The monoclonal antibody production line requires a microbial load of ≤ 1 CFU/25 cm ², and traditional contact plates require 48 hours, which cannot cover dynamic monitoring of grades A and B. The ATP fluorescence detector provides real-time RLU readings and can complete risk release within 30 minutes after equipment assembly, batch conversion, and environmental deviation.

Scheme design:

• Key control points: chromatography column interface, ultrafiltration membrane package bracket, sterile connector, filling needle;

• Sampling strategy: wipe every point vertically and horizontally at 25 cm ², with a minimum of 30 points per batch;

• Judgment criteria: RLU ≤ 20 for A-level areas, ≤ 80 for B-level areas, and ≤ 200 for C-level areas;

• Data management: Level 4 permissions, electronic signatures, audit trails, compliant with EU GMP Annex 1 2023.

18 month verification shows:

• Correlation coefficient with MAS-100 planktonic bacteria sampler r=0.951;

• The deviation investigation time has been shortened from 3 days to 4 hours;

• The sterile assurance level has been improved by 2 orders of magnitude.

ATP fluorescence detectorBuilt in 6 sets of shortcut programs, capable of storing different products and different levels of limit values; The swab tube can be sterilized at high temperatures and reused to reduce the risk of biological load.