Quality Control

INSIGHTS ON QUALITY CONTROL

Safety Of Injectables: Ensuring Purity Via Endotoxin Testing
Advance pharmaceutical quality and sustainability by adopting recombinant factor C testing for reliable, animal-free endotoxin detection.
FDA's Risk-Based Inspection Shift: What It Actually Rewards
FDA’s revised pre-approval inspection program prioritizes risk-based determinations over routine site visits. Review risk assessment factors and transition toward continuous audit readiness.
Practical Considerations For Aseptic Gowning In Contamination Control Strategies
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.
Secondary Packaging: Cartoning And Kitting
Fast deployment, scalable production, and rigorous quality control enabled the delivery of over 20 million complex kits in eight months, demonstrating how efficient operations can meet urgent demand.

The Importance Of Container Closure Integrity
9/23/2026

From package design to advanced testing technologies, discover the critical elements of maintaining sterility and preserving product quality over time.
Why Pharmaceutical Regulatory Compliance Software Is Essential For Biopharma Companies
11/13/2025

Establishing a robust, risk-based CAPA system prevents recurring process deviations, satisfies ICH Q10 guidelines, and ensures standing inspection readiness.
Inside The Cleanroom: Building A Culture Of Clean Beyond The CCS Blueprint
2/12/2026

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.
How To Double Up With A CDMO To Reduce Risk
12/12/2025

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.
Accelerating Phase: Supply Without Sacrificing Discipline
8/20/2026

Faster clinical supply delivery starts with the right strategy. Explore how planning, collaboration, communication, and quality systems keep programs on track.

Reliable Solution For Verifying Glove Integrity In Pharmaceutical And Biocontainment Environments

Verify barrier integrity in aseptic environments using standardized pressure loss testing. Ensure repeatable workflows and regulatory compliance with portable, wireless detection technology.
Container Closure Integrity Testing Systems For Vaccines

The pharmaceutical industry continues to bring breakthroughs in the field of new vaccines and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
Quality, Compliance, And Regulatory Services For Life Sciences

The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
Redefining Glove Integrity Testing: Esco IntelliGlove Tester (EIGT)
Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer

Used Perkin Elmer Paragon 1000 PC FT-IR Spectrometer, benchtop design, serial# 38716.