Quality Control

INSIGHTS ON QUALITY CONTROL

A Decision Focused Guide To Contamination Control From Design To Opening
Stop treating contamination control as a late-stage detail. Learn how making early, intentional design choices prevents startup delays and ensures your new cleanroom is ready for inspection.
Manufacturing Solutions
Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.
Physical Contamination Detection
Learn how physical contaminants enter production lines and how detection systems like metal detection and X-ray inspection help prevent defects and recalls to strengthen quality control.
Capsule Checkweigher Weigh Cell
Examine these internal component updates and see how modular scaling optimizes mass-inspection tasks. Achieve consistent weight accuracy on high-speed pharmaceutical lines with this checkweigher.

Minimizing Particulate Risk
5/13/2026

While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.
Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
12/9/2024

21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
Practical Considerations For Aseptic Gowning In Contamination Control Strategies
2/26/2026

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.
ISO/TR 14644 -21:2023 Cleanrooms And Associated Controlled Environments — Part 21: Airborne Particle Sampling Techniques.
3/5/2026

Avoid common sampling errors and ensure cleanroom compliance. Master correct probe placement and tubing configurations to align with the latest industry standards and improve data accuracy.
A Guide To Scale-Up And Purification For Small, Large Molecules
4/13/2026

Advance your separation and purification strategies by leveraging modern industrial chromatography approaches that scale reliably from lab to production across small-molecule and biologics manufacturing.

The Business Case For Electronic GxP Management

Spreadsheet-based quality systems carry costs that tend to be underestimated. Electronic GxP management shifts effort from routine compliance tasks toward quality improvement and patient safety.
Container Closure Integrity Of Parenteral Products

The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
Accelerate Development With Our Non-GMP Small Scale Lab

Mikart’s small-scale non-GMP lab accelerates development by enabling rapid testing and iteration at a lower cost.
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.
High-Risk Package Integrity Testing Systems

The ongoing R&D of PTI continues to build a powerful set of leading-edge inspection technologies that will bring patented and unique solutions to high risk packaging applications. There is continuous development in the field of creating new test methods for container closure integrity, seal integrity testing and package integrity testing.