-
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
-
Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging
CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches. This presentation will review all the common CCIT methods found in USP 1207 to compare the testing options. The presentation then explores CCIT method validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.
- Deterministic vs. probabilistic methods (why choose one over the other)?
- How do the different methods work?
- How do you set up a validation for a CCIT method?
- What are some pitfalls to avoid during the validation?
published: 31 Jul 2023
-
CONTAINER CLOSURE INTEGRITY TESTING | PACKAGING AND LABELING | B.PHARM
CONTAINER CLOSURE INTEGRITY TESTING | TESTING OF CONTAINER AND CLOSURE | PACKAGING AND LABELING | B.PHARM
published: 31 May 2020
-
CDV Pharma 💊 Blister Blue Dye Leak Testing - Container Closure Integrity Testing CCIT
Leak Detector for
Pharmaceuticals with Methylene Blue Dye Test Method. CDV Pharma is a vacuum chamber for packaging leak testing focused on blister for pharmaceutical industry.
📌 Methylene Blue Dye Test Method ➡️ Is it going to work with my products? 📡
👇🏻👇🏻✉️✉️CONTACT US✉️✉️👇🏻👇🏻
➡️ https://www.dvaci.com/sterile-product-package-integrity-testing-cdv-pharma/?utm_source=youtube&utm_medium=social&utm_campaign=backlink&utm_content=cdvpharma
***FREE TEST***
➡️ Send us your samples, we will send you back free of charge a video of test results with your products and recommandations about testing parameters.
Lear about ASTM:
🎥 Which ASTM Standard to Choose for Your Package Leak Testing? 👉🏼https://youtu.be/U5OnRLKFyTs
-----
SIMILAR VIDEOS:
🎥 How does it work? 👉🏼 https://youtu.be/bEm_qHvbsZc ...
published: 01 Jul 2020
-
E-Scan 615 HVLD | Container Closure Integrity Testing | Parenterals
The E-Scan 615 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. This technolgy can be used with a wide range of liquid based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
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=escan615
#parenteral #hvld #ccit
published: 04 Aug 2022
-
Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components are compatible and fit for use. Additionally, USP 661.1, 661.2, & 382 will be official by end of year 2025. This webinar will review the changes these new general chapters bring.
By attending the webinar you will learn:
• Container closure requirements for parenteral products
• What changes are brought with USP 661.1, 661.2, & 382
• Nelson Lab’s capabilities to meet new chapter requirements.
Presented by Logan Luke and Shiri Hechter
published: 15 Sep 2023
-
Analytical Services –Container Closure Integrity Testing (CCIT)
In this Video Interview, Jessica Baseggio - SME Study Monitor in TEC Analytics – is speaking about the highest standards of CCIT to make newer, better, and safer medications.
Visit now our website: https://bit.ly/4bY114C
published: 11 Jun 2024
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I Mastered Container Closure Systems in 30 Days and Here's What I Learned
"In this video, I share my journey to mastering Container Closure Systems in just 30 days, offering you a complete guide on pharmaceutical packaging and the critical role these systems play in ensuring product quality, safety, and efficacy. In the pharmaceutical industry, a container closure system involves the combination of a container and closure that protects the drug product from contamination, moisture, and light while preserving its integrity throughout its shelf life.
With a focus on primary and secondary packaging, we explore the various types of container closure systems used across pharmaceuticals, such as glass bottles, plastic containers, vials, ampules, blister packs, and pre-filled syringes. Each system has its unique characteristics, especially regarding container closure ...
published: 24 Feb 2023
-
US Drug Delivery Combination Product Regulatory
This presentation will include a short summary of the types of Drug Delivery
Combination products codified by US FDA regulation, and the types of other
drug delivery products where the combination must be addressed.
It will detail the current technical expectations for development,
incorporating Design Verification approaches, including FDA Essential
Performance Requirements (EPRs), recently updated ISO 11608 series, and
FDA and IEC requirements for addressing Human factors; and GMP/System
requirements required under FDA 21 CFR Part 4 regulations.
Among other areas, the presentation will touch on requirements for clinical
requirements and unique challenges for generic products.
published: 14 Jul 2022
-
Analytical Services Across Your Combination Product’s Life Cycle | Kindeva Drug Delivery
Support your combination product’s compliance and quality with analytical services from Kindeva Drug Delivery, backed by over a century of experience.
