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Annex 1 environmental monitoring with fewer interventions

Reduce operator interventions and repeated stops for settle plate changes to stabilize machine availability.

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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?

Apply risk-based monitoring knowledge to every machine project.

How to reach a higher automation degree with proven technology?

Automate passive or active and passive viable monitoring with SPC 2000 and SPC 4000.

How to detect deviations faster with real-time monitoring?

Monitor viable and non-viable particles continuously during aseptic production.

Find the right environmental monitoring solution for your line

Overall 4 Solutions
Monitoring mode
Handling concept
Integration fit
Manual intervention impact
Change interval or runtime
Retrofit or deployment scope
Data and traceability
Benefits
spc-2000
SPC 2000
Monitoring mode
Passive viable monitoring
Handling concept
Magazine and gripper automate settle plate exchange
Integration fit
Isolators and RABS
Manual intervention impact
Manual interventions reduced by 80%
Change interval or runtime
Minimum 24-hour plate exchange interval
Retrofit or deployment scope
New machine or retrofit across all brands, types and controls
Data and traceability
Standardized exposure data transfer, optional barcode scanning
Benefits

Best if you want:

  • Automate passive viable monitoring in existing aseptic lines
SPC_4000_front_solo
SPC 4000
Monitoring mode
Active and passive viable monitoring
Handling concept
Magazine and gripper automate settle plate and air sampling head handling
Integration fit
Isolators and RABS
Manual intervention impact
Manual interventions reduced by approx. 95%
Change interval or runtime
Minimum 24-hour plate exchange interval
Retrofit or deployment scope
New machine or retrofit across all brands, types and controls
Data and traceability
Standardized exposure data transfer, optional barcode scanning
Benefits

Best if you want:

  • Combine active and passive monitoring in one system
mhd-robot-detail
Robot-Assisted Viable Air Sampling
Monitoring mode
Active viable air sampling in the process zone
Handling concept
Robotic positioning of the air sampling head during production
Integration fit
Aseptic production environments
Manual intervention impact
Reduces manual sampling access in the process zone
Change interval or runtime
Defined by sampling schedule
Retrofit or deployment scope
Dependent on-site configuration
Data and traceability
Sampling data transferable to higher-level systems
Benefits

Best if you want:

  • Automate active air sampling with robotic positioning 
Biofluorescent-Particle-Counter
Biofluorescent Particle Counter
Monitoring mode
Real-time viable and non-viable particle detection
Handling concept
Continuous airborne particle sensing with no plate handling required
Integration fit
Aseptic production environments
Manual intervention impact
No routine plate changes required
Change interval or runtime
Continuous operation during production
Retrofit or deployment scope
Dependent on-site configuration
Data and traceability
Real-time particle data with in-shift deviation signals
Benefits

Best if you want:

  • Detect deviations in-shift without retrospective plate reads 

Environmental monitoring built for longer running production

microbatch-mbf

Robotized plate handling in gloveless isolators

Automate monitoring in a gloveless robotic production cell.
spc-2000-square

One system for active and passive viable monitoring

Cover both monitoring modes with one handling unit.
alf-5060

Real-time detection of viable and non-viable particles

Identify microbial and non-viable particles continuously during production.
Flyer_SPC_2000_2 (1)
Highlight Topic

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.

Your strategic lifecycle partner for environmental monitoring

service-life-cycle
Ready for everything, from start to routine

From installation to optimization, Syntegon supports you with structured service packages, training, and specialists – for safe, stable and resilient production across the lifecycle.

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service-life-uptime
Secure availability – every day

Fast spare parts, qualified support and preventive maintenance help you avoid unplanned downtime, protect performance and keep daily operations reliable.

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service-future-ready
Make your line fit for tomorrow

Scalable retrofits, data solutions and handling/automation systems help you adapt to new demands, improve OEE and keep your lines future-proof across changing requirements.

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Environmental Monitoring knowledge hub

SPC 2000 flyer
SPC 2000 flyer

Learn how automated passive EM cuts interventions and improves availability in aseptic lines.

SPC 4000 flyer
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?

Interested in automating your viable monitoring process through the Settle Plate Changer?

 

Request a quote.

 

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