WEBINAR LWS: Risk-Based Airborne Probe Placement for Sterile Manufacturing

Webinar Overview

Building a Science-Based, Risk-Driven Environmental Monitoring (EM) Program

For many years, legacy Environmental Monitoring (EM) programs have placed fixed probes in “convenient” locations without clear scientific rationale or documented risk assessment. This approach is no longer acceptable to regulators.

This webinar introduces a practical, repeatable framework for determining where isokinetic airborne particle probes should be placed so that collected data truly reflect actual contamination risk to the aseptic process, rather than background noise or original design intent.

Participants will learn a nine-step workflow aligned with EU GMP Annex 1:2022 and ISO 14644-1:2015, supported by:

• Real-world examples
• A ready-to-use checklist
• Practical probe placement principles combining process knowledge, airflow science, and risk assessment

Who Should Attend

• QA / QC managers in sterile manufacturing
• Environmental Monitoring (EM) specialists and technicians
• HVAC and Facility Engineering teams supporting aseptic operations
• Production managers and batch record owners
• Regulatory Affairs and Compliance professionals
• GMP consultants supporting audits and FDA Form 483 responses
• Sterile manufacturing facility directors and operations leaders

Why You Should Attend

1. Regulatory Pressure Is Increasing

Recent FDA Form 483 observations, internal audits, and EU GMP inspections increasingly challenge EM programs that lack documented justification for probe placement.

Annex 1:2022 explicitly requires that:

“Monitoring locations should be appropriate to obtain reliable data from critical zones.”

Placing probes simply “to comply” is no longer sufficient.

2. Data Quality Is Critical

Incorrectly positioned probes often result in:

• Sudden particle spikes
• False alarms
• Unreliable or misleading trends

➡ These issues drive unnecessary investigations and consume significant QA/QC resources.

3. A Science- and Risk-Based Approach

This framework integrates:

• EU GMP Annex 1
• ISO 14644-1
• ICH Q9 – Quality Risk Management
• Smoke studies (airflow visualization)

➡ Proven to work across filling lines, compounding areas, RABS, and isolator systems.

Core Methodology – The 9-Step Workflow

Step 1: Define Scope and Critical Operating Areas

Clarify the process, identify product exposure points, and recognize high-risk influences such as doors, airlocks, and operator interventions.

Step 2: Collect Design and Historical EM Data

Review:

• HVAC and HEPA layout drawings
• Cleanroom classification results
• Deviations, OOS events, and alarms
• Existing probe and sensor maps

➡ Understand how the cleanroom actually performs, not just how it was designed.

Step 3: Conduct a Cross-Functional Walkthrough

Perform an on-site walkthrough with Production, QA, Engineering, and EM, mapping:

• Personnel flow
• Product flow
• Material and waste movement

➡ Identify real behaviors versus written SOPs.

Step 4: Perform Smoke Studies Under Dynamic Conditions

Visualize airflow to identify:

• First-air paths
• Bounce-back and recirculation zones
• Operator impact
• Door-driven air ingress

Step 5: Apply Probe Placement Principles

• Within approximately 30 cm of critical zones
• Aligned with local airflow direction
• At working height
• Away from short-circuits and dead zones

Step 6: Perform Risk Scoring for Each Location

Evaluate:

• Likelihood
• Impact
• Detection capability

➡ Determine where fixed probes are mandatory versus where portable monitoring is sufficient.

Step 7: Standardize Practical Placement Rules

Define clear tactics for probes near:

• Operators
• Doors and airlocks
• HEPA returns
• Product and material transfer paths

Step 8: Create Maps and Documentation

Develop facility drawings including:

• Unique probe IDs
• Placement justification
• Linkage to critical zones
• References to Annex 1 and ICH Q9

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Step 9: Verify and Periodically Review

• Confirm fixed probe data aligns with smoke studies and portable measurements
• Integrate probe locations into the Contamination Control Strategy (CCS)
• Trigger reviews after process or HVAC changes

Value You Will Gain from This Webinar

Participants will receive:

• ✅ A ready-to-use EM checklist
• ✅ Example probe placement maps
• ✅ A risk scoring template
• ✅ Practical decision-making rules.

👉 Register Now with Filterfine Vietnam

Join the webinar here:
https://www.golighthouse.com/en/webinars/risk-based-airborne-probe-placement-for-sterile-manufacturing-january-16-1am-pacific/?wspage=register