Expertise
Contamination in a production process rarely announces itself, until it shows up in a result you can't explain. We find where it comes from, and help you close the gap before it becomes a recurring finding.
We start with the source, tracing contamination back through the process rather than treating each excursion as a one-off. That means looking at people, materials, equipment and environment together, and building a contamination control strategy that reflects how your site actually operates, not a generic template.
When something does go wrong, we help with the investigation itself: risk and GAP assessments, root-cause analysis, and the CAPA's and change control that follow. The aim is always the same — a strategy your team can keep running once we're gone, not a one-off fix.
A defensible CCS pulls together four things that are too often handled separately.
Risk assessment of the sources, routes and receptors of contamination
Building and maintaining the Contamination Control Strategy itself
Periodic review, trend analysis and continuous improvement
Cleanroom classification and qualification (ISO 14644), including airflow and pressure cascades
The utility systems that affect bioburden (WFI, purified water, compressed air/gas)
Cleaning and disinfection validation, including disinfectant efficacy testing and rotation strategy
Designing the environmental monitoring programme across air, surfaces, personnel and water systems
Microbial identification and trending, including excursion investigation
Deviation management and root cause analysis
Gowning qualification and personnel flow
Training, competency assessment and aseptic behaviour on the floor
A classified cleanroom or a validated cleaning procedure often gets treated as a guarantee, when it's really one control among several. Environmental monitoring data becomes a box to tick rather than a live signal: trends get filed instead of read, and drift goes unnoticed until it's an excursion. Personnel behaviour is usually the biggest variable in the room, yet gets the least structural attention. And a CCS written once for an audit stops reflecting reality the moment your process, product or facility changes around it. “No growth detected” is not the same as “no risk present.”
Most of the time it's a contamination event or an environmental monitoring excursion that makes “are we actually in control?” a very concrete question. Just as often it's an upcoming inspection, or the findings from a recent one, especially where gaps surface against the updated EU GMP Annex 1, which now effectively requires a formal, documented CCS.
Physical change drives the same conversation: a facility expansion, a new cleanroom or production line, a move into a more regulated space, or two quality systems that need to be harmonised after a merger. Occasionally it starts outside the building altogether, with a customer complaint that traces back to contamination in the product.
Usually project-based, working alongside your quality and production teams on-site, so the strategy is embedded in your team, not locked in a report.
Tell us what you're working on, we'll get back to you with a plan that fits.