We offer a wide range of analytical services for your drug, containment system, delivery system, device, or combination product, performed in accordance with cGMP standards. Services include analytical method development and validation, raw material testing, stability testing & storage, and extractables & leachables testing, with container closure integrity testing and elemental impurity testing coming in Q2 of 2024. As experts in combination product development and manufacturing, we also offer analytical services across pulmonary & nasal, injectable, and transdermal drug-delivery formats.
Discover our industry-leading capabilities:
A...
published: 02 Feb 2024
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
1:01:31
Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging
CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches. This pres...
CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches. This presentation will review all the common CCIT methods found in USP 1207 to compare the testing options. The presentation then explores CCIT method validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.
- Deterministic vs. probabilistic methods (why choose one over the other)?
- How do the different methods work?
- How do you set up a validation for a CCIT method?
- What are some pitfalls to avoid during the validation?
https://wn.com/Container_Closure_Integrity_Testing_(Ccit)_For_Pharmaceutical_Sterile_Barrier_Packaging
CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches. This presentation will review all the common CCIT methods found in USP 1207 to compare the testing options. The presentation then explores CCIT method validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.
- Deterministic vs. probabilistic methods (why choose one over the other)?
- How do the different methods work?
- How do you set up a validation for a CCIT method?
- What are some pitfalls to avoid during the validation?
- published: 31 Jul 2023
- views: 2711
18:53
CONTAINER CLOSURE INTEGRITY TESTING | PACKAGING AND LABELING | B.PHARM
CONTAINER CLOSURE INTEGRITY TESTING | TESTING OF CONTAINER AND CLOSURE | PACKAGING AND LABELING | B.PHARM
CONTAINER CLOSURE INTEGRITY TESTING | TESTING OF CONTAINER AND CLOSURE | PACKAGING AND LABELING | B.PHARM
https://wn.com/Container_Closure_Integrity_Testing_|_Packaging_And_Labeling_|_B.Pharm
CONTAINER CLOSURE INTEGRITY TESTING | TESTING OF CONTAINER AND CLOSURE | PACKAGING AND LABELING | B.PHARM
- published: 31 May 2020
- views: 2275
3:15
CDV Pharma 💊 Blister Blue Dye Leak Testing - Container Closure Integrity Testing CCIT
Leak Detector for
Pharmaceuticals with Methylene Blue Dye Test Method. CDV Pharma is a vacuum chamber for packaging leak testing focused on blister for pharmac...
Leak Detector for
Pharmaceuticals with Methylene Blue Dye Test Method. CDV Pharma is a vacuum chamber for packaging leak testing focused on blister for pharmaceutical industry.
📌 Methylene Blue Dye Test Method ➡️ Is it going to work with my products? 📡
👇🏻👇🏻✉️✉️CONTACT US✉️✉️👇🏻👇🏻
➡️ https://www.dvaci.com/sterile-product-package-integrity-testing-cdv-pharma/?utm_source=youtube&utm_medium=social&utm_campaign=backlink&utm_content=cdvpharma
***FREE TEST***
➡️ Send us your samples, we will send you back free of charge a video of test results with your products and recommandations about testing parameters.
Lear about ASTM:
🎥 Which ASTM Standard to Choose for Your Package Leak Testing? 👉🏼https://youtu.be/U5OnRLKFyTs
-----
SIMILAR VIDEOS:
🎥 How does it work? 👉🏼 https://youtu.be/bEm_qHvbsZc
#pharma #blister #leaktest
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
Model: CDV Pharma 💊
Brand: DVACI
Company: BOUSTENS SA DE CV
Subsidiary in USA 🇺🇸 DVACI LLC 🇺🇸
Subsidiary in Europe 🇪🇺 France: CONTROL-SENSEI SAS 🇫🇷
🇲🇽🇲🇽🇲🇽 Made in Mexico 🇲🇽🇲🇽🇲🇽
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
MORE VIDEOS ABOUT ASTM TEST METHOD:
🎥 ASTM D3078 | Vacuum Leak Test for FLEXIBLE PACKAGING 👉🏼 https://youtu.be/UOsuekFAdOs
🎥 ASTM D5094 / EN 14401 | Vacuum Leak Test for BOTTLES, CONTAINERS and CAPS 👉🏼 https://youtu.be/MilhBIs8GfI
🎥 ASTM D4991 | RIGID Container Leak Testing for Air Transport 👉🏼 https://youtu.be/dOnHn9lJ5yE
🎥 ASTM D6653: High Altitude Packaging System Testing with Vacuum Method 👉🏼
https://youtu.be/zEYlzhM8ocU
🎥 ASTM F2096 Bubble Test Explained for Packaging Integrity 👉🏼 https://youtu.be/CCmYyBf9FhI
👇🏻👇🏻👇🏻 Click to subscribe to our channel👇🏻👇🏻👇🏻
https://www.youtube.com/c/Dvaci/?sub_confirmation=1
Our Website 🖥
👉🏻 https://www.dvaci.com/?utm_source=youtube&utm_medium=social&utm_campaign=backlink&utm_content=cdvpharma 👈🏻
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
FOLLOW US:
👥 Linkedin: https://www.linkedin.com/company/2615524/
📷 Instagram: https://www.instagram.com/dvaci_cdv/
🚀 Youtube: https://www.youtube.com/c/Dvaci
🌐 DirectIndustry: https://www.directindustry.com/prod/dvaci-108237.html
👤 Facebook: https://www.facebook.com/dvaci
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
A simple, repeatable and
reliable method to ensure
seal integrity of your
packages and containers,
the CDV Pharma chamber
makes detection of even the
smallest leaks a possibility.
