INSIGHTS ON QUALITY CONTROL
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Sterilization Of APIs – The Alternative: Sterile Filtration Following Aseptic Processing
When terminal sterilization isn't an option for heat- or radiation-sensitive APIs, sterile filtration with aseptic processing protects quality. Get the technical framework.
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503A Vs. 503B: Turning Regulatory Complexity Into Practical Compliance
Navigating human drug compounding requires aligning Section 503A and Section 503B operations with cGMP expectations, robust quality management systems, and standing inspection readiness.
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LYO Cycle Development Ensures Success For Oncology Drug Scale-Up
An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.
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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.
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Pharmaceutical X-Ray Counts Capsules & Pills6/15/2026
Learn how advanced X-ray inspection ensures exact pill counts in multi-supplement pouches, automatically identifying missing components and generating time-stamped visual data logs.
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A Closer Look At Multi-Lane Checkweighing In Pharma5/2/2025
Learn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.
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Mastering Material Transfer: Keeping Contamination Out Of Your Cleanroom4/20/2026
Master the nuances of material transfer through expert-led training. Learn to assess packaging integrity, ensure complete disinfection coverage, and manage time-sensitive items with precision.
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Capsule Checkweigher Software Functions6/16/2026
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.
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Curia's Approach To Regulatory Compliance In Korea9/14/2026
Navigating Asian pharma markets requires alignment with local regulations. Standardized documentation, facility registrations, and strong quality systems support compliance and reliable supply.
QUALITY CONTROL SOLUTIONS
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Ensure aseptic integrity with zoned downflow technology. These customizable modules purge contaminants to maintain ISO Class 5 environments for critical filling and research processes.
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Ensure sterile integrity and personnel safety during hazardous drug handling. Optimize workflows with advanced containment technology that adapts to complex facility and processing requirements.
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.
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PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.
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PMS is here to help with all your cleanroom contamination needs.