Quality Control

INSIGHTS ON QUALITY CONTROL

Leveraging Integrated Electronic Laboratory Notebook And Inventory Systems
Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development.
Evaluation Of Novel Process Indicators For Hydrogen Peroxide Decontamination
Immediate, quantifiable verification replaces seven-day incubation periods. Discover how enzyme-based indicators optimize hydrogen peroxide decontamination.
Capsule Checkweigher Software Functions
Strengthen data integrity and 21 CFR Part 11 compliance. Discover how advanced software features, automated lot controls, and secure network integration protect your production line.
Ensuring Compliance For Virtual And Hybrid Pharmaceutical Companies
Proactive, risk-based oversight must be established to manage outsourced GXP activities. This requires a robust QMS and comprehensive quality agreements to safeguard product quality and data integrity.

Engineering Controls For Sterile Compounding — USP Requirements And Equipment Selection
7/24/2026

Aligning compounding operations with USP <797> and <800> requires an integrated control strategy. Discover key criteria for cleanroom equipment selection.
Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh
3/19/2026

Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.
Top 10 Things We Wish We'd Known Earlier In Our Biopharma Careers
8/7/2026

Ten hard-won lessons from seasoned biopharma professionals cover the foundational habits, verification steps, and process controls that protect batch integrity and prevent costly deviations.
Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance
7/28/2025

Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
Multi-Lane Checkweigher Overview
6/16/2026

Optimize high-speed lines with compact multi-lane checkweighing that monitors twelve channels on one screen, features detachable conveyors, and prevents product jams.

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.
Minimizing Uncertainty Throughout The Development Lifecycle

Wearable technologies that allow for dosing of high-volume biologics over a longer time need to be designed with manufacturability end-user needs in mind and must comply with the highest quality and regulatory standards.
Process Insight Born Of 45 Years Of Experience

Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.
Cleanroom Pass Through Box: AB-PTC

Tema Sinergie AB-PTC Series is a comprehensive range of Pass Through Box (cGMP Class A/ISO 5) designed for pharmaceutical companies that require an isolated environment for external bio-decontamination of materials prior to their transfer into classified environments.
Restore Control When It Matters Most

Act with certainty during contamination events. Learn a proven four-step process to identify root causes, restore environmental control, and implement effective CAPAs to prevent recurrence.