмотров 90610 месяцев назад
Medical Device Chemical Characterization
Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies
Просмотров 14010 месяцев назад
Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies
Perform cleaning validations of reusable medical devices after publication of ANSI_AAMI ST98:2022
Просмотров 34310 месяцев назад
Perform cleaning validations of reusable medical devices after publication of ANSI_AAMI ST98:2022
Packaging related nitrosamines in Drug Products
Просмотров 84011 месяцев назад
Packaging related nitrosamines in Drug Products
Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2
Просмотров 68411 месяцев назад
Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2
What Makes a Successful ISO 18562 Toxicological Risk Assessment?
Просмотров 63911 месяцев назад
What Makes a Successful ISO 18562 Toxicological Risk Assessment?
Biofilm in Health Care Products - Key Considerations in Biofilm Management
Просмотров 203Год назад
Biofilm in Health Care Products - Key Considerations in Biofilm Management
Very informative
I introduce scientific content, pharmaceutical Microbiology kindly check my channel
Is Nelson labs a place I can get testing done on my products?
Great explanation
Love this
Thank you, I'm working on this for my project
Thanks Sir
Very nice presentations and more helpful to pharma companies
*promosm*
I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that RUclips is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that RUclips is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
Hi how have you setup this exposure chamber. Please guide me.
very useful, thank you
According to your initial wordings, if this was to be applied to EUMDR 2017/745 , All the tests mentioned in endpoints chart need to be conducted right?
Great talk
This can't be real
Informative
Thank you for a very informative talk
I want to set up in india
Question: If my company makes only the HDPE bottle, which level of testing am I required to execute? 661.1 or 661.2? Thanks!
The perdiatrics volume is 5 m3 per day
I agree, in a lab setting , disinfectants and sanitizers are very effective against microbes when their toxic levels (dose) could be maintained and delivered. That's a big leap to the real world where the products are used and unfortunately this doesn't always happen in the field and some sanitizers for food contact surfaces provide sub-lethal levels of the residual active ingredients for toxicity reasons whereby the microbes have been shown to adapt. Just look at all the evidence of pseudomonas spp. pumping out QAC's. Also failure to maintain the required contact time set's up conditions for adaptation. Sanitizer test methods claiming 99.9% kill are also NOT representative of real world efficacy because they are tested in solution instead of a real surface or with ASTM 2197. I would give them 30% efficacy in the real world at most and that's equivalent to much less than 1 log.
Is it a risk assessment or equipment operation demonstration
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What is surrogate in extractable leachable?
Nice
Can invitro testing be used as a cheaper screening test? Not for regulatory submission?
This was a very informative video and certainly supports how important it is in following the IFU's.
what's that RUclips video you were trying to show? Can you put the link in the description of this video?
Excellent presentation. Thank you
Great webinar! A question I had: If a packaging lot size of a commercial validated packaging process needs to be increased by 5x, would this require packaging validation on the 5x lot size? What's the requirement in such a case?
thanks for sharing
I attend it live it was awesome and I came here to watch it again particularly Q&A session
How do you make sure you don't contaminate the sterile coupons during the testing process. If you need to lie the coupon flat to apply the target organism on the top how do you keep the bottom sterile so if you are immersing the coupon fully you don't get contamination. How do you achieve that? Thanks
What standard is this being done to? Thanks
I know this is 3 years old, but I do have a question. Let's say that a system extracts fluid from the patient into a bag. What type of contact characterizes parts that are outside the body such as external tubing and bags that collect blood? Thanks!
I think that's indirect contact
@@slz1119 Thank you!
How can I download this presentation hands out ? Thank
Good 👍
Pouvons-nous acheter ce produit ?
Thank you so much for this great service .. this will help many scientists all over world..❤️ from India 🇮🇳
Thank you for such an informative presentation.
very important thank you
Awesome (as always). Great source of information. Thank you for sharing!
so its bad ?
ruclips.net/channel/UCyB3GFq6cWuAZzGWpnTX70A
Great presentation. I laughed too on the Cytotox failures which are driving we engineers insane by proxy!
Can u please video offline mode also clarity to reading
I am down load this video but I am reading time show blurred
The bacterial endotoxin test (BET) is an important part of assuring safety of par enteral pharmaceuticals and medical devices that contact blood or cerebrovascular fluid. Endotoxin (in the form of LPS) is a naturally occurring product of bacterial metabolism, most often shed
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