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Legislation and Standards

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Explore PTI articles, Insights, Know How, and technical publications related to this subject.

  • Co-processed excipient powder sample tested for flow and compaction near a continuous direct compression feed frame
    12 September 2026

    Co-Processed Excipients in Continuous Manufacturing: How Particle Engineering Changes Powder Flow and Compaction Performance

    Co-processing engineers particle morphology, density, and surface structure into a single composite excipient particle. Flow function and compactibility testing show what that buys formulators on continuous direct compression lines, and where it does not.

    Feature Article

  • Technician checking blend uniformity data in a pharmaceutical cleanroom relevant to FDA hub-and-spoke distributed manufacturing rule
    15 August 2026

    FDA’s Proposed Hub-and-Spoke Distributed Manufacturing Rule: What It Means for Blend Uniformity and Granulation Consistency

    FDA's proposed hub-and-spoke registration rule treats geographically separate manufacturing units as one establishment. The registration paperwork is new; proving that blend uniformity, granulation endpoints, and moisture behavior actually match between sites is the older, harder problem.

    Feature Article

  • SAE AIR7359 illustration showing controlled and non-controlled metal powder feedstock properties in additive manufacturing
    8 August 2026

    SAE AIR7359: Why Some Metal Powder Feedstock Properties Are Left Out of AM Specifications

    AIR7359 explains why AMS-AM metal powder feedstock specifications leave certain properties uncontrolled, citing limited applicability and immature standardized inspection methods, and what that gap means for aerospace AM qualification programs.

    Insights

  • Technical illustration comparing how different cosmetic powder particle shapes affect packing and pressed-cake performance.
    18 July 2026

    Preparing for an EU Talc Ban: What Mineral and Starch Alternatives Need to Match

    Talc's expected EU restriction is forcing cosmetic formulators toward mica, kaolin, silica, and starch. None of them reproduce talc's platelet slip, oil absorption, and low dustiness at the same time, and each substitution changes flow and compaction behavior in pressed powder products differently.

    Insights

  • Technical diagram showing Kst explosion index limitations — standardized 20-litre sphere test conditions compared with real industrial vessel geometry and turbulence
    29 June 2026

    Why Kst Is Not Enough: What the Explosion Index Tells You and What It Misses

    Kst quantifies explosion rate-of-pressure-rise under standardized lab conditions. It does not directly describe how an explosion behaves in your vessel, at your turbulence level, or with your ignition scenario. This insight explains what the number means, where the cubic law holds, and when a competent person must go further than the test certificate.

  • Plastic pellet loss prevention diagram showing pellet ejection from a filter receiver and a pellet puff at a diverter valve, with drain protection.
    28 February 2026

    Plastic pellet loss prevention is now a compliance KPI (and a bulk solids design problem)

    Regulation (EU) 2025/2365 makes plastic pellet loss prevention a documented operational control [...]

    Insights

  • Powder data lineage infographic showing a QR coded checklist linking provenance, processing, exposure, and release decisions.
    10 January 2026

    Powder data lineage is now a quality lever, not an admin task

    Powder data lineage is becoming a hard requirement in EU battery and [...]

    Insights

  • Powder containment performance testing during a powder transfer, with an operator handling a liner at a stainless steel connection.
    3 January 2026

    Powder Containment Performance Testing: How to Specify, Measure, and Improve Containment

    Powder containment performance testing turns “we think it’s contained” into measured proof. [...]

    Know How

  • Welding fumes in powder plants captured at the arc with local exhaust ventilation during maintenance welding.
    3 January 2026

    Welding Fumes in Powder Plants: The Hidden Contamination Risk During Maintenance and Hot Work

    Welding fumes in powder plants now sit in a tighter EU compliance [...]

    Insights

  • EU plastic pellet loss regulation, spill containment and vacuum recovery at a pellet transfer point in a bulk handling area.
    20 December 2025

    EU Plastic Pellet Loss Regulation: Bulk Plant Compliance

    EU plastic pellet loss regulation (EU) 2025/2365 makes spill prevention and documented [...]

    Insights

  • titanium dioxide powder classification shown by a tray of white pigment powder with safety documentation
    6 December 2025

    Titanium dioxide powder classification in 2025: what changed, what did not

    titanium dioxide powder classification is shifting again in 2025. An EU court [...]

    Insights

  • PFAS PTFE powder manufacturing cleanroom line with enclosed mixer, coater, and calendaring stack, QA monitor visible.
    18 October 2025

    PFAS vs PTFE in 2025: What’s Really Changing for Powder-Based Manufacturing

    PFAS PTFE powder manufacturing industries will face policy tightening across Europe. PTFE’s [...]

    Feature Article