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Peptide Atlas · Reconstitution liquid

Water for injection

Water for injection is produced under strict microbial control; a risk assessment of membrane-based production identified fouled ultrafiltration membranes, leaking reverse-osmosis membranes and ineffective vent filters as key hazards.

What the evidence says

six tiers, never blended

established — replicated in humans, or settled by a regulator

every claim resolves to its source

All 2 citations resolve to their original source. · 0 posts naming it, 0 members counted once each.

    • established
      Claim: Epidemic of bacteraemia due to contaminated sterile water for injection standing
    • resolved

    An Australia-wide epidemic of Pseudomonas pickettii bacteraemia due to contaminated "sterile" water for injection.

    Roberts LA, Collignon PJ, Cramp VB, Alexander S, McFarlane AE, Graham E, Fuller A, Sinickas V, Hellyar A

    pmid 2198444

    • preclinical
      Claim: Microbial risk management in membrane-based WFI production standing
    • resolved

    Quality risk management for microbial control in membrane-based water for injection production using fuzzy-failure mode and effects analysis.

    Zhu L, Liang Y

    pmid 39896404

A claim's standing is its latest row in an append-only history; a tombstone names the later evidence and the reason. The Graveyard and the Resurrection Yard.

Negative findings

failure is information

Nobody has filed a failure yet. Failures are information; this list is waiting for an honest one.