Research use only · laboratory education · not for human or veterinary use

Method

Sterility, counts, and PCR screens

These words are not synonyms. The certificate should say which one was performed, on what sample, and how long it took.

A sterility test described as USP <71> is a specific compendial method with an incubation, often about 14 days. Laboratories that offer it usually say so, and they often cannot rush it. A preliminary report may be issued with sterility still pending. Read the pending line instead of assuming the final result.

Bioburden and USP <61> describe microbial counts on a material. They are not the same document as a sterility test. TAMC and TYMC are total aerobic microbial counts and total yeast and mold counts: numbers, often pass/fail against a limit, not a 14-day sterility claim. Total yeast and mold as a single test is narrower still.

A PCR sterility screen detects nucleic acid associated with organisms the assay includes. It is faster than a culture method and it is not the same sentence as “USP <71>.” If the certificate says PCR, write PCR in your notes.

Some purity packages state outright that they do not include sterility. That is useful information. Do not fill the blank from a different laboratory’s menu.

None of these results is an instruction for handling a product as if it were a medicine. They are measurements, with the limits of the method that was named.