REGULATORY
A Data-Driven Approach To Container Closure Integrity
Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
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.
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.
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.
Selecting Container Closure Components: Extractables And Leachables
Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.
The Container Closure Integrity Requirements In The Revised EU Annex 1
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
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.
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.
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.
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...
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.
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.
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...
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
Annex 1 FAQs: How Are We Responding To Foster Trust With Customers?
When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.
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.
EU Med Device Regulations: Ensuring Compliance For Integral Combination Products
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.
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.
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 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.
Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
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.
Understanding The Regulatory Landscape For Ophthalmic Drug Products
Learn how evolving ophthalmic regulations, contamination control strategies, and advanced packaging solutions can help support compliance, product quality, and patient safety.
Establishing A Container Closure System
As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.
Managing Risks In Injectable Drug Delivery
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
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.
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.
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.
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.