INSIGHTS ON PHARMACEUTICAL INSPECTION
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Inspecting On The Edge — Understanding Punch Tip Wear
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
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Advancing Drug Product Quality Through AVI And Future-Ready Infrastructure
Automated visual inspection (AVI) combines robotics, precision imaging, and sophisticated defect-recognition software to provide a scalable solution for expanding pipelines and rises in production volumes.
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Why Is It Important To Have Properly Trained Visual Inspectors?
Properly trained visual inspectors are crucial for identifying defects in parenteral drugs, safeguarding patient safety and product quality.
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Selecting Container Closure Systems With Confidence: Lyophilization
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
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Headspace Gas Ingress Methods – The Golden Tool For CCI Testing11/18/2025
Explore headspace method development and validation for complex pharmaceutical systems, with insights into EU GMP Annex 1 compliance, container closure integrity, and ultracold transport validation.
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Supporting GLP-1 And Peptides With Integrated Solutions9/30/2025
Accelerate GLP-1 and peptide therapy development with integrated drug containment, delivery, machinery, and analytics for reliable combination product performance.
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Visual Inspection Of Advanced Therapy Medicinal Products9/2/2025
Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.
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The Critical Role Of Headspace Oxygen Analysis In Stability Studies7/8/2025
Discover how non-destructive headspace oxygen analysis supports stability studies in pre-filled syringes to reveal critical insights into antioxidant saturation and long-term product integrity.
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Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation9/17/2025
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.
PHARMACEUTICAL INSPECTION SOLUTIONS
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Parenteral products, specifically vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.
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Used Mettler Toledo Safeline metalcheck, model 2S, CE rated, 240 volt, serial# 121323, built 2014.
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Learn how these non-destructive inspection technologies verify container closure system integrity with deterministic quantitative test methods for vials, ampoules, syringes, cartridges and auto-injectors.
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At Natoli, we know that quality is paramount. Our cutting‐edge Precision CT Scan Service is designed to detect even the subtlest imperfections in tablets, ensuring you achieve the highest standards of quality every time.
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As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.