Good airflow is not enough
Under the revised EU-GMP Annex 1, in force since 25 August 2023, airflow visualisation is an explicit requirement in the qualification of cleanrooms, isolators, RABS and aseptic filling lines.
But good airflow alone is not enough: Annex 1 requires the video recordings of the study to be retained, and that video is what the inspector will watch.
The study must therefore be designed and performed so that airflow patterns are clearly readable. It must also document the operating conditions and interventions that may affect the protection of exposed areas and products.
When study design or filming quality falls short, several issues can arise:
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scenarios not fully covered, including operating conditions, interventions or critical points;
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airflow patterns that are hard to interpret due to poor lighting, contrast, smoke density or camera settings;
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operator interventions documented only partially, or with framing that doesn't allow a complete reading;
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the need to repeat the study or supplement the documentation, with possible impacts on qualification and validation activities and on production planning.
What a complete Smoke Study requires
An effective Smoke Study cannot be improvised in the field. It requires a combination of aseptic process knowledge, GMP requirements and filming expertise. Every study should be designed through structured, risk-based planning that includes:
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studies both at rest and in operation;
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full coverage of inherent and corrective interventions, door openings and critical points;
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multi-camera filming from multiple angles, including from inside isolators and RABS when needed;
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lighting, contrast and backgrounds designed to make the smoke clearly readable.
Smoke Studies are our craft
For Zeroframe, Smoke Studies are not just one service among many. We have been performing them since the late 1990s, when they were still a pioneering practice in Italy.
In nearly thirty years of activity, we have recorded more than 5,000 hours of footage and documented over 100 cleanrooms. This experience has allowed us to develop an approach that combines filming technique, aseptic process knowledge and GMP expertise.
More than filming: GMP expertise and technical consulting
We started out as professional filming specialists. Over the years, we have built specific expertise in controlled-contamination environments, aseptic processes, GMP requirements and qualification activities.
That's why we don't just do the filming. We support Production, Quality Assurance, Validation and Engineering teams throughout every phase of the study, from design to final documentation.
The result is a single partner that brings together regulatory expertise, process knowledge and multi-camera filming technique.
Let's meet at CPHI Milan (6–8 October 2026)
We won't have a booth: we meet companies by appointment.
Are you planning a qualification or requalification? Write to us at info@zeroframe.it with the subject "CPHI 2026", telling us your preferred day and time. We'll get back to you to schedule the meeting.
Regulatory references
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EU GMP, Annex 1 – Manufacture of Sterile Medicinal Products (2022), sections 4.15, 4.20–4.21 and 4.25
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FDA, Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice (2004)
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ISO 14644-3, Cleanrooms and associated controlled environments – Test methods
