The Contamination Control Strategy (CCS) approach will continuously identify, scientifically evaluate, and effectively control potential contamination risks to product quality. To assess the risks of non-sterility a contamination control strategy is prerequisite of process and system. This will include an assessment, acknowledgement, and remediation process for contamination risks from potential extraneous sources of endotoxin/pyrogen, particulate and microbial contamination such as personnel, materials, and the surrounding environment, and assist in the rapid detection of potential contaminants in the environment and the product.
For pharmaceutical manufacturers and their suppliers, contamination of any kind that leads to product or production losses represents a significant risk. As recent events in the past, such as foreign particulate contamination (https://www.fiercepharma.com/pharma/contaminant-moderna-covid-19-vaccine-vialsfound-japan-was-metallic-particles-report), have shown, this can lead to supply bottlenecks for individual medicinal products or groups of medicinal products. Manufacturers should design their production facilities, equipment, and processes and implement Quality Risk Management (QRM) to ensure appropriate contamination control to minimize or detect contamination. (2) A holistic view is proposed in revised EU Annex 1 Aug_2022 for particulates, microbial, and pyrogen contamination.
The recent revised EU-Annex-1 elaborates various updated expectations on cleanroom cleaning, disinfection, and decontamination. Before moving ahead, let us know the expectations defined in EudraLex Volume 4, Annex-1, Aug-2022.
Cleaning: A process for removing contamination, e.g., product residues or disinfectant residues.
• The combined strategy of the CCS should establish robust assurance of contamination prevention.
• Contamination control and steps taken to minimize the risk of contamination from microbial, endotoxin/pyrogen and particle sources includes a series of inter-related events and measures.
• Potential sources of contamination are attributable to microbial and cellular debris (e.g. pyrogen, endotoxin) as well as particulate (e.g. glass and other visible and sub-visible particles).
As specified in various sections 2.5 (xiii), 4.6, 4.33, 4.7, 4.12, 8.47 & 8.49 cleaning and disinfections are described as key element of CCS with following considerations:
As specified in various sections 2.5 (xiii), 4.6, 4.33, 5.4, cleaning is described as key step of CCS with following considerations:
As specified in section 4.34, “the disinfection process should be validated”, which should include now,
The author of this article, Karan R Khairnar is Global Technical Consultant Manager – Life Sciences, ECOLAB