Expertise
Aseptic processing leaves very little room for error, and even less room for guesswork. We help you design, redesign and validate the processes that keep sterile product sterile.
Whether it's a new aseptic line or an existing process that needs re-evaluating, we work through the process design itself: the interventions, the environment it runs in, and the process validation that has to hold up under scrutiny, including against Annex-1 and cGXP requirements.
Sterility assurance strategy sits close to contamination control, and we treat it that way — the two are usually built together, so your sterility assurance approach isn't undone by a gap in your wider contamination control strategy.
Aseptic process design and process simulation (media fill) strategy
Terminal sterilisation validation (steam, dry heat, radiation, EtO) and the choice of method
Filter validation and bacterial retention testing
Sterility test method validation and suitability testing
Isolator and RABS qualification
Cleanroom and grade A/B environment qualification specific to aseptic operations
Equipment sterilisation cycle development, such as autoclave and depyrogenation cycles
Media fill design, execution and trend analysis
Environmental and personnel monitoring specific to aseptic zones
Sterility test result review and out-of-specification (OOS) investigation
Sterility Assurance Level (SAL) justification and ongoing evidence review
Aseptic technique training and qualification of operators
Intervention risk assessment for planned and unplanned interventions during filling
Behavioural observation and gowning qualification specific to grade A/B work
A passed media fill is often treated as proof that a process is sterile going forward, when it's really a periodic, imperfect simulation with real statistical limitations. Sterility testing gets treated as a release decision that can stand on its own, without accounting for its own statistical limits (small sample sizes, the risk of false negatives) and the need for a wider sterility assurance case around it.
Isolator or RABS technology is assumed to bring risk down to near zero by itself, without the operational discipline (glove integrity, transfer procedures) the technology actually depends on. And a positive result gets investigated in isolation, instead of being cross-referenced against environmental trends, personnel activity and process history to build a genuine root cause case.
Even in a fully qualified grade A environment, it almost always comes down to human interventions: clearing a jam, adjusting a stopper bowl, replacing a component. Each one introduces a moment of elevated risk that's hard to fully engineer away, and few teams comprehensively identify and categorise every possible intervention, planned and unplanned, let alone justify why their frequency and design don't compromise sterility.
Media fill design is another common sticking point: building a simulation that genuinely represents worst-case conditions, rather than an idealised run that passes easily and proves little.
Hands-on support from consultants with direct sterility assurance and aseptic processing experience, not just regulatory theory.
Tell us what you're working on, we'll get back to you with a plan that fits.
