INSIGHTS ON PHARMACEUTICAL INSPECTION
-
Ensuring Integrity: A Comprehensive Approach To CCI
Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.
-
Effective Strategies To Minimize Product Loss During Fill Finish
Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.
-
Part I: Defining The Dye Ingress Operating Window
Dye ingress testing depends on pressure dynamics that shift with viscosity. Discover how these constraints narrow its operating window and call into question its reliability for high‑risk applications.
-
Building A Defensible Visual Inspection Program With Purpose-Built Software
Ditch the spreadsheets and de-risk your visual inspection workflow. Learn how purpose-built software automates inspector scheduling and builds a fully defensible, audit-ready cGMP compliance program.
-
Part II: Defining The Dye Ingress Operating Window2/12/2026
Learn about the viscosity-driven limits of dye ingress testing, translating qualitative constraints into a quantitative feasibility boundary shaped by defect size, pressure behavior, and plunger mechanics.
-
Helium Leak Detection On Glass Cartridge Containers1/5/2026
Helium leak detection offers unmatched sensitivity for verifying glass cartridge seal integrity. Learn how this advanced method outperforms traditional tests and provides confidence in packaging.
-
Expanding Subcutaneous Design Brick By Brick8/14/2026
Biologics are growing more complex. But what if the syringe itself could unlock new possibilities? Discover the technology “bricks” quietly reshaping subcutaneous drug delivery.
-
Lessons From FDA 483s And Warning Letters: Cleanroom Compliance12/8/2025
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
-
ADC Drug Products: Solutions To Manage Risks And Enhance Stability7/2/2026
Discover how an integrated ADC strategy addresses containment, analytics, fill-finish, and inspection challenges to improve product protection, process reliability, and delivery performance.
PHARMACEUTICAL INSPECTION SOLUTIONS
-
BioPass™ Pass Through: Seamless Transfers With Built-In Sterilization To Prevent Cross-Contamination
Streamline large equipment transfers with integrated bio-decontamination. This airtight system ensures a log 6 microbial reduction while maintaining strict ISO Class 5 cleanroom integrity.
-
The CC-IS is a Cell Culture Isolator cGMP Class A/ISO 5 system specifically designed to provide the users with a cell culture environment which is safer than environments on traditional biosafety cabinets, clean booths or standard cleanrooms, by eliminating any risk from human contamination of cell cultures.
-
The Thermo Scientific™ Sentinel™ Multiscan Metal Detector utilizes an innovative new technology to overcome the limitation of fixed single or dual frequency metal detectors that can miss metal contaminants hidden in product signals.
-
In the world of pharmaceutical production, high speed truly can be a game changer. The faster you can inspect and produce your medical products, the quicker you can bring them to market, providing people with needed healthcare and seeing a return on your investment. To satisfy this need, we have developed the DE.SY.RE 1000 – the fastest inspection machine in pharma.
-
Elevate production safety with high-speed detection that identifies small contaminants while reducing waste. Intuitive controls and durable design ensure long-term efficiency and reliability.