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West Analytical Services: Container Closure Integrity
With a lab built around USP 1207 guidance, West’s Container Closure Integrity experts provide packaging characterization data as well as validated methods and data for a regulatory filing or submission.
published: 02 May 2018
-
Container Closure Integrity Testing | CCIT Parenterals | Vacuum & Pressure Decay | Sepha Multi-Q
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, rigid or flexible packaging. Get more information: https://sepha.com/products/leak-testing/multi-q/
The Sepha Multi-Q is a standalone, multi-functional, non-destructive leak test system that can be used in combination with interchangeable test methods to fit the full range of container types available on the market today.
The multi-functional system offers an all-in-one solution to test the integrity of all types of containers including sachets, pouches, bags, bottles, vials, ampoules, trays, devices and modified atmosphere packaging (MAP). The lab-scale unit has a small footprint and offers the flexibility to test different contain...
published: 25 Jun 2021
-
Packaging Crash Course - Closures 101
Common container and closure dimension specifications were established to ensure a perfect fit and successful packaging. Learn about each dimension and how they interact here.
published: 12 Sep 2014
-
VeriPac 465 Container Closure Integrity Leak Detection System
The VeriPac 465 is a deterministic micro leak test system for container
closure integrity testing for parenteral products and rigid containers that require precise measurement and detection of the smallest leaks. Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/vacuum-decay?utm_source=youtube&utm_medium=video&utm_campaign=veripac465
#veripac #packageintegritytesting #ccit
published: 12 Nov 2021
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Container-Closure Integrity Testing for Drug Delivery Devices
Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the design verification study, to manufacturing, through commercial stability, and in many cases in lieu of sterility testing. So, what exactly is meant by the term container-closure integrity, and how can an appropriate leak testing technology be selected for a drug delivery device such as a pre-filled syringe, a cartridge, an auto-injector, or a pen injector? This presentation will compare various container-closure integrity testing technologies, will explore the applications of these technologies at different phases of the product-package life cycle, and will discuss method development and validation strategies to ensure the steri...
published: 28 Nov 2018
-
PDA Europe - Container Closure Integrity Testing
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycle. The course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this course, participants gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-wor...
published: 26 Feb 2020
-
Laser based Headspace Analysis as a Container Closure Integrity Testing Tool
Laser-based Headspace Analysis as a Container Closure Integrity Testing Tool.
About the Webinar
Container Closure Integrity Testing (CCIT) has become a relevant topic in new regulatory documents like the USP1207 and the Annex 1 of the European Good Manufacturing Practice (GMP) guidelines. In view of this, the webinar shows the technologies available and their use. A detailed view is given to the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology. The correct use during the container closure development and parenteral packaging process allows the TDLAS technology to be an accurate, reliable and fast CCIT tool. Relevant parameters are highlighted to define the process parameters for designing a highly sensitive leak-test method.
About Rona...
published: 11 Aug 2021
-
Automated Container Closure Integrity Testing | MicroCurrent HVLD Technology | Parenterals
PTI’s E-Scan RTX is a fully automated CCI inspection system for pre-filled syringes. Utilizing a revolutionary deterministic technology, MicroCurrent HVLD, it is the optimal solution for all parenteral and biologic products. The E-Scan RTX features a dynamic robotic design tailored to fit your production requirements. Visit our website to know more about our products and services.
Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/hvld?utm_source=youtube&utm_medium=video&utm_campaign=escan
#automatedcci #packageintegritytesting #ccit #automatedcontainerclosureintegritytesting
published: 20 Feb 2023
-
Container Closure Integrity Testing - Sepha Multi-Q (LINK TO NEW VIDEO)
NEWER VERSION AVAILABLE BELOW:
https://youtu.be/nW71UOBY-ZI
https://sepha.com/products/leak-testing/multi-q/
Interesting links:
* Full range of Leak Test solutions: https://sepha.com/products/leak-testing
* Full range of Deblistering solutions: https://sepha.com/products/deblistering
* Full range of Packaging solutions: https://sepha.com/products/packaging-solutions
Follow us:
* Website: https://sepha.com
* LinkedIN: https://www.linkedin.com/company/sepha-ltd
* Twitter: https://www.twitter.com/sephaltd
published: 03 Apr 2019
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Why your container closure choice matters in sterile fill finish
When there are so many important aspects to developing and manufacturing a sterile drug product, container closure materials are often overlooked. However, the vial, syringe, stopper, or plunger you choose can have important implications for your drug product.
