INSIGHTS ON QUALITY CONTROL
-
LYO Cycle Development Ensures Success For Oncology Drug Scale-Up
An optimized lyophilization cycle removes excess moisture during scaleāup by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.
-
Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint
Achieving sterile excellence requires more than just rigid protocols. Learn how to foster a proactive mindset across your entire organization to ensure long-term facility integrity.
-
Detection And Quantification Of Amorphous Content In Materials
Complementary analytical techniques like DSC, MDSC, cRHp, DVS, and SolCal accurately quantify amorphous content in pharmaceuticals to ensure stability, compatibility, and efficiency.
-
How To Double Up With A CDMO To Reduce Risk
Parallel operations with a CDMO can reduce risk and accelerate timelines by enabling simultaneous process development and manufacturing. Learn how this approach supports facility design.
-
Practical Considerations For Aseptic Gowning In Contamination Control Strategies2/26/2026
Master the complexities of aseptic gowning and Annex 1 compliance. Explore risk-based strategies to mitigate human-source contamination and strengthen your facility's sterility assurance.
-
Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
-
Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Application Note3/6/2026
Maintaining high-quality water for injection is essential for pharmaceutical safety. Discover how strategic design, proactive maintenance, and risk-based monitoring ensure reliable results.
-
A Powerful Non-Destructive Tool For Tablet Characterization10/6/2025
Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.
-
A Closer Look At Multi-Lane Checkweighing In Pharma5/2/2025
Learn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.
QUALITY CONTROL SOLUTIONS
-
What is dissolution testing? Why is it critical? What should you consider for your method validation? Find answers to these questions and more in this quick guide to dissolution testing.
-
The Aseptic Filling Isolator is a custom-designed cGMP Class A/ISO 5 isolator system specifically designed for batch scale pharmaceutical production of injectable products for pre-clinical and clinical trial studies.
-
PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
-
Safeguard your cleanroom environment with secure material transfer solutions. Interlocking pass boxes prevent cross-contamination and maintain critical sterility during item transit.
-
Discover the advantages of an intuitively simple HPLC system developed specifically for biopharmaceutical quality control laboratories.