ENSURE ANNEX 1 COMPLIANCE WITH OUR VIRTUAL REALITY SIMULATOR
Are you a manufacturer of sterile products looking to comply with the revised Annex 1 guidelines? Our VR Simulator is the solution you’ve been looking for.
Annex 1: What You Need to Know
The revised Annex 1 (25. August 2023) requires significant adjustments from European manufacturers of sterile products, including training aseptic techniques, understanding fundamental principles, and ongoing assessments for qualification.
Cleanroom personnel must now be trained according to certain principles and the assessment of their performance need to be objective. Sterile manufacturers are faced with the challenge to integrate these new standards and formulate a detailed, facility-specific “Contamination Control Strategy” (CCS). This means that manufacturers need to identify and assess the risk of contamination in their processes and procedures, explore mitigation options, and define preventive actions.
Annex 1: What You Need to Do
Training of Fundamental Principles
Training of Aseptic Techniques
Understanding of Fundamental Principles
Ongoing Assessment of Qualification
Disqualification and Retraining
Achieve Annex 1 Compliance
Preventing human errors in the cleanroom is critical for maintaining the sterility of your product. That’s where our VR simulator training comes in. Our training methodology is founded on psychological insights and supported by state-of-the-art virtual reality technology.
We enable you to train and assess cleanroom operators to Annex 1 compliant, risk-based prevention of human errors. With our simulator training package, you’ll get an in-depth analysis of your process steps and the opportunity to identify and reduce contamination risks.
We enable you to train and assess cleanroom operators to Annex 1 compliant, risk-based prevention of human errors. With our simulator training package, you’ll get an in-depth analysis of your process steps and the opportunity to identify and reduce contamination risks.
Enhance Operator Understanding
Our Simulator raises awareness by visualizing normally invisible elements such as air flow or germs. In this way, your employees can understand critical situations and internalize important cleanroom knowledge.
Our Simulator provides training 24/7 in a risk-free environment with instant accurate feedback on human errors. This way, your operators can train at any time, learn from mistakes and gain confidence with repetition.
Objectively Assess Performance
A neutral and precise evaluation by clear standards is deeply embedded in our Simulator. This way you can easily report and prove your operator performance to regulators.
The objectivity of the system is an advantage. Normally there is a certain subjectivity in the training. With the simulator the judgement on mistakes is transparent, fair and reproducible.
Alexander Stoll
Vice President – Head of Competence Center Microbiology & Aseptic Technique at Fresenius Kabi
Prepare for Annex 1 Now
Don’t wait for warning letters and ensure Annex 1 compliance now! Our VR Simulator makes it easy to train and assess your cleanroom operators, so you can be confident that you’re meeting all the necessary guidelines. Download our Annex 1 Checklist to identify compliance risks or contact us to book a meeting with our experts.