In this webinar, we describe what matters when deciding on your container closure materials. We also discuss the effects your primary container closure can have on your drug product stability, efficacy, and manufacturing process. We will describe how to avoid supply shortages, where substitutions can and can’t be made, and a new container closure product to protect your product!
00:00 - Intro
01:14 - Deciding on a container closure system
03:04 - What your fill finish CMO cares about
04:18 - Compatibility issues stories
06:33 - Eff...
published: 18 Jan 2023
1:24
West Analytical Services: Container Closure Integrity
With a lab built around USP 1207 guidance, West’s Container Closure Integrity experts provide packaging characterization data as well as validated methods and d...
With a lab built around USP 1207 guidance, West’s Container Closure Integrity experts provide packaging characterization data as well as validated methods and data for a regulatory filing or submission.
https://wn.com/West_Analytical_Services_Container_Closure_Integrity
With a lab built around USP 1207 guidance, West’s Container Closure Integrity experts provide packaging characterization data as well as validated methods and data for a regulatory filing or submission.
- published: 02 May 2018
- views: 1325
2:00
Container Closure Integrity Testing | CCIT Parenterals | Vacuum & Pressure Decay | Sepha Multi-Q
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, ri...
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, rigid or flexible packaging. Get more information: https://sepha.com/products/leak-testing/multi-q/
The Sepha Multi-Q is a standalone, multi-functional, non-destructive leak test system that can be used in combination with interchangeable test methods to fit the full range of container types available on the market today.
The multi-functional system offers an all-in-one solution to test the integrity of all types of containers including sachets, pouches, bags, bottles, vials, ampoules, trays, devices and modified atmosphere packaging (MAP). The lab-scale unit has a small footprint and offers the flexibility to test different container types by use of interchangeable tooling and test methods including vacuum and pressure decay. The tooling can be easily changed and the relevant recipes for the selected attachment will be available to start testing immediately.
The non-destructive and deterministic test methods provide quick, reliable and repeatable results enabling customers to improve the accuracy of their leak detection procedures and reduce cost as the method prevents the packaging from being damaged. The testing methods compatible with the Sepha Multi-Q include Flexible Membrane, Vacuum Decay, Pressure Decay, Ramp to Event, Ramp to Proof Pressure and Occlusion.
Interesting links:
* Full range of Leak Test solutions: https://sepha.com/products/leak-testing
* Full range of Deblistering solutions: https://sepha.com/products/deblistering
* Full range of Packaging solutions: https://sepha.com/products/packaging-solutions
* Contract Packaging Services: https://sepha.com/services/contract-packaging
Follow us:
* Website: https://sepha.com
* LinkedIn: https://www.linkedin.com/company/sepha-ltd
* Twitter: https://www.twitter.com/sephaltd
#ccit #astm #leakdetection #qualitycontrol #vials # ampoule #sepha #pharmaceuticalmanufacturing
https://wn.com/Container_Closure_Integrity_Testing_|_Ccit_Parenterals_|_Vacuum_Pressure_Decay_|_Sepha_Multi_Q
The Sepha Multi-Q is a non-destructive, deterministic and multi-functional Container Closure Integrity Testing system designed to detect leaks in non-porous, rigid or flexible packaging. Get more information: https://sepha.com/products/leak-testing/multi-q/
The Sepha Multi-Q is a standalone, multi-functional, non-destructive leak test system that can be used in combination with interchangeable test methods to fit the full range of container types available on the market today.
The multi-functional system offers an all-in-one solution to test the integrity of all types of containers including sachets, pouches, bags, bottles, vials, ampoules, trays, devices and modified atmosphere packaging (MAP). The lab-scale unit has a small footprint and offers the flexibility to test different container types by use of interchangeable tooling and test methods including vacuum and pressure decay. The tooling can be easily changed and the relevant recipes for the selected attachment will be available to start testing immediately.
The non-destructive and deterministic test methods provide quick, reliable and repeatable results enabling customers to improve the accuracy of their leak detection procedures and reduce cost as the method prevents the packaging from being damaged. The testing methods compatible with the Sepha Multi-Q include Flexible Membrane, Vacuum Decay, Pressure Decay, Ramp to Event, Ramp to Proof Pressure and Occlusion.
