STERIS Applied Sterilization Technologies
STERIS Applied Sterilization Technologies
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STERIS AST TechTalk | Practical Navigation of the Approaches Contained in ISO 11137-2 and ISO 13004
In this webinar, STERIS Senior Scientist David Ballard and Laboratory Technical Manager Sarah Conway outline how a product’s specific requirements, such as bioburden levels and dosage requirements, can be used to determine the most effective radiation sterilization approach in accordance with ISO standards.
Seminar Overview:
2:30 - Definitions
4:20 - Microbiological Radiation Validation Phases
6:34 - Laboratory Testing Standards
7:00 - Sterilization Dose / Max Dose
8:09 - The Radiation Standards - Approach Options
20:06 - Radiation Validation Approach Selection
37:30 - Key Takeaways
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About Us:
STERIS Applied Sterilization Technologies provides contract sterilization, laboratory testing and validation, product and packaging testing, and technical support services to manufacturers of medical devices, pharmaceuticals, consumer goods, and industrial products.
STERIS Product Testing Services: www.steris-ast.com/product-testing/
STERIS Packaging Testing Services: www.steris-ast.com/packaging-testing/
STERIS Testing & Validation Services: www.steris-ast.com/testing-validation/
Find a Location: www.steris-ast.com/locations/
Contact Us: www.steris-ast.com/contact-us/
Follow STERIS AST:
LinkedIn: www.linkedin.com/company/steris-applied-sterilization-technologies
SUBSCRIBE to our channel for more information on contract sterilization, testing & validation, and technical support services at every stage of the sterilization process.
zhlédnutí: 69

Video

An Overview of Electron Beam Irradiation's Effect on Cannabis | STERIS AST TechTalk17:53An Overview of Electron Beam Irradiation's Effect on Cannabis | STERIS AST TechTalk
An Overview of Electron Beam Irradiation's Effect on Cannabis | STERIS AST TechTalk
zhlédnutí 89Před měsícem
The popularity of cannabis for medicinal and recreational purposes is quickly increasing. In this webinar, learn about the history, healthcare applications, and potential contaminants associated with cannabis, and find out how E-beam irradiation can help you mitigate these risks and ensure patient safety. Led by STERIS Senior Radiation Sterilization Manager Betty Howard, this is a great opportu...
SteriLink® Supply Chain Visibility2:00SteriLink® Supply Chain Visibility
SteriLink® Supply Chain Visibility
zhlédnutí 120Před 2 měsíci
SteriLink is an online, interactive service that provides complete, real-time visibility into STERIS processing facilities*. The SteriLink service is designed to shorten time between manufacturing and distribution by allowing you to: Monitor your inventory, 24/7 Receive alerts Review and retrieve historical processing documents Check performance metrics and generate reports In short, you gain c...
Fundamentals of Mathematical Modeling | STERIS AST TechTalk45:10Fundamentals of Mathematical Modeling | STERIS AST TechTalk
Fundamentals of Mathematical Modeling | STERIS AST TechTalk
zhlédnutí 394Před 6 měsíci
STERIS uses mathematical modeling to simulate and support the radiation validation process. In this TechTalk, Spencer Mickum, Principal Scientist at STERIS AST, details the phases of mathematical modeling, including gathering data, developing a digital model, running the simulation and applying the results. Webinar Overview: 2:30 - Agenda 3:12 - Summary: What Is Mathematical Modeling? 8:52 - Da...
Bacterial Endotoxin Testing in Compliance with ISO 11737-3 Testing Standard | STERIS AST TechTalk38:39Bacterial Endotoxin Testing in Compliance with ISO 11737-3 Testing Standard | STERIS AST TechTalk
Bacterial Endotoxin Testing in Compliance with ISO 11737-3 Testing Standard | STERIS AST TechTalk
zhlédnutí 1KPřed 6 měsíci
The main fever-inducing substances, or pyrogens, found in manufactured health care products are bacterial endotoxins, which means that it is crucial to test for them- both to protect patient safety and to comply with regulatory standards. In this webinar, learn how to utilize bacterial endotoxin testing (BET) while complying with the relevant regulatory requirements (including the new ISO 11737...
