REGULATORY
Package Integrity Testing Of Dry-Fill Flexible Packaging With VeriPac FLEX
The VeriPac FLEX Systems are available in several configurations to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics.
Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers?
For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.
How To Evaluate The Integrity Of Intravenous (IV) Bags
Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.
Annex 1 FAQs: Responding To The 2022 Revision
Viewing the Annex 1 revision as a natural extension of current habits, rather than a burden, allowed for a seamless transition. Since contamination control was already standard, the update simply validated existing excellence.
VeriPac 465 Micro Leak Test System For Parenteral Products And Rigid Containers
The VeriPac 465 is a deterministic micro leak test system for container closure integrity testing combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based...
Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability
Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.
The Impact Of Water Activity Testing On Tablets And Capsules
Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.
Start Packaging Development Early
To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.
Human Factors Testing: Engaging End-Users In Med Device Development
Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.
Seal-Sensor Technology For In-Line Pouch Seal Inspection
PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructiv...
Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1?
EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.
Navigating GxP Compliance Challenges
Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
How Crucial Is Culture Media Selection In Environmental Monitoring?
Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.
Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here?
There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field...
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
Nitrosamine Impurities Deadline: Are Your Products Compliant?
Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.
Attracting The Right Capital — Forming Partnerships For Long-Term Success
Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.
Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1?
Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.
Combination Products: Navigating Regulatory Strategy, Design Verification
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
Advanced CCIT Strategies For Combination Products
Gain insight into how deterministic CCIT methods support sterility assurance, product stability, and patient safety for prefilled syringes, auto-injectors, and other combination products.
Micro Leak Detection Of Syringes, Vials And Liquid Filled Packaging With The VeriPac 455
VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging. The VeriPac 455 inspection technology that can be incorporated into pr...
Planning For Scale-Up
From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.
An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data
Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
How RTU Solutions Can Meet GMP Annex 1 Requirements
EU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.
The Sensitivity Trap: Building Confidence In CCIT Performance
Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.
Your Contract Manufacturer Partner
Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.
Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations?
Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.
Artificial Intelligence's Potential In Pharma Manufacturing
Explore how pharma companies can leverage Stevanato Group’s AI technologies while navigating FDA’s evolving, risk-based regulatory approach to disruptive innovations in this webinar.
Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.