Sterile Product Manufacturing Guidelines
In sterile product manufacturing, staying compliant with global regulatory guidelines is not optional – it’s essential. From GMP Annex 1 to FDA aseptic processing guidance, contamination control is at the heart of modern pharmaceutical manufacturing.
Far-UVC (222 nm) offers a breakthrough in continuous disinfection that aligns with the latest regulatory focus on proactive contamination control – especially in cleanrooms and critical Grade A/B environments.
-w-operator-w-shadow.png?width=542&height=600&name=UV222-Booth%2BStep-On-(integrated)-w-operator-w-shadow.png)
Regulatory Compliance & Far-UVC
Align with Global Guidelines:
-
GMP Annex 1 (EU): Emphasizes contamination control strategies (CCS) and continuous disinfection in aseptic areas.
-
FDA Guidance: Requires advanced environmental monitoring and control in sterile product manufacturing.
Far-UVC supports both by enabling continuous air and surface disinfection – without posing a threat to human exposure.
Why Far-UVC for Sterile Manufacturing?
Safe for Occupied Spaces: Far-UVC at 222 nm doesn’t penetrate skin or eyes – making it ideal for environments where personnel are present.
Continuous Disinfection: Unlike manual cleaning or periodic UV-C, Far-UVC works around the clock.
Validated Efficacy: Proven to inactivate bacteria, spores, and viruses – including drug-resistant strains.
Applications in Cleanrooms & Sterile Environments
-
Grade A/B Cleanrooms
-
Filling lines and isolators
-
Airlocks & transfer zones
-
High-risk zones requiring real-time control
Deploying Far-UVC in these environments supports your CCS and enhances sterility assurance.
About UV Medico
UV Medico is a leading provider of certified Far-UVC lighting solutions tailored for pharma and biotech environments. Backed by clinical research, our solutions are already helping manufacturers meet compliance goals while reducing risk.
Looking for products to fit into your existing structure?
UV Medico has a wide range of products suitable for Cleanrooms and the Pharmaceutical industry.
Latest Cleanroom related articles
3 min read
Far-UVC and ISO 14644 Compliance in Cleanrooms
Mar 14, 2025 by Jordi Amagat Molas
2 min read
New Study Highlights UV222 Lamp in Safe Pathogen Inactivation
Feb 27, 2025 by Ping Hu
4 min read
Environmental Monitoring in Cleanrooms: Enhancing Product Safety with Far-UVC at 222 nm
Feb 13, 2025 by Rasmus Bakholm Pedersen
Looking to enhance your contamination control strategy?
Discover how Far-UVC and our UV222 products can help you meet Annex 1 standards, lower bioburden, and seamlessly integrate into your current Contamination Control Strategy.