Introduction to the Radiation Sterilization Master File Pilot Program | STERIS AST TechTalk30:59Introduction to the Radiation Sterilization Master File Pilot Program | STERIS AST TechTalk
Introduction to the Radiation Sterilization Master File Pilot Program | STERIS AST TechTalk
zhlédnutí 445Před 7 měsíci
STERIS is the first participant in the FDA’s new Radiation Sterilization Master File Pilot Program, which expedites the approval process for refining sterilization methods of single-use medical devices. This improves supply chain adaptability, mitigating potential roadblocks that might otherwise cause a supply chain shortage or hinder innovation. In this seminar, learn eligibility requirements,...
Lab Challenges for Validation of Single-Use Bioprocessing Systems | STERIS AST TechTalk31:32Lab Challenges for Validation of Single-Use Bioprocessing Systems | STERIS AST TechTalk
Lab Challenges for Validation of Single-Use Bioprocessing Systems | STERIS AST TechTalk
zhlédnutí 327Před 10 měsíci
Choosing optimal single-use bioprocessing devices when developing an enhanced test method is crucial, and doing so requires consideration of intricacies such as size, complexity, variability, aseptic technique, microorganism detection, and lab capacity. After giving an overview of microbiological testing for radiation sterilization validation, Jason Rogers, principal scientist at STERIS Applied...
Product & Packaging Testing to Support Medical Devices | STERIS AST TechTalk30:31Product & Packaging Testing to Support Medical Devices | STERIS AST TechTalk
Product & Packaging Testing to Support Medical Devices | STERIS AST TechTalk
zhlédnutí 505Před 10 měsíci
Ensuring that a medical device and its packaging are safe and perform effectively is crucial when guiding product development, regulatory compliance, and marketing efforts. Nate Wilhelm, Packaging Testing Manager at STERIS Applied Sterilization Technologies (AST), outlines essential tests for validating sterility of a medical device’s packaging and explains when to use each test. Then, Phillip ...
Shelf Life Extension For Sterile Medical Devices | STERIS AST TechTalk35:43Shelf Life Extension For Sterile Medical Devices | STERIS AST TechTalk
Shelf Life Extension For Sterile Medical Devices | STERIS AST TechTalk
zhlédnutí 470Před 10 měsíci
STERIS Applied Sterilization Technologies packaging advisor Noel Gibbons discusses how medical device manufacturing companies can safely and effectively extend the shelf life of packaged sterile medical devices and products. With the help of Nate Wilhelm, Product & Package Testing Manager at STERIS, he outlines tests that can be helpful in avoiding the risks of shelf life extension and offers a...
Managing Manufacturing Changes for Radiation Processing | STERIS AST TechTalk47:35Managing Manufacturing Changes for Radiation Processing | STERIS AST TechTalk
Managing Manufacturing Changes for Radiation Processing | STERIS AST TechTalk
zhlédnutí 276Před 10 měsíci
Gain a microbiologist’s perspective on best implementing manufacturing or materials changes without impacting your validated radiation-based sterilization process. - Managing Manufacturing Changes for Radiation Processing Overview: Microbiological testing for radiation sterilization validation - Applicable standards - Review of radiation sterilization validation process - Test method validation...
X-ray Sterilization Processing for Bioprocessing Products | STERIS AST32:09X-ray Sterilization Processing for Bioprocessing Products | STERIS AST
X-ray Sterilization Processing for Bioprocessing Products | STERIS AST
zhlédnutí 663Před rokem
Description: Senior Radiation Sterilization Manager Betty Howard discusses the use of radiation processes for biopharmaceutical products to remove the ambiguity of using X-ray sterilization. Learn about the similarities and differences between X-ray and gamma sterilization and how to choose the radiation modality that is right for your product. X-ray Sterilization with Bioprocessing Products Ov...
