Sterile Monitoring Kiosk

Real-Time Insight Into Invisible Risk.

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The Sterile Monitoring Kiosk (SMK) is an automated, closed-loop environmental and personnel monitoring system designed to eliminate non-value-added human presence in aseptic manufacturing areas. The system replaces manual petri dish handling, gown sampling, and routine environmental rounds with robotic sampling, automated kiosks, and near-real-time contamination analytics.

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The result is a step-change improvement in sterility assurance, faster contamination detection, and a recurring operating cost reduction measured in millions per site.

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Problem Statement

Current sterile monitoring practices introduce avoidable risk:

• Dedicated personnel enter Grade A/B areas solely to monitor sterility

• Manual handling of petri dishes is prone to labeling, timing, and exposure errors

• Results are delayed 24–72 hours, limiting proactive response

• Monitoring personnel themselves represent a contamination vector

• Labor cost is high while value creation is minimal

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This approach is fundamentally misaligned with modern automation and continuous improvement expectations.

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Solution Summary

The Sterile Monitoring Kiosk system removes humans from routine sterile monitoring and replaces them with a standardized, automated platform consisting of:

• Fixed Sterile Monitoring Kiosks

• Small robotic sampling vehicles (dog-class or low-profile AGVs)

• Automated petri dish or roll-media handling

• Near-real-time biological and particulate detection

• Integrated analytics, alerting, and audit trails

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System Architecture

Sterile Monitoring Kiosk

• Cleanroom-rated enclosed unit (stainless steel / polymer)

• Internal capacity for 40–100+ petri dishes or continuous roll media

• Automated indexing, exposure, sealing, and scanning

• HEPA-filtered intake and exhaust

• Touchless operator interface and visual confirmation

• Integrated optical, fluorescence, and molecular sensor bays

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Personnel Sampling Interface

• Controlled sampling alcove in front of kiosk

• Directed air puff and suction flow around:

  • Head and hood

  • Chest and torso

  • Arms and sleeves

  • Back and shoulder area

• Captured particulates deposited onto:

  • Agar plates, or

  • Continuous sterile roll media

• Eliminates subjective operator technique

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Robotic Sampling Vehicles

• Approximately 1/4 the footprint of a human operator

• Telescoping antenna arm holding petri dish at sampling height

• Autonomous navigation through sterile corridors

• Deploys, retrieves, and replaces environmental samples

• Docks with kiosk for unloading, scanning, and reload

• Removes humans from routine environmental rounds

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Contamination Detection Strategy

Available Today

• Accelerated optical CFU detection

• ATP bioluminescence screening

• Fluorescence-based particle discrimination

• Automated CFU counting and trending

Near-Term (12–36 Months)

• qPCR-based microbial identification

• DNA/RNA signature detection

• Virus-scale particle discrimination

• AI-driven anomaly detection by location, time, and operator

• Early-warning signals prior to visible colony growth

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The platform is sensor-agnostic, allowing future upgrades without redesign.

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Operational Workflow

1. Operator steps in front of kiosk sampling interface

2. Automated air puff and suction collect samples

3. Media is indexed, sealed, scanned, and logged

4. Robotic units perform environmental sampling on schedule

5. Results are analyzed locally and transmitted to MES/QMS

6. Dashboard displays:

   • 3 Passed

   • 1 Failed (contamination detected)

7. Alerts generated instantly for excursions

8. Full audit trail automatically preserved

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Regulatory Alignment

The system directly supports expectations from U.S. Food and Drug Administration and global regulators for:

• Reduced human intervention in aseptic areas

• Increased automation and consistency

• Faster deviation detection

• Stronger data integrity and traceability

• Continuous improvement in sterility assurance

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Business Model

Target Customers

• Sterile fill-finish pharmaceutical manufacturers

• Biologics and vaccine producers

• Cell and gene therapy facilities

• CDMOs with multi-line aseptic operations

Revenue Streams

• Capital sale of kiosks

• Robotic sampling vehicle add-ons

• Annual software, analytics, and validation subscription

• Consumables (media, roll cartridges, sensors)

• Sensor and capability upgrades

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Financial Model (Representative Site)

Baseline

• 30 dedicated sterile monitoring personnel

• Fully loaded cost: ~$60,000 per employee

• Annual monitoring labor cost: ~$1.8M

Post-Implementation

• 80–90% reduction in monitoring personnel

• Net labor savings: ~$1.4–1.6M per year

• Additional savings from:

  • Reduced gowning

  • Reduced training

  • Fewer deviations and investigations

Capital Investment

• 4–6 kiosks per site

• Estimated cost per kiosk: $350k–$500k

• Robotic sampling units: $75k–$150k each

Payback Period

• 18–30 months typical

• Faster for multi-line or multi-shift operations

Enterprise Scaling Example

• Single site: ~$3.6M annual cost reduction

• Five sites: ~$18M annual company-wide savings

• Standardized data across global network

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Why This Is Superior

• Removes contamination sources instead of managing them

• Eliminates subjective technique variability

• Converts sterility monitoring into a data-driven system

• Enables proactive rather than reactive response

• Scales without adding headcount

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Sterile Monitoring Kiosks redefine environmental monitoring from a regulatory obligation into an operational advantage. The platform delivers immediate cost reduction, measurable risk reduction, and a future-ready architecture for real-time sterility intelligence across the enterprise.

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This is not incremental automation. It is a structural improvement in how sterile manufacturing is monitored, protected, and scaled.

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