Interesting links:
* Full range of Leak Test solutions: https://sepha.com/products/leak-testing
* Full range of Deblistering solutions: https://sepha.com/products/deblistering
* Full range of Packaging solutions: https://sepha.com/products/packaging-solutions
* Contract Packaging Services: https://sepha.com/services/contract-packaging
Follow us:
* Website: https://sepha.com
* LinkedIn: https://www.linkedin.com/company/sepha-ltd
* Twitter: https://www.twitter.com/sephaltd
#ccit #astm #leakdetection #qualitycontrol #vials # ampoule #sepha #pharmaceuticalmanufacturing
- published: 25 Jun 2021
- views: 2770
1:51
Packaging Crash Course - Closures 101
Common container and closure dimension specifications were established to ensure a perfect fit and successful packaging. Learn about each dimension and how they...
Common container and closure dimension specifications were established to ensure a perfect fit and successful packaging. Learn about each dimension and how they interact here.
https://wn.com/Packaging_Crash_Course_Closures_101
Common container and closure dimension specifications were established to ensure a perfect fit and successful packaging. Learn about each dimension and how they interact here.
- published: 12 Sep 2014
- views: 94884
1:39
VeriPac 465 Container Closure Integrity Leak Detection System
The VeriPac 465 is a deterministic micro leak test system for container
closure integrity testing for parenteral products and rigid containers that require prec...
The VeriPac 465 is a deterministic micro leak test system for container
closure integrity testing for parenteral products and rigid containers that require precise measurement and detection of the smallest leaks. Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/vacuum-decay?utm_source=youtube&utm_medium=video&utm_campaign=veripac465
#veripac #packageintegritytesting #ccit
https://wn.com/Veripac_465_Container_Closure_Integrity_Leak_Detection_System
The VeriPac 465 is a deterministic micro leak test system for container
closure integrity testing for parenteral products and rigid containers that require precise measurement and detection of the smallest leaks. Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/vacuum-decay?utm_source=youtube&utm_medium=video&utm_campaign=veripac465
#veripac #packageintegritytesting #ccit
- published: 12 Nov 2021
- views: 2044
33:57
Container-Closure Integrity Testing for Drug Delivery Devices
Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the...
Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the design verification study, to manufacturing, through commercial stability, and in many cases in lieu of sterility testing. So, what exactly is meant by the term container-closure integrity, and how can an appropriate leak testing technology be selected for a drug delivery device such as a pre-filled syringe, a cartridge, an auto-injector, or a pen injector? This presentation will compare various container-closure integrity testing technologies, will explore the applications of these technologies at different phases of the product-package life cycle, and will discuss method development and validation strategies to ensure the sterility and quality of the drug product while packaged in the drug delivery device through to expiry.
https://wn.com/Container_Closure_Integrity_Testing_For_Drug_Delivery_Devices
Container-closure integrity is evaluated during all phases of the product-package life cycle for a drug delivery device from package development, as part of the design verification study, to manufacturing, through commercial stability, and in many cases in lieu of sterility testing. So, what exactly is meant by the term container-closure integrity, and how can an appropriate leak testing technology be selected for a drug delivery device such as a pre-filled syringe, a cartridge, an auto-injector, or a pen injector? This presentation will compare various container-closure integrity testing technologies, will explore the applications of these technologies at different phases of the product-package life cycle, and will discuss method development and validation strategies to ensure the sterility and quality of the drug product while packaged in the drug delivery device through to expiry.
- published: 28 Nov 2018
- views: 9643
2:18
PDA Europe - Container Closure Integrity Testing
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing meth...
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycle. The course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this course, participants gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies
https://wn.com/Pda_Europe_Container_Closure_Integrity_Testing
This course focuses on theoretical and practical fundamentals of various CCI testing technologies and provides a systematic approach to apply these testing methods for CCI verification throughout drug product lifecycle. The course will enable the participants to implement CCI testing strategies to ensure adequate drug product protection and be compliant with relevant regulatory and compendia requirements. In this course, participants gain critical problem solving skills through:
• interactive discussions with a panel of cross-functional technical experts consisting of CCI testing laboratory experts, testing instrument suppliers/manufacturers, and pharmaceutical packaging development engineers
• hands-on testing training on the newest innovations and state-of-the-art instruments
• real-world case studies
- published: 26 Feb 2020
- views: 959
1:31:02
Laser based Headspace Analysis as a Container Closure Integrity Testing Tool
Laser-based Headspace Analysis as a Container Closure Integrity Testing Tool.
About the Webinar
Container Closure Integrity Testing (CCIT) has become a relevan...
Laser-based Headspace Analysis as a Container Closure Integrity Testing Tool.