Product & Packaging Testing Services in Brooklyn Park, MN | STERIS AST1:36Product & Packaging Testing Services in Brooklyn Park, MN | STERIS AST
Product & Packaging Testing Services in Brooklyn Park, MN | STERIS AST
zhlédnutí 431Před rokem
Get an inside look at the STERIS Product & Packaging Services facility in Brooklyn Park, Minnesota, USA. The expansion of the existing Brooklyn Park laboratory furthers our commitment to supporting our Customers’ needs and global medical device manufacturing. The addition of package testing, transportation testing, and accelerated aging testing provides Customers with a single-source supplier f...
Accelerated Aging & Real Time Studies | STERIS AST TechTalk27:45Accelerated Aging & Real Time Studies | STERIS AST TechTalk
Accelerated Aging & Real Time Studies | STERIS AST TechTalk
zhlédnutí 1,1KPřed rokem
STERIS Technical Advisor Noel Gibbons and Product & Package Testing Manager Nate Wilhelm discuss how to perform accelerated aging and real time aging studies, along with their requirements and standards. This overview also outlines the importance of the sterile barrier system and how to meet standards and requirements for the life of the product. Accelerated Aging & Real Time Aging Studies Over...
The Importance Of Bioburden Testing & Control | STERIS AST TechTalk42:40The Importance Of Bioburden Testing & Control | STERIS AST TechTalk
The Importance Of Bioburden Testing & Control | STERIS AST TechTalk
zhlédnutí 2,2KPřed 2 lety
STERIS Principal Scientist Jason Rogers discusses the importance of bioburden testing to control bioburden in medical devices, pharmaceuticals, and raw material packaging. Understand how bioburden is enumerated and characterized, common sources of bioburden, methods for reducing bioburden, and how bioburden control results in safer products. Bioburden Testing & Control Overview: - Bioburden Tes...
Distribution Simulation Packaging Testing | STERIS AST TechTalk26:58Distribution Simulation Packaging Testing | STERIS AST TechTalk
Distribution Simulation Packaging Testing | STERIS AST TechTalk
zhlédnutí 905Před 2 lety
Nate Wilhelm, Senior Project Engineer at STERIS, shares an overview of distribution testing services specifically for sterile packaging and medical devices. Distribution simulation packaging testing is a key validation requirement for sterile medical devices, protecting the product through transport from manufacturer to consumer. Distribution Testing for Sterile Packaging & Devices Overview: - ...
X-ray Sterilization Facility in Venlo, The Netherlands | STERIS AST3:19X-ray Sterilization Facility in Venlo, The Netherlands | STERIS AST
X-ray Sterilization Facility in Venlo, The Netherlands | STERIS AST
zhlédnutí 5KPřed 2 lety
X-ray Sterilization Facility in Venlo, The Netherlands | STERIS AST
Radiation Technology Center Overview | STERIS AST2:46Radiation Technology Center Overview | STERIS AST
Radiation Technology Center Overview | STERIS AST
zhlédnutí 2,1KPřed 2 lety
Radiation Technology Center Overview | STERIS AST
Fundamentals of Bioburden Testing | STERIS AST TechTalk48:30Fundamentals of Bioburden Testing | STERIS AST TechTalk
Fundamentals of Bioburden Testing | STERIS AST TechTalk
zhlédnutí 12KPřed 2 lety
Fundamentals of Bioburden Testing | STERIS AST TechTalk
Introduction to the Ethylene Oxide Master File Pilot Program | STERIS AST TechTalk19:44Introduction to the Ethylene Oxide Master File Pilot Program | STERIS AST TechTalk
Introduction to the Ethylene Oxide Master File Pilot Program | STERIS AST TechTalk
zhlédnutí 522Před 2 lety
Introduction to the Ethylene Oxide Master File Pilot Program | STERIS AST TechTalk
