Aseptic Process Simulation (APS, Media Fill)

Details

An APS uses a growth medium to simulate all critical steps, interventions, shifts, and worst case conditions of the routine aseptic process, and so assesses whether the process can be carried out aseptically. Inspections cite omission of genuine interventions and inadequate incubation, growth promotion testing, investigation of contaminated units, or requalification of personnel. Check the APS protocol, video, and batch record, the intervention list, incubation and growth promotion results, failure investigations, and personnel qualification records.

Related sections

Related terms

Real inspection findings

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

1. One critical deficiency was raised: 1) Failure to investigate and assess product impact in the deviations including deviations related to Aseptic Process Simulation (APS) failure and environmental monitoring excursions in grade A/B cleanrooms.

   EMA · EU GMP NCR (EudraGMDP) · 2026-06-12

2. Regarding your Aseptic Process Simulations, batch records reveal that each operator is required to fill a minimum of (b)(4) units, however, during production an operator can fill up to (b)(4) units.

   FDA · FDA Warning Letter · 2025-03-11

3. Regarding the failure to conduct aseptic process simulation (“media fills”) under the most challenging, stressful conditions, your response indicates you will perform media fills that more closely correlate with the (b)(4) batch sizes.

   FDA · FDA Warning Letter · 2022-09-13

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.