Container Closure Integrity (CCI)

Details

CCI is the last physical barrier that keeps a product sterile and of the intended quality from sterilisation until the point of use. Inspections cite weak sealing process validation, sampling that is not statistically sound, and unverified effects of transport, reduced pressure, and extreme temperature, as well as missing verification at stability time points. Look at the container and closure specification, validation of the sealing process and the test method, transport and stability CCI results, and complaint and recall trends.

Related sections

Related terms

Real inspection findings

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

1. The site fails to demonstrate full control of the manufacturing process of Janssen’s viral vector drug substance with repeated contamination issues as well as a history of cross contamination with another viral vector vaccine drug substance.

   EMA · EU GMP NCR (EudraGMDP) · 2022-04-01

2. Suspension or voiding of CEP (action to be taken by EDQM) CEP 2021-360 / Biperiden hydrochloride, CEP 2020-317 / Biperiden hydrochloride were suspended by EDQM December 25, 2024, and CEP 2022-168 / Sumatriptan succinate application was closed.

   EMA · EU GMP NCR (EudraGMDP) · 2025-01-13

3. Examples of microorganisms identified in your cleanroom include Bacillus species non-anthracis, Fictibacillus species, Bacillus pumilus , Gram Positive Cocci, fungi, and Bacillus megaterium .

   FDA · FDA Warning Letter · 2022-09-20

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