Activation Testing in X-ray Irradiation Processing | STERIS AST TechTalk22:04Activation Testing in X-ray Irradiation Processing | STERIS AST TechTalk
Activation Testing in X-ray Irradiation Processing | STERIS AST TechTalk
zhlédnutí 730Před 2 lety
Activation Testing in X-ray Irradiation Processing | STERIS AST TechTalk
Radiation Technology Transfer for Sterilization Processing | STERIS AST TechTalk35:57Radiation Technology Transfer for Sterilization Processing | STERIS AST TechTalk
Radiation Technology Transfer for Sterilization Processing | STERIS AST TechTalk
zhlédnutí 1,8KPřed 2 lety
Radiation Technology Transfer for Sterilization Processing | STERIS AST TechTalk
Verification Dose: Complying with ISO 11137 | STERIS AST TechTalk30:04Verification Dose: Complying with ISO 11137 | STERIS AST TechTalk
Verification Dose: Complying with ISO 11137 | STERIS AST TechTalk
zhlédnutí 3,8KPřed 2 lety
Verification Dose: Complying with ISO 11137 | STERIS AST TechTalk
Effective Performance of Real-Time & Accelerated Aging Studies | STERIS AST TechTalk35:18Effective Performance of Real-Time & Accelerated Aging Studies | STERIS AST TechTalk
Effective Performance of Real-Time & Accelerated Aging Studies | STERIS AST TechTalk
zhlédnutí 1KPřed 2 lety
Effective Performance of Real-Time & Accelerated Aging Studies | STERIS AST TechTalk
Ethylene Oxide Residuals - Navigating ISO 10993-7 | STERIS AST TechTalk20:54Ethylene Oxide Residuals - Navigating ISO 10993-7 | STERIS AST TechTalk
Ethylene Oxide Residuals - Navigating ISO 10993-7 | STERIS AST TechTalk
zhlédnutí 2,2KPřed 2 lety
Ethylene Oxide Residuals - Navigating ISO 10993-7 | STERIS AST TechTalk
Using Uncertainty in Radiation Processing to Establish Process Target Dose | STERIS AST TechTalk16:59Using Uncertainty in Radiation Processing to Establish Process Target Dose | STERIS AST TechTalk
Using Uncertainty in Radiation Processing to Establish Process Target Dose | STERIS AST TechTalk
zhlédnutí 534Před 2 lety
Using Uncertainty in Radiation Processing to Establish Process Target Dose | STERIS AST TechTalk
Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk41:56Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk
Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk
zhlédnutí 1,5KPřed 3 lety
Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk
Parametric Release for Ethylene Oxide Sterilization | STERIS AST TechTalk22:31Parametric Release for Ethylene Oxide Sterilization | STERIS AST TechTalk
Parametric Release for Ethylene Oxide Sterilization | STERIS AST TechTalk
zhlédnutí 1,2KPřed 3 lety
Parametric Release for Ethylene Oxide Sterilization | STERIS AST TechTalk
Design Requirements for Luer Connectors | STERIS AST TechTalk25:58Design Requirements for Luer Connectors | STERIS AST TechTalk
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zhlédnutí 1,5KPřed 3 lety
Design Requirements for Luer Connectors | STERIS AST TechTalk
Establishing Specification Limits for Ethylene Oxide Sterilization | STERIS AST TechTalk39:30Establishing Specification Limits for Ethylene Oxide Sterilization | STERIS AST TechTalk
Establishing Specification Limits for Ethylene Oxide Sterilization | STERIS AST TechTalk
zhlédnutí 832Před 3 lety
Establishing Specification Limits for Ethylene Oxide Sterilization | STERIS AST TechTalk
Radiation Technology Center Service Offering | STERIS AST TechTalk31:23Radiation Technology Center Service Offering | STERIS AST TechTalk
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zhlédnutí 831Před 3 lety
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