Compliant with 21 CFR part 11
CDV Pharma was designed to optimize the use
of blue methylene solution in leak testing.
CDV PHARMA vacuum chambers are built with a PLC touchscreen where vacuum
level and time can be set and controlled through a user-friendly, advanced interface. Access
to the program is password protected. Up to 40 users can be registered with personal
passwords for each.
Operating System: ORION
It is a powerful operating system that lets you install applications that adhere to the procedures stipulated in international norms and standards.
STANDARDS:
MGA 0486 FEUM
USP 1207.2 Package Integrity Leak Test Technologies – Probabilistic Leak Test Technologies: Bubble Emission and Tracer Liquid
ISO 8871-5
🍾 New video every week 🙀
👇🏻👇🏻👇🏻 Click to subscribe to our channel👇🏻👇🏻👇🏻
https://www.youtube.com/c/Dvaci/?sub_confirmation=1
Script and Video editing by:
Óscar Betancourt
https://picturelle.com/
CDV Pharma Blister Blue Dye Leak Testing - Container Closure Integrity Testing CCIT
https://youtu.be/gFdX2FBuCSA
https://youtu.be/gFdX2FBuCSA
https://wn.com/Cdv_Pharma_💊_Blister_Blue_Dye_Leak_Testing_Container_Closure_Integrity_Testing_Ccit
Leak Detector for
Pharmaceuticals with Methylene Blue Dye Test Method. CDV Pharma is a vacuum chamber for packaging leak testing focused on blister for pharmaceutical industry.
📌 Methylene Blue Dye Test Method ➡️ Is it going to work with my products? 📡
👇🏻👇🏻✉️✉️CONTACT US✉️✉️👇🏻👇🏻
➡️ https://www.dvaci.com/sterile-product-package-integrity-testing-cdv-pharma/?utm_source=youtube&utm_medium=social&utm_campaign=backlink&utm_content=cdvpharma
***FREE TEST***
➡️ Send us your samples, we will send you back free of charge a video of test results with your products and recommandations about testing parameters.
