Microbiological QC LIMS for sterility, endotoxin, and bioburden
USP 71, 61, and 85 testing plus rapid methods, microbial ID, and mycoplasma, with incubation tracking, media lot genealogy, and results linked to the batch.
Microbiological QC LIMS for sterility, endotoxin, and bioburden
USP 71, 61, and 85 testing plus rapid methods, microbial ID, and mycoplasma, with incubation tracking, media lot genealogy, and results linked to the batch.
THE PROBLEM
Micro QC is the long pole in batch release. A 14-day sterility test means 14 days of daily reads, isolator sessions, and media lot tracking, and every read has to be documented by someone at a specific time. Miss one and the test is questionable.
Endotoxin brings its own math: maximum valid dilution, inhibition and enhancement, and kinetic curve acceptance. Rapid methods promise to shorten the wait but only if the result flows into the record the moment it’s captured. Otherwise the faster read still waits on the same manual logging step sterility testing does, and the speed advantage is lost before it reaches the batch record.
Labbit schedules and captures every read, tracks media and reagent lot per test, calculates MVD and evaluates LAL curves inside the workflow, and pulls rapid method results in as they complete. The batch record sees micro status in real time rather than at day 14.
PRE-CONFIGURED WORKFLOWS
Built visually in BPMN, adapted to your lab, and changed without a vendor release.
Instruments and platforms
Does Labbit schedule and capture sterility test reads?
Yes. Daily reads are scheduled per test, captured with operator and time, and isolator session and media lot are tracked for the full 14 days.
Is endotoxin testing on Endosafe and WinKQCL integrated?
Yes. Charles River Endosafe and Lonza WinKQCL integrate with MVD calculation and inhibition and enhancement tracking built in.
Does Labbit support rapid micro methods?
Yes. Growth Direct and BACT/ALERT results flow into the record as they complete, shortening time to release decision.
Can Labbit replace 28-day mycoplasma culture with rapid qPCR?
Yes. Validated NAT mycoplasma workflows on QuantStudio and cobas are pre-configured for short shelf-life products.
SEE IT ON YOUR ASSAYS
Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.