INSIGHTS ON QUALITY CONTROL
-
Solutions In Pre-Filled Syringes For Biologics And Ophthalmic Applications
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.
-
The Importance Of Container Closure Integrity
From package design to advanced testing technologies, discover the critical elements of maintaining sterility and preserving product quality over time.
-
Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
-
Shielded BSCs: Regulatory Requirement Or Risk-Based Engineering Solution?
Master the balance between USP <825> aseptic standards and radiation safety. Learn how integrated engineering solutions ensure regulatory compliance while protecting both patients and personnel.
-
Getting Started On A Successful Path To Microbial QC Automation10/6/2026
Moving microbial QC toward automation involves team-building, facility readiness, staff concerns, validation, regulatory alignment, and cost justification that extends well beyond simple labor savings.
-
0.45 m/s ±20% At Working Position In Closed Sterility Testing Isolators: Requirement Or Convention?2/19/2026
Balance compliance and efficiency in sterility testing. Explore how a risk-based approach to airflow and isolator technology aligns with Annex 1 while optimizing contamination control.
-
Building A Culture Of GxP Excellence In 2026—Veeva Training Solutions Podcast4/24/2026
Shift from basic compliance to a strategic GxP culture. Explore how intentional, role-specific training and leadership support reduce risks and improve business outcomes in this video.
-
Solutions For CQA Analysis Of IVT mRNA-Based Biotherapeutics2/20/2025
Discover new innovative solutions for mRNA analysis, enhancing accuracy and efficiency in IVT mRNA workflows, including advanced technologies and methodologies to optimize your research and development processes.
-
Ready To Bring GxP Training To The Next Level? LearnGxP4/24/2026
Upgrade your compliance strategy with accredited, scenario-based GxP training. Eliminate risks like failed inspections and costly deviations with a modern, global solution.
QUALITY CONTROL SOLUTIONS
-
Bioburden testing and microbial limit testing are quality control tests for determining the total number of viable microorganisms of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP, and JP recommendations, ensuring that patients can call upon microbially safe products.
-
The Esco IntelliGlove Tester (EIGT) is Esco’s third-generation wireless glove leak tester, designed for leak detection on gloves, sleeves, and gauntlets used in isolators, RABS, and glove boxes.
-
Flexible, reliable control and bioreactor systems for laboratory applications
Thermo Scientific™ HyPerforma™ bioprocess control systems are designed to optimize your process from the laboratory bench to full cGMP manufacturing. Our innovative control platform combines a flexible operating system with scalable, modular hardware, novel single-use sensors, and state-of-the-art bioreactors for strategic and streamlined bioprocess control.
HyPerforma benchtop solutions offer robust management of both cell culture and fermentation processes. The open architecture provides process flexibility, and dedicated hardware control allows for expansion. Thermo Scientific™ TruBio™ software is designed to support easy process control and scaling.
-
Our solutions have been specified in the testing process for the top two GLP-1 manufacturers
-
Maintain low nanogram containment thresholds during toxic linker compounding. Implement a disposable negative pressure isolation assembly with integrated double-stage exhaust filters.