Lear about ASTM:
🎥 Which ASTM Standard to Choose for Your Package Leak Testing? 👉🏼https://youtu.be/U5OnRLKFyTs
-----
SIMILAR VIDEOS:
🎥 How does it work? 👉🏼 https://youtu.be/bEm_qHvbsZc
#pharma #blister #leaktest
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
Model: CDV Pharma 💊
Brand: DVACI
Company: BOUSTENS SA DE CV
Subsidiary in USA 🇺🇸 DVACI LLC 🇺🇸
Subsidiary in Europe 🇪🇺 France: CONTROL-SENSEI SAS 🇫🇷
🇲🇽🇲🇽🇲🇽 Made in Mexico 🇲🇽🇲🇽🇲🇽
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
MORE VIDEOS ABOUT ASTM TEST METHOD:
🎥 ASTM D3078 | Vacuum Leak Test for FLEXIBLE PACKAGING 👉🏼 https://youtu.be/UOsuekFAdOs
🎥 ASTM D5094 / EN 14401 | Vacuum Leak Test for BOTTLES, CONTAINERS and CAPS 👉🏼 https://youtu.be/MilhBIs8GfI
🎥 ASTM D4991 | RIGID Container Leak Testing for Air Transport 👉🏼 https://youtu.be/dOnHn9lJ5yE
🎥 ASTM D6653: High Altitude Packaging System Testing with Vacuum Method 👉🏼
https://youtu.be/zEYlzhM8ocU
🎥 ASTM F2096 Bubble Test Explained for Packaging Integrity 👉🏼 https://youtu.be/CCmYyBf9FhI
👇🏻👇🏻👇🏻 Click to subscribe to our channel👇🏻👇🏻👇🏻
https://www.youtube.com/c/Dvaci/?sub_confirmation=1
Our Website 🖥
👉🏻 https://www.dvaci.com/?utm_source=youtube&utm_medium=social&utm_campaign=backlink&utm_content=cdvpharma 👈🏻
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
FOLLOW US:
👥 Linkedin: https://www.linkedin.com/company/2615524/
📷 Instagram: https://www.instagram.com/dvaci_cdv/
🚀 Youtube: https://www.youtube.com/c/Dvaci
🌐 DirectIndustry: https://www.directindustry.com/prod/dvaci-108237.html
👤 Facebook: https://www.facebook.com/dvaci
〰️〰️〰️〰️〰️〰️〰️〰️〰️〰️
A simple, repeatable and
reliable method to ensure
seal integrity of your
packages and containers,
the CDV Pharma chamber
makes detection of even the
smallest leaks a possibility.
Compliant with 21 CFR part 11
CDV Pharma was designed to optimize the use
of blue methylene solution in leak testing.
CDV PHARMA vacuum chambers are built with a PLC touchscreen where vacuum
level and time can be set and controlled through a user-friendly, advanced interface. Access
to the program is password protected. Up to 40 users can be registered with personal
passwords for each.
Operating System: ORION
It is a powerful operating system that lets you install applications that adhere to the procedures stipulated in international norms and standards.
STANDARDS:
MGA 0486 FEUM
USP 1207.2 Package Integrity Leak Test Technologies – Probabilistic Leak Test Technologies: Bubble Emission and Tracer Liquid
ISO 8871-5
🍾 New video every week 🙀
👇🏻👇🏻👇🏻 Click to subscribe to our channel👇🏻👇🏻👇🏻
https://www.youtube.com/c/Dvaci/?sub_confirmation=1
Script and Video editing by:
Óscar Betancourt
https://picturelle.com/
CDV Pharma Blister Blue Dye Leak Testing - Container Closure Integrity Testing CCIT
https://youtu.be/gFdX2FBuCSA
https://youtu.be/gFdX2FBuCSA
- published: 01 Jul 2020
- views: 6133
1:23
E-Scan 615 HVLD | Container Closure Integrity Testing | Parenterals
The E-Scan 615 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and ...
The E-Scan 615 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. This technolgy can be used with a wide range of liquid based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
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=escan615
#parenteral #hvld #ccit
https://wn.com/E_Scan_615_Hvld_|_Container_Closure_Integrity_Testing_|_Parenterals
The E-Scan 615 is a revolutionary deterministic offline micro leak test instrument that utilizes a new class of HVLD technology to inspect vials, syringes, and other liquid filled parenteral products for container closure integrity. This technolgy can be used with a wide range of liquid based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.
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=escan615
#parenteral #hvld #ccit
- published: 04 Aug 2022
- views: 24575
48:01
Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components are compa...
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components are compatible and fit for use. Additionally, USP 661.1, 661.2, & 382 will be official by end of year 2025. This webinar will review the changes these new general chapters bring.
By attending the webinar you will learn:
• Container closure requirements for parenteral products
• What changes are brought with USP 661.1, 661.2, & 382
• Nelson Lab’s capabilities to meet new chapter requirements.
Presented by Logan Luke and Shiri Hechter
https://wn.com/Container_Closure_Requirements_Preparing_For_Usp_382,_661.1,_661.2
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components are compatible and fit for use. Additionally, USP 661.1, 661.2, & 382 will be official by end of year 2025. This webinar will review the changes these new general chapters bring.
By attending the webinar you will learn:
• Container closure requirements for parenteral products
• What changes are brought with USP 661.1, 661.2, & 382
• Nelson Lab’s capabilities to meet new chapter requirements.