About the Webinar
Container Closure Integrity Testing (CCIT) has become a relevant topic in new regulatory documents like the USP1207 and the Annex 1 of the European Good Manufacturing Practice (GMP) guidelines. In view of this, the webinar shows the technologies available and their use. A detailed view is given to the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology. The correct use during the container closure development and parenteral packaging process allows the TDLAS technology to be an accurate, reliable and fast CCIT tool. Relevant parameters are highlighted to define the process parameters for designing a highly sensitive leak-test method.
About Ronald Koch
Roland studied electrical engineering at the technical university of BASEL Switzerland. He has a wide experience in the field of industrial applications for testing and quality inspection for more than 20 years. He developed a variety of test systems, applications and machines for the pharma, food, metal can and automotive industry. TDLAS for the quality inspection of headspace inspection for pharmaceutical packaging, NIR Spectroscopy to characterize lyophilized drugs for their moisture and cake defects, high sensitive Microfocus x-Ray Technology to inspect pharmaceutical containers for smallest foreign particles , high speed x-Ray inspection up to a frame rate of 200 frames per second, Mass Spectrometry for sensitive leak testing in the industrial environment, NDIR Gas Sensing for leak testing, Pressure Change Methods for leak testing, Force Sensors for leak testing. He built up a validation team to implement the requirements for the qualification of pharmaceutical equipment according to the GAMP requirements. Since 2018 he is Senior Application and Sales Manager at GASPOROX, a Lund (Sweden) located company which is highly specialized in laser based non-destructive gas measurements of parenteral packages.
https://wn.com/Laser_Based_Headspace_Analysis_As_A_Container_Closure_Integrity_Testing_Tool
Laser-based Headspace Analysis as a Container Closure Integrity Testing Tool.
About the Webinar
Container Closure Integrity Testing (CCIT) has become a relevant topic in new regulatory documents like the USP1207 and the Annex 1 of the European Good Manufacturing Practice (GMP) guidelines. In view of this, the webinar shows the technologies available and their use. A detailed view is given to the technology, use and application of the Tuneable Diode Laser Absorption Spectroscopy (TDLAS) technology. The correct use during the container closure development and parenteral packaging process allows the TDLAS technology to be an accurate, reliable and fast CCIT tool. Relevant parameters are highlighted to define the process parameters for designing a highly sensitive leak-test method.
About Ronald Koch
Roland studied electrical engineering at the technical university of BASEL Switzerland. He has a wide experience in the field of industrial applications for testing and quality inspection for more than 20 years. He developed a variety of test systems, applications and machines for the pharma, food, metal can and automotive industry. TDLAS for the quality inspection of headspace inspection for pharmaceutical packaging, NIR Spectroscopy to characterize lyophilized drugs for their moisture and cake defects, high sensitive Microfocus x-Ray Technology to inspect pharmaceutical containers for smallest foreign particles , high speed x-Ray inspection up to a frame rate of 200 frames per second, Mass Spectrometry for sensitive leak testing in the industrial environment, NDIR Gas Sensing for leak testing, Pressure Change Methods for leak testing, Force Sensors for leak testing. He built up a validation team to implement the requirements for the qualification of pharmaceutical equipment according to the GAMP requirements. Since 2018 he is Senior Application and Sales Manager at GASPOROX, a Lund (Sweden) located company which is highly specialized in laser based non-destructive gas measurements of parenteral packages.
- published: 11 Aug 2021
- views: 3523
1:50
Automated Container Closure Integrity Testing | MicroCurrent HVLD Technology | Parenterals
PTI’s E-Scan RTX is a fully automated CCI inspection system for pre-filled syringes. Utilizing a revolutionary deterministic technology, MicroCurrent HVLD, it ...
PTI’s E-Scan RTX is a fully automated CCI inspection system for pre-filled syringes. Utilizing a revolutionary deterministic technology, MicroCurrent HVLD, it is the optimal solution for all parenteral and biologic products. The E-Scan RTX features a dynamic robotic design tailored to fit your production requirements. Visit our website to know more about our products and services.
Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/hvld?utm_source=youtube&utm_medium=video&utm_campaign=escan
#automatedcci #packageintegritytesting #ccit #automatedcontainerclosureintegritytesting
https://wn.com/Automated_Container_Closure_Integrity_Testing_|_Microcurrent_Hvld_Technology_|_Parenterals
PTI’s E-Scan RTX is a fully automated CCI inspection system for pre-filled syringes. Utilizing a revolutionary deterministic technology, MicroCurrent HVLD, it is the optimal solution for all parenteral and biologic products. The E-Scan RTX features a dynamic robotic design tailored to fit your production requirements. Visit our website to know more about our products and services.
