INSIGHTS ON QUALITY ASSURANCE
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Device Design For Usability And Risk Reduction
Growing use of large‑volume subcutaneous therapies is increasing demand for wearable injectors that reduce user error, simplify preparation, and enhance safety through human‑factors‑focused design.
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Get More From Less: AMP Chemistry Outperforms Hybrid Capture
Sequencing performance can drop quickly with low-quality, low-input FFPE DNA. Gain insight into how one approach helps labs minimize repeats and maintain more consistent results.
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HPAPI Containment: A Full Lifecycle Safety Innovation
Containing highly potent APIs across a full operational lifecycle requires a structured approach that addresses hazard scoring, quality by design, performance testing, and safe enclosure disposal.
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How To Use Enzyme Indicators In An Aseptic Production Environment
Discover how transitioning to quantitative validation data allows engineering teams to optimize decontamination timelines, slash system downtime, and minimize product carryover risks.
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Why Requalify?4/14/2026
Qualification is not a one-and-done activity in regulated environments. Learn when requalification is required and how lifecycle-based testing helps ensure equipment performance and compliance.
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Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation5/15/2025
Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.
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Remote Measurements For Bulk Samples12/29/2025
Remote Raman spectroscopy enables accurate material identification at long distances without complex focusing. Learn how pathlength, sample properties, and substrate choice impact signal quality.
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A New Standard For Production Efficiency And GxP Compliance4/20/2026
Traditional MES platforms were built for stable environments that no longer exist. Manufacturers are now adopting composable execution architectures to reduce friction and adapt faster.
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Best Practice Approaches To Operational Readiness12/11/2024
Learn how to implement a focused operational readiness model that goes beyond traditional construction and startup schedules. Discover how this approach can reduce timelines and improve project success.
QUALITY ASSURANCE SOLUTIONS
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The primary characteristic of Containment Isolators is maximizing operator protection: Tema Sinergie Containment Isolator systems have been designed for handling high potent compounds and offer guaranteed very high levels of user protection.
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The Esco IntelliGlove Tester (EIGT) is an advanced glove integrity testing solution designed for pharmaceutical, biocontainment, and aseptic manufacturing environments where consistency, traceability, and regulatory compliance are essential.
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V11 Label Inspection System
Adaptable, integrable, and cost-effective. This flexible label inspection solution reliably inspects oriented products from the sides or top for label data and quality defects. It can be easily integrated into existing production lines utilizing smart cameras, lighting, and software.
100% Automated Label Inspection
Affordable vision system ideally suited to replace manual spot checks with 100% automated label inspection control for high-speed production lines.
Compliance Support
The V11 provides documented label inspection in line with industry guidelines such as IFS and BRCGS to support consumer safety.
Prevent Recalls and Reduce Waste
The V11 verifies labels to detect and reliably sort non-conforming products. False or missing declarations often lead to costly recalls.
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Learn how automated glove integrity testing helps isolator and RABS teams improve compliance and simplify traceability with precise leak detection, RFID tracking, and connected workflows.
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Professional installation and qualification services start and keep your Cytiva equipment compliant, from day one to retirement.