INSIGHTS ON PHARMACEUTICAL INSPECTION
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What Is The Position Of Regulatory Authorities On PUPSIT?
PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.
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Planning For Scale-Up
From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.
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Cryogenic Storage Of IV Bags For Cell And Gene Therapies
Cryogenic storage can compromise packaging integrity for cell and gene therapies. Learn how vacuum decay technology detects micro leaks and ensures product safety under extreme conditions.
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Integrity Testing Of Inhaler Products
Ensuring inhaler integrity is vital for patient safety and regulatory compliance. Discover how Vacuum decay testing provides a sensitive, non-destructive method to detect leaks and maintain sterility.
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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.
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Contamination Control Strategies For Innovation And Regulatory Compliance3/4/2026
Creating a robust contamination control strategy is essential for pharmaceutical manufacturing. Learn to align risk management and technical controls to ensure lasting regulatory compliance.
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M6 Tablet Metal Detector For Pharmaceutical And Nutraceutical Production8/15/2025
Ensure the safety and quality of your tablets and capsules with a metal detector designed for stability and high sensitivity in pharmaceutical and nutraceutical production.
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Discover This X-Ray's Enhanced Detection Capability6/15/2026
Maximize product safety with high-resolution X-ray technology. Discover how advanced sensitivity can detect low-density and fine metal contaminants.
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All Eyes On X-Ray Inspection For Big Box Retailers12/16/2024
Major retailers are mandating x-ray inspection for their suppliers. Uncover why this technology is crucial, and its capabilities beyond contamination detection to encompass vital quality and integrity checks.
PHARMACEUTICAL INSPECTION SOLUTIONS
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Explore the key benefits of a versatile, ergonomic, and award-winning solution for the forming, dosing, and inspection of parenterals.
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The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.
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Explore the wide range of pharmaceutical package applications that can be readily tested by PTI's CCIT Centers of Excellence, from glass and plastic vials to medical devices.
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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.
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This powerful critical control point delivers metal detection, weight control, and label inspection in one, fully integrated and space-saving device. With full configuration flexibility, this system can be designed to match your application needs.