Presented by Logan Luke and Shiri Hechter
- published: 15 Sep 2023
- views: 776
2:15
Analytical Services –Container Closure Integrity Testing (CCIT)
In this Video Interview, Jessica Baseggio - SME Study Monitor in TEC Analytics – is speaking about the highest standards of CCIT to make newer, better, and safe...
In this Video Interview, Jessica Baseggio - SME Study Monitor in TEC Analytics – is speaking about the highest standards of CCIT to make newer, better, and safer medications.
Visit now our website: https://bit.ly/4bY114C
https://wn.com/Analytical_Services_–Container_Closure_Integrity_Testing_(Ccit)
In this Video Interview, Jessica Baseggio - SME Study Monitor in TEC Analytics – is speaking about the highest standards of CCIT to make newer, better, and safer medications.
Visit now our website: https://bit.ly/4bY114C
- published: 11 Jun 2024
- views: 199
6:46
I Mastered Container Closure Systems in 30 Days and Here's What I Learned
"In this video, I share my journey to mastering Container Closure Systems in just 30 days, offering you a complete guide on pharmaceutical packaging and the cri...
"In this video, I share my journey to mastering Container Closure Systems in just 30 days, offering you a complete guide on pharmaceutical packaging and the critical role these systems play in ensuring product quality, safety, and efficacy. In the pharmaceutical industry, a container closure system involves the combination of a container and closure that protects the drug product from contamination, moisture, and light while preserving its integrity throughout its shelf life.
With a focus on primary and secondary packaging, we explore the various types of container closure systems used across pharmaceuticals, such as glass bottles, plastic containers, vials, ampules, blister packs, and pre-filled syringes. Each system has its unique characteristics, especially regarding container closure integrity, compatibility, and compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
What You'll Learn:
Overview of Container Closure Systems: What they are, their components, and why they matter in the pharmaceutical industry.
Types of Packaging Materials: From glass and plastic containers to rubber stoppers and aluminum seals, learn the features of each type and how they ensure product stability.
Quality Integrity: Understand the importance of container closure integrity testing for maintaining the safety of sterile and parenteral products.
Packaging Development: Gain insights into packaging design and testing processes, including stability testing, extractables and leachables, and compatibility testing.
Good Manufacturing Practices (GMP): Discover how GMPs apply to container closure systems, from aseptic processing to quality assurance and regulatory compliance.
Whether you’re a pharmaceutical professional or someone interested in pharmaceutical packaging and container closure systems, this video provides the knowledge and insights to understand and apply best practices in container closure integrity and quality control.
Key Topics Covered:
Container Closure System in the pharmaceutical industry
Pharmaceutical Packaging types and materials
Primary and Secondary Packaging concepts
Steps for maintaining Container Closure Integrity
Importance of Quality Control in GMP compliance
Aseptic Processing and Capping in sterile product handling
Packaging Development for drug stability and protection
Testing methods for Extractables and Leachables
Related Channels:
If you're interested in learning more about pharmaceutical packaging and container closure systems, check out these helpful YouTube channels:
@PharmaPackaging - Detailed insights into primary and secondary packaging, along with latest trends.
@GMPTraining - Offers educational content on Good Manufacturing Practices and quality control processes.
@ISPEOfficial - Covers regulatory compliance, GMP, and updates in pharmaceutical manufacturing.
@SterileProductQA - Specializes in aseptic processing and quality assurance for sterile and parenteral products.
@PharmaQbD - Focused on quality-by-design principles, packaging development, and regulatory standards.
Free Training & Reference Links:
ISPE Packaging Guidance: Learn more about container closure integrity testing and packaging material guidelines on ISPE's official site.
FDA Packaging Requirements: Access in-depth guidance on container closure systems from the FDA website.
Pharma Training Online: Enroll in free courses on pharmaceutical packaging and GMP compliance at Pharma Training.
If you found this video helpful, please like, subscribe, and share! For more updates on pharmaceutical manufacturing, quality assurance, and GMP compliance, follow our channel and explore our other videos on container closure systems and pharmaceutical packaging development.