Visit our website to know more about our products and services.
https://www.pti-ccit.com/technologies/hvld?utm_source=youtube&utm_medium=video&utm_campaign=escan
#automatedcci #packageintegritytesting #ccit #automatedcontainerclosureintegritytesting
- published: 20 Feb 2023
- views: 550
0:31
Container Closure Integrity Testing - Sepha Multi-Q (LINK TO NEW VIDEO)
NEWER VERSION AVAILABLE BELOW:
https://youtu.be/nW71UOBY-ZI
https://sepha.com/products/leak-testing/multi-q/
Interesting links:
* Full range of Leak Test solu...
NEWER VERSION AVAILABLE BELOW:
https://youtu.be/nW71UOBY-ZI
https://sepha.com/products/leak-testing/multi-q/
Interesting links:
* Full range of Leak Test solutions: https://sepha.com/products/leak-testing
* Full range of Deblistering solutions: https://sepha.com/products/deblistering
* Full range of Packaging solutions: https://sepha.com/products/packaging-solutions
Follow us:
* Website: https://sepha.com
* LinkedIN: https://www.linkedin.com/company/sepha-ltd
* Twitter: https://www.twitter.com/sephaltd
https://wn.com/Container_Closure_Integrity_Testing_Sepha_Multi_Q_(Link_To_New_Video)
NEWER VERSION AVAILABLE BELOW:
https://youtu.be/nW71UOBY-ZI
https://sepha.com/products/leak-testing/multi-q/
Interesting links:
* Full range of Leak Test solutions: https://sepha.com/products/leak-testing
* Full range of Deblistering solutions: https://sepha.com/products/deblistering
* Full range of Packaging solutions: https://sepha.com/products/packaging-solutions
Follow us:
* Website: https://sepha.com
* LinkedIN: https://www.linkedin.com/company/sepha-ltd
* Twitter: https://www.twitter.com/sephaltd
- published: 03 Apr 2019
- views: 6166
37:53
Why your container closure choice matters in sterile fill finish
When there are so many important aspects to developing and manufacturing a sterile drug product, container closure materials are often overlooked. However, the ...
When there are so many important aspects to developing and manufacturing a sterile drug product, container closure materials are often overlooked. However, the vial, syringe, stopper, or plunger you choose can have important implications for your drug product.
In this webinar, we describe what matters when deciding on your container closure materials. We also discuss the effects your primary container closure can have on your drug product stability, efficacy, and manufacturing process. We will describe how to avoid supply shortages, where substitutions can and can’t be made, and a new container closure product to protect your product!
00:00 - Intro
01:14 - Deciding on a container closure system
03:04 - What your fill finish CMO cares about
04:18 - Compatibility issues stories
06:33 - Effects to your drug product & filling requirements
14:09 - What you need to consider
15:30 - Drug product compatibility
17:15 - Filling line compatibility
20:02 - Patient usability
20:35 - Patient safety
21:52 - Avoiding delays
22:56 - PremiumCoat platform
25:52 - Trends we are seeing
28:14 - Common pitfalls
29:17 - Avoiding supply chain issues
31:15 - Transition Q&A
32:27 - Q&A
36:50 - Conclusion
https://wn.com/Why_Your_Container_Closure_Choice_Matters_In_Sterile_Fill_Finish
When there are so many important aspects to developing and manufacturing a sterile drug product, container closure materials are often overlooked. However, the vial, syringe, stopper, or plunger you choose can have important implications for your drug product.
In this webinar, we describe what matters when deciding on your container closure materials. We also discuss the effects your primary container closure can have on your drug product stability, efficacy, and manufacturing process. We will describe how to avoid supply shortages, where substitutions can and can’t be made, and a new container closure product to protect your product!
00:00 - Intro
01:14 - Deciding on a container closure system
03:04 - What your fill finish CMO cares about
04:18 - Compatibility issues stories
06:33 - Effects to your drug product & filling requirements
14:09 - What you need to consider
15:30 - Drug product compatibility
17:15 - Filling line compatibility
20:02 - Patient usability
20:35 - Patient safety
21:52 - Avoiding delays
22:56 - PremiumCoat platform
25:52 - Trends we are seeing
28:14 - Common pitfalls
29:17 - Avoiding supply chain issues
31:15 - Transition Q&A
32:27 - Q&A
36:50 - Conclusion
- published: 18 Jan 2023
- views: 576