Our history

A journey that began in the 1990s and has now become the technical standard for Smoke Studies

Our History

A Technical Advance Which Has Kept Pace With Regulations

Since initial experiments with video in the 1990s, ZeroFrame has kept pace with, and often pre-empted, regulatory developments in the pharmaceutical field. Every technical development has been an advance in terms of more effective, legible documentation usable in audits and inspections. Today we work with proprietary technology, dedicated teams and know-how developed on complex systems and machines throughout Europe.

Our History - A Technical Advance Which Has Kept Pace With Regulations
1992 - Early Developments
1992

Early Developments

Luca Busi shot the first video footage in controlled environments with manual vials and stage lighting.

2002 - The First Creative Solutions
2002

The First Creative Solutions

Introduction of contrasting backgrounds to improve smoke visibility.

2007 - Regulatory References
2007

Regulatory References

Publication of the first Annex 1: smoke tests become part of European guidelines (EU-GMP).

2014 - Evolution of Smoke Traces
2014

Evolution of Smoke Traces

Adoption of WFI water-based foggers, which are more suitable for sterile environments than oil-based ones.

2015 - More Sets of Eyes
2015

More Sets of Eyes

Introduction of a multicamera system (four video cameras) with synchronised recording.

2017 - Advanced Support
2017

Advanced Support

Addition of technical graphics in support of the framing and positioning of the smoke traces.

2019 - Growth in the Field
2019

Growth in the Field

Establishment of multiple teams working in parallel.

2020 - Editing Department
2020

Editing Department

Creation of a dedicated post-production team for visual optimisation of the footage.

2022 - New Requirements
2022

New Requirements

Revision of Annex 1: the guidelines explicitly require airflow visualisation studies to demonstrate the correct design and approval of systems, differential pressures and operating conditions.

2023 - Dedicated Set-Ups
2023

Dedicated Set-Ups

Development of new solutions for the precise positioning of cameras and foggers.

2024 - Targeted Engineering
2024

Targeted Engineering

Design of personalised nozzles to reduce the impact on the air flows.