Quality Assurance

INSIGHTS ON QUALITY ASSURANCE

Scale-Up Of A Transient rAAV Production Process
Scalable rAAV production is achievable with a transient cell line and optimized bioreactor setup, delivering high titers and reduced impurities, now validated at 200 L scale for commercial readiness.
What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)?
Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.
A Data-Driven Approach to Cleaning Validation
Discover how Ongoing Process Verification, guided by PAT and digital integration, ensures consistent cleaning efficacy, reduces risks, and optimizes production efficiency in the pharmaceutical industry.
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.

Advance Traditional CCIT With Dynamic Vacuum Decay
5/22/2026

Dynamic vacuum decay advances traditional CCIT by improving leak detection. Learn how controlled, variable vacuum conditions deliver greater sensitivity and more reliable insight into package integrity.
Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation
9/17/2025

Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
Isokinetic Sampling In Unidirectional Flow
3/5/2026

Accurate cleanroom particle monitoring requires precise isokinetic sampling. Understand how to maintain sampling accuracy and meet regulatory airflow requirements for your facility.
Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications
6/19/2025

Discover how pharma companies can select tailored pre-filled syringes for biologics and biosimilars by aligning drug delivery needs with specialized containers and analytical services.
What Is The Biggest Problem With Inspector Training And Qualification?
8/25/2025

Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.

Rapid Sterility Testing: Actionable Results In Less Than 5 Hours

Use a real-time PCR (qPCR) solution for testing cell therapy products that provides sterility results in less than 5 hours.
Right-First-Time Production Via Quality By Design

Pharma manufacturing is changing fast. Learn how Process Analytical Technology (PAT) empowers real-time process control, boosts efficiency, and ensures compliance.
Connected Execution And Trusted Data For Sponsor-Ready Results

Bioanalytical organizations are responsible for generating accurate, reproducible data that supports development decisions, regulatory submissions and ultimately faster drug approvals. As sample volumes grow and studies become more complex, maintaining quality, compliance and efficiency can become increasingly difficult.
Automatic Filling And Capping Machine In Aseptic Conditions

AseptiFill is the Aseptic Filling and Capping Machine specifically designed for Pharma & Biotech companies, focused on small batch production of injectable products for pre-clinical and clinical trial studies. Suitable for Ready-To-Use (RTU) vials ISO 8362-1 and RayDyLyo^®push-fit caps.
Optimizing Workflow And Compliance With Rapid Transfer

A streamlined transfer approach brings monitoring plates into controlled areas without decontamination delays. With plates kept organized and accessible, teams can maintain productivity.