Annex 1 environmental monitoring with fewer interventions
Reduce operator interventions and repeated stops for settle plate changes to stabilize machine availability.
Environmental monitoring for Grade A sterile fill
Grade A viable air monitoring for the full duration, 4-hour plate exposure limits and CCS-based placement of viable and non-viable points raise pressure on aseptic environmental monitoring.
As your strategic lifecycle partner, Syntegon conducts a site-specific risk assessment and automates passive or active and passive viable monitoring with SPC 2000 and SPC 4000 to reduce operator interventions and stabilize availability.
Regulatory compliance, proven automation, real-time detection
How to benefit from long-term microbiological expertise?
Annex 1 expects critical monitoring locations to be determined and justified based on a risk assessment and considered within the site CCS. To meet this, Syntegon applies long-term expertise in microbiological monitoring and particle counting to define viable and non-viable sampling locations and support documentation across the project.
- Risk assessment defines sampling locations for viable and non-viable points
- Critical monitoring locations justified within the site CCS
- Expertise covers multiple monitoring technologies and supplier ecosystems
- Knowledge applied from early project planning through commissioning
How to reach a higher automation degree with proven technology?
Manual settle plate changes force repeated stops and increase contamination risk in the process zone. In response, Syntegon automates viable monitoring with SPC 2000 for passive monitoring and SPC 4000 for active and passive monitoring, replacing routine manual handling with controlled magazine changes.
- SPC 2000 reduces manual interventions by 80%
- SPC 4000 reduces manual interventions by approx. 95%
- Both increase machine availability by up to 300 hours per year
- Retrofit available across all machine brands, types and controls
How to detect deviations faster with real-time monitoring?
Delayed detection of airborne particles prolongs investigations and slows batch disposition decisions. Given this, Syntegon supports real-time environmental monitoring through biofluorescent particle counting, enabling continuous detection of viable and non-viable particles without relying on retrospective plate reads.
- Continuous detection of viable and non-viable airborne particles
- Biofluorescent technology differentiates microbial from non-viable particles
- In-shift signals support faster deviation response
- Supports timely batch disposition decisions
Find the right environmental monitoring solution for your line
SPC 2000
Best if you want:
- Automate passive viable monitoring in existing aseptic lines
SPC 4000
Best if you want:
- Combine active and passive monitoring in one system
Robot-Assisted Viable Air Sampling
Best if you want:
- Automate active air sampling with robotic positioning
Biofluorescent Particle Counter
Best if you want:
- Detect deviations in-shift without retrospective plate reads
See how SPC 4000 automates plate handling
Download to see how SPC 4000 automates active and passive viable monitoring.
- Combine active and passive monitoring
- Cut manual interventions by approx. 95%
- Increase availability by up to 300 h/year
Environmental monitoring built for longer running production
Robotized plate handling in gloveless isolators
Syntegon's Versynta microBatch uses a 6-axis robot inside a gloveless isolator to handle production and monitoring tasks without operator intervention. That reduces human access to the process zone and supports contamination control during aseptic production. Settle plate handling has been developed as a robotic concept on this platform.
- Gloveless isolator with no glove ports required
- No touch transfer as standard container feeding method
- Product contact parts enter via RTPs after VHP bio-decontamination
- Prepared for real-time viable monitoring integration
One system for active and passive viable monitoring
Syntegon's SPC 4000 combines active and passive viable monitoring in one robotic handling unit inside isolators and RABS. That reduces manual intervention and supports a stable monitoring process during production. The functions below show how one system handles both settle plates and the air sampling head.
- Automates active and passive viable monitoring
- Positions the air sampling head for active monitoring
- Handles lockable and non-lockable lids
- Manual interventions reduced by approx. 95%
Real-time detection of viable and non-viable particles
Biofluorescent particle counters use advanced sensors to detect fluorescence emitted by biological particles when exposed to specific wavelengths of light. That enables continuous detection and differentiation of viable and non-viable airborne particles without relying on retrospective plate reads. Syntegon integrates real-time viable monitoring on isolated fillers to support in-shift deviation response.
- Continuous detection of viable and non-viable airborne particles
- Differentiates microbial from non-viable particles by fluorescence
- Removes reliance on retrospective plate read results
- In-shift signals support faster deviation response
Settle Plate Changer footprint
The SPC requires minimal space and provides a compact, space-saving solution for your passive viable monitoring process.
Request your free footprint templates to check the space requirements in your specific machine.
In addition to the standard configurations, other layouts are possible after consultation with us.
Environmental Monitoring knowledge hub
SPC 2000 flyer
Learn how automated passive EM cuts interventions and improves availability in aseptic lines.
SPC 4000 flyer
See how one system combines active and passive viable monitoring with fewer interventions.
Frequently asked questions
Sedimentation plates may be exposed to cleanroom air for a maximum of 4 hours. In running production, that means the machine must stop every 4 hours for a manual plate change unless handling is automated. Repeated stops increase contamination risk and reduce machine availability.
SPC 2000 automates passive viable monitoring. SPC 4000 automates active and passive viable monitoring in one system. Both integrate in isolators and RABS, support lockable and non-lockable lids, and are available with new machines or as retrofit solutions across all machine brands, types and controls.
Automated plate handling replaces repeated manual settle plate changes during production. SPC 2000 and SPC 4000 extend change intervals to a minimum of 24 hours and stop only for magazine changes. Both increase machine availability by up to 300 hours per year.
Yes. SPC 2000 and SPC 4000 are available as retrofit solutions for all machine brands, types and controls. Both also offer standardized interfaces for exposure data transfer, and barcode scanning is available as an option for stronger traceability.
Biofluorescent particle counters use advanced sensors to detect fluorescence emitted by biological particles when exposed to specific wavelengths of light. That enables continuous detection and differentiation of viable and non-viable airborne particles during production without relying on retrospective plate reads.
Consider one system when the process requires both active and passive viable monitoring. SPC 4000 combines both modes in one robotic handling unit inside isolators and RABS and reduces manual interventions by approx. 95%, supporting a stable and reliable monitoring process during production.
Interested in automating your viable monitoring process through the Settle Plate Changer?
News
Discover Syntegon’s seamless pharma solutions at PACK EXPO 2026 in Chicago – from vial fill-finish and Annex 1 compliance to flexible OSD production.
Discover how Syntegon barrier systems support Annex 1 compliance, reduce contamination risks, and enable safe aseptic filling processes.
Our experts look forward to welcoming you at booth 9A50, where you can experience our seamless solutions and services for liquid and solid pharmaceuticals.