Keywords: #ContainerClosureSystem #PharmaceuticalIndustry #PrimaryPackaging #SecondaryPackaging #DrugProduct #RegulatoryCompliance #GoodManufacturingPractices #GMP #QualityControl #PackagingMaterials #ContainerClosureIntegrity #ParenteralProducts #SterileProducts #GlassContainers #PlasticContainers #RubberStoppers #AluminumSeals #Crimping #Capping #AsepticProcessing #QualityAssurance #StabilityTesting #PackagingDevelopment #CompatibilityTesting #ExtractablesandLeachables #Biologics #Biosimilars #MedicalDevices #PharmaceuticalManufacturing
https://wn.com/I_Mastered_Container_Closure_Systems_In_30_Days_And_Here's_What_I_Learned
"In this video, I share my journey to mastering Container Closure Systems in just 30 days, offering you a complete guide on pharmaceutical packaging and the critical role these systems play in ensuring product quality, safety, and efficacy. In the pharmaceutical industry, a container closure system involves the combination of a container and closure that protects the drug product from contamination, moisture, and light while preserving its integrity throughout its shelf life.
With a focus on primary and secondary packaging, we explore the various types of container closure systems used across pharmaceuticals, such as glass bottles, plastic containers, vials, ampules, blister packs, and pre-filled syringes. Each system has its unique characteristics, especially regarding container closure integrity, compatibility, and compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
What You'll Learn:
Overview of Container Closure Systems: What they are, their components, and why they matter in the pharmaceutical industry.
Types of Packaging Materials: From glass and plastic containers to rubber stoppers and aluminum seals, learn the features of each type and how they ensure product stability.
Quality Integrity: Understand the importance of container closure integrity testing for maintaining the safety of sterile and parenteral products.
Packaging Development: Gain insights into packaging design and testing processes, including stability testing, extractables and leachables, and compatibility testing.
Good Manufacturing Practices (GMP): Discover how GMPs apply to container closure systems, from aseptic processing to quality assurance and regulatory compliance.
Whether you’re a pharmaceutical professional or someone interested in pharmaceutical packaging and container closure systems, this video provides the knowledge and insights to understand and apply best practices in container closure integrity and quality control.
Key Topics Covered:
Container Closure System in the pharmaceutical industry
Pharmaceutical Packaging types and materials
Primary and Secondary Packaging concepts
Steps for maintaining Container Closure Integrity
Importance of Quality Control in GMP compliance
Aseptic Processing and Capping in sterile product handling
Packaging Development for drug stability and protection
Testing methods for Extractables and Leachables
Related Channels:
If you're interested in learning more about pharmaceutical packaging and container closure systems, check out these helpful YouTube channels:
@PharmaPackaging - Detailed insights into primary and secondary packaging, along with latest trends.
@GMPTraining - Offers educational content on Good Manufacturing Practices and quality control processes.
@ISPEOfficial - Covers regulatory compliance, GMP, and updates in pharmaceutical manufacturing.
@SterileProductQA - Specializes in aseptic processing and quality assurance for sterile and parenteral products.
@PharmaQbD - Focused on quality-by-design principles, packaging development, and regulatory standards.
Free Training & Reference Links:
ISPE Packaging Guidance: Learn more about container closure integrity testing and packaging material guidelines on ISPE's official site.
FDA Packaging Requirements: Access in-depth guidance on container closure systems from the FDA website.
Pharma Training Online: Enroll in free courses on pharmaceutical packaging and GMP compliance at Pharma Training.
If you found this video helpful, please like, subscribe, and share! For more updates on pharmaceutical manufacturing, quality assurance, and GMP compliance, follow our channel and explore our other videos on container closure systems and pharmaceutical packaging development.
Keywords: #ContainerClosureSystem #PharmaceuticalIndustry #PrimaryPackaging #SecondaryPackaging #DrugProduct #RegulatoryCompliance #GoodManufacturingPractices #GMP #QualityControl #PackagingMaterials #ContainerClosureIntegrity #ParenteralProducts #SterileProducts #GlassContainers #PlasticContainers #RubberStoppers #AluminumSeals #Crimping #Capping #AsepticProcessing #QualityAssurance #StabilityTesting #PackagingDevelopment #CompatibilityTesting #ExtractablesandLeachables #Biologics #Biosimilars #MedicalDevices #PharmaceuticalManufacturing
- published: 24 Feb 2023
- views: 2650
23:49
US Drug Delivery Combination Product Regulatory
This presentation will include a short summary of the types of Drug Delivery
Combination products codified by US FDA regulation, and the types of other
drug del...
This presentation will include a short summary of the types of Drug Delivery
Combination products codified by US FDA regulation, and the types of other
drug delivery products where the combination must be addressed.
