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.
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.
Summary
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. · pmid:39896404
History
In 1990 an Australia-wide outbreak of bacteraemia was traced to a single contaminated batch of commercially produced water for injection. · pmid:2198444
Proportion of the 2 claims about Water for injection standing at each tier. Community volume is shown on the Consensus tab beside this and is never averaged into it.
Living evidence history
2 resolved citations, oldest to newest, coloured by tier. Retractions and contradictions land here as they are recorded.
Structure
No structure representation on record. PepJunkie draws only what an authoritative record supplies; for a peptide that is the residue sequence, and none has been curated for Water for injection yet.
Dose evidence, rung by rung
A studied human dose exists on file. Open the rung: the dose is the paper's, in its context, never PepJunkie's.
Approved-label dose· a resolved regulatory document names a labelled dose
nothing resolved on this rung
Studied human doses· resolved human studies at the established tier
An Australia-wide epidemic of Pseudomonas pickettii bacteraemia due to contaminated "sterile" water for injection. · pmid 2198444 · 1990
Observational evidence· resolved human data at the emerging tier: thin, or contested
nothing resolved on this rung
Community-reported protocols· protocol propositions from distinct members, counted once per human
nothing resolved on this rung
Preclinical evidence· resolved animal, cell or mechanistic work
Quality risk management for microbial control in membrane-based water for injection production using fuzzy-failure mode and effects analysis. · pmid 39896404 · 2024
2 resolved citations, 0 unresolved (an unresolved citation lends nothing). Community volume is its own rung and is never averaged into the evidence rungs.
Negative findings
failure is information
Nobody has filed a failure yet. Failures are information; this list is waiting for an honest one.