The new EU GMP Annex 1 revision will come into effect on 25 August 2023, exactly one year after being published. The new revision emphasises the importance of continuous monitoring during critical processing, including aseptic equipment assembly and filling operations.
Environmental monitoring – non-viable particles
- “For the Grade A zone, particulate monitoring should