It will detail the current technical expectations for development,
incorporating Design Verification approaches, including FDA Essential
Performance Requirements (EPRs), recently updated ISO 11608 series, and
FDA and IEC requirements for addressing Human factors; and GMP/System
requirements required under FDA 21 CFR Part 4 regulations.
Among other areas, the presentation will touch on requirements for clinical
requirements and unique challenges for generic products.
https://wn.com/US_Drug_Delivery_Combination_Product_Regulatory
This presentation will include a short summary of the types of Drug Delivery
Combination products codified by US FDA regulation, and the types of other
drug delivery products where the combination must be addressed.
It will detail the current technical expectations for development,
incorporating Design Verification approaches, including FDA Essential
Performance Requirements (EPRs), recently updated ISO 11608 series, and
FDA and IEC requirements for addressing Human factors; and GMP/System
requirements required under FDA 21 CFR Part 4 regulations.
Among other areas, the presentation will touch on requirements for clinical
requirements and unique challenges for generic products.
- published: 14 Jul 2022
- views: 657
1:39
Analytical Services Across Your Combination Product’s Life Cycle | Kindeva Drug Delivery
Support your combination product’s compliance and quality with analytical services from Kindeva Drug Delivery, backed by over a century of experience.
We offe...
Support your combination product’s compliance and quality with analytical services from Kindeva Drug Delivery, backed by over a century of experience.
We offer a wide range of analytical services for your drug, containment system, delivery system, device, or combination product, performed in accordance with cGMP standards. Services include analytical method development and validation, raw material testing, stability testing & storage, and extractables & leachables testing, with container closure integrity testing and elemental impurity testing coming in Q2 of 2024. As experts in combination product development and manufacturing, we also offer analytical services across pulmonary & nasal, injectable, and transdermal drug-delivery formats.
Discover our industry-leading capabilities:
Analytical Services: https://www.kindevadd.com/analytical-services/
Full-Service Contract Development & Manufacturing (CDMO): https://www.kindevadd.com/cdmo-capabilities/
Pulmonary & Nasal (metered-dose inhalers, dry powder inhalers, soft mist inhalers, and nebulizers): https://www.kindevadd.com/idd/
Injectables (autoinjectors, vials, cartridges, and syringes): https://www.kindevadd.com/parenteral-drug-delivery/
Transdermal Patches: https://www.kindevadd.com/tdd/
Biologic Drug Development: https://www.kindevadd.com/biologics/
Ten State-of-the-Art Facilities: https://www.kindevadd.com/facilities/
Sustainability: https://www.kindevadd.com/sustainability/
Follow us on social media:
LinkedIn: https://www.linkedin.com/company/kindeva-drug-delivery/
Facebook: https://www.facebook.com/KindevaDrugD/
X: https://twitter.com/KindevaDrugD
https://wn.com/Analytical_Services_Across_Your_Combination_Product’S_Life_Cycle_|_Kindeva_Drug_Delivery
Support your combination product’s compliance and quality with analytical services from Kindeva Drug Delivery, backed by over a century of experience.
We offer a wide range of analytical services for your drug, containment system, delivery system, device, or combination product, performed in accordance with cGMP standards. Services include analytical method development and validation, raw material testing, stability testing & storage, and extractables & leachables testing, with container closure integrity testing and elemental impurity testing coming in Q2 of 2024. As experts in combination product development and manufacturing, we also offer analytical services across pulmonary & nasal, injectable, and transdermal drug-delivery formats.
Discover our industry-leading capabilities:
Analytical Services: https://www.kindevadd.com/analytical-services/
Full-Service Contract Development & Manufacturing (CDMO): https://www.kindevadd.com/cdmo-capabilities/
Pulmonary & Nasal (metered-dose inhalers, dry powder inhalers, soft mist inhalers, and nebulizers): https://www.kindevadd.com/idd/
Injectables (autoinjectors, vials, cartridges, and syringes): https://www.kindevadd.com/parenteral-drug-delivery/
Transdermal Patches: https://www.kindevadd.com/tdd/
Biologic Drug Development: https://www.kindevadd.com/biologics/
Ten State-of-the-Art Facilities: https://www.kindevadd.com/facilities/
Sustainability: https://www.kindevadd.com/sustainability/
Follow us on social media:
LinkedIn: https://www.linkedin.com/company/kindeva-drug-delivery/
Facebook: https://www.facebook.com/KindevaDrugD/
X: https://twitter.com/KindevaDrugD
- published: 02 Feb 2024
- views: 216