Sterility

Details

Sterility is the state of having no viable microorganisms; sterilisation is the process that creates that state, and disinfection is treatment that reduces microorganisms — sterility is not proved by finished product testing but assured by a validated process. EU GMP Annex 1 §10.5 treats the finished product sterility test as only the last of a series of critical control measures by which sterility is assured, and states expressly that the sterility of a product that has not met its design, procedural, and validated parameters cannot be assured by that test; §10.6 requires the samples to be representative of the whole batch but to include the parts at greatest risk of contamination, such as the beginning and end of filling, immediately after critical interventions, and the coolest location in a heat sterilised load. Terminal sterilisation aims at a sterility assurance level of 10⁻⁶ or better, and in aseptic processing the aseptic process simulation, environmental monitoring, and intervention control take that place. Inspections cite batch sterility claimed on a passing sterility test alone with a contamination event left uninvestigated, a failing sterility test invalidated as laboratory error without justification, and the absence of the documented test procedure for batches purporting to be sterile required by 21 CFR 211.167(a).

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Specifically, since December 2015, your firm has had numerous sterility failures for batches of BioBurst Fluid and BioBurst Rejuv that you failed to investigate to determine the source of the contamination beyond identifying organisms (for example, a…

   FDA · FDA Warning Letter · 2022-02-22

2. Specifically, you failed to perform appropriate laboratory testing, including sterility testing, on at least (b)(4) batches of the stem cell products derived from adipose tissue, umbilical cord, and bone marrow which are administered intravenously or intrathecally.

   FDA · FDA Warning Letter · 2024-05-28

3. Microbiology Laboratory Data Integrity Your firm failed to test every batch for sterility as required by your procedures.

   FDA · FDA Warning Letter · 2024-07-23

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