Bioburden is the total viable microbial load in or on a product before sterilization or release. We quantify it by USP <61> total aerobic microbial count and total yeast and mold count, with USP <62> specified-organism screening where the specification calls for it. Standard turnaround is 5–7 business days from receipt, and the result comes back on a signed COA you can hand to a customer or an auditor.
Bioburden testing answers a narrow question precisely: how much viable microbial load is present. It is not a sterility test — it is the quantitative measurement that tells you whether your process is in control and whether a sterilization step has enough margin to work.
Any terminal sterilization or sterile filtration step is validated against an assumed incoming bioburden. If the real load is higher than the assumption, the validation does not hold.
Lyophilized peptide powder is not sterile by default. Bioburden quantifies what is actually in the vial before it is reconstituted, which is the number that matters for risk.
Botanical and animal-derived inputs carry high native bioburden from soil and handling. Testing on receipt stops a contaminated lot before it enters your process.
Bioburden results trended over time show whether a cleanroom, a water system, or a fill line is drifting. A single result is a data point; a trend is a quality system.
Purified water and in-process intermediates require periodic bioburden monitoring under USP <1231> and routine cGMP schedules.
Non-sterile finished products need a microbial limits specification with a real number behind it. This is the test that produces that number.
Our $150 bioburden panel includes:
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Send a brief project description — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send a submission form and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) is available for urgent timelines.
Send us your samples and receive a signed Certificate of Analysis. Results in 5–10 business days.