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Residue Management for Cleanrooms
Reduce costs with Ecolab’s low residue program Learn morePeer reviewed article
Use of Conductivity as a Tool for On‑site Residue Management and Definition of Smart Cleanroom Regimes.
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The importance of residue management
Disinfectant residues impact many areas of the cleanroom. Additionally, increasing regulatory demands around residues mean life sciences cleanroom managers need to have a residue management strategy in place for their facilities.
The recent updates to Annex 1 require that a cleaning process should be validated to ensure the removal of residues and any subsequent consequences from them, e.g. the effect on environmental monitoring results or disinfectant, as applied. However, the challenge for any pharmaceutical manufacturer is how to accurately quantify residue levels.
" For disinfection to be effective, prior cleaning to remove surface contamination should be performed. Cleaning programmes should effectively remove disinfectant residues."
Eudralex Vol 4. Annex 1, 4.33
Ecolab Life Sciences has developed an innovative method for residue measurement and comparison, including visual appearance, Residue on Evaporation (RoE) and residue accumulation. This three phase approach clearly demonstrates the differences between different products on both first and multiple further applications.
In order to minimise residues and their build up, Ecolab Life Sciences’ range of low residue products offer cleanroom managers a less disruptive approach to controlling residues as part of the cleaning and disinfection process.
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This approach is designed to:
Ease Regulatory Compliance
No sticky or slippery surfaces caused by residues, reducing accidents and operator acceptance
Reduce Safety Risks
Scrutiny of residue management has increased due to implematation of Annex 11
Increase Productivity
Reduce rinsing time by up to 80%, saving up to 5% of effective production time2
Reduce Operational Cost
Total process cost reduction, minimising the chance of an inspection shutdown
Ecolab Klercide Residue Comparison Time Lapse
Ecolab has developed a range of low residue products which are proven to reduce residues on both initial application and on repeated applications3. Klercide Low Residue Quat, for example, can be applied up to 10 times with less residue accumulation than even one application of other standard disinfectants.
- EU GMP Annex 1 Manufacture of Sterile Medicinal Products (2022)
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