Annex 1 Compliance: Continuous Air Monitoring for Viable Particulates

With the 2023 revisions to EU GMP Annex 1: Manufacture of Sterile Medicinal Products, there has been increased emphasis on continuous viable air monitoring as part of cleanroom environmental monitoring programs. TRIO.BAS™ offers advanced viable air-sampling solutions engineered to support compliance with these revised standards. Ahead, we’ll see how these instruments perform and reinforce Annex 1’s core expectations.

Regulatory Pillar: Annex 1’s Call for Continuous Monitoring

The updated EU GMP Annex 1 (sections 9.22 and 9.24) emphasizes:

• Frequent microbial monitoring - Where aseptic operations are performed, microbial monitoring should be frequent using a combination of methods such as settle plates, volumetric air sampling, glove, gown and surface sampling (e.g. swabs and contact plates).¹
• Continuous viable monitoring  - Continuous viable air monitoring in grade A (e.g. air sampling or settle plates) should be undertaken for the full duration of critical processing, including equipment (aseptic set-up) assembly and critical processing.¹
• A similar approach should be considered for grade B cleanrooms based on the risk of impact on the aseptic processing.

TRIO.BAS™: Continuous Monitoring, Simplified

TRIO.BAS™ offers a suite of continuous air microbial monitoring systems built to satisfy Annex 1 mandates:
Multi-Head Sampling for Less Intervention
Models like AIRBIO DUO, TRIO, and RABS ISOLATOR CM feature multiple aspirating heads or satellites to:

1. Divide a work shift into discrete monitoring segments, which helps identify potential contamination timings.
2. Can reduce human interventions to just the start and end of shifts.
3. Support sampling across multiple critical locations with minimal disturbance.

Low Flow Rate to Protect Sampling Media

Continuous air sampling risks dehydrating agar media, which can compromise microbial recovery. TRIO.BAS™ units mitigate this by operating at a lower flow rate of 25 liters/minute, helping to preserve media integrity throughout monitoring.

Flexible Monitoring via Satellites

The RABS ISOLATOR CM system supports attachment of up to three satellite units, providing flexible placement across risk-prone zones while centralizing control.²

TRIO.BAS™ systems come with:

• Bluetooth connectivity for seamless data transfer and integration
• IQ/OQ/PQ validation documents
• Optional “Daily Shift” gamma-irradiated aspirating heads for sterility assurance and simplified changeovers
• Standard Petri or contact plate models available

Why TRIO.BAS™ Aligns with Annex 1 Requirements

Final Thoughts

TRIO.BAS™ supports continuous viable air monitoring, reduces operator intervention, and enhances detection in critical environments. With flexible options such as multi-head models, support for standard Petri or contact plates, and features designed to protect sampling media during extended monitoring, TRIO.BAS™ CM instruments provide modern cleanroom compliance aligned with EU GMP Annex 1.

Sources:

_{1. European Commission. (2022, August 25). EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use: Annex 1 — Manufacture of sterile medicinal products. https://www.gmp-compliance.org/files/guidemgr/20220825_gmp-an1_en_0.pdf}

_{2. TRIO.BAS. (n.d.). RABS ISOLATOR CM system: Continuous air microbial monitoring [Product information]. TRIO.BAS. https://www.triobas.com/products/continuous-air-microbial-monitoring}

_{3. Brackeen, Joelle. “Are You Annex 1 Ready? Continuous Air Monitoring for Viable Particulates.” Hardydiagnostics.com, Hardy Diagnostics, 28 Jan. 2026, hardydiagnostics.com/blog/annex-1-compliance-continuous-air-monitoring-for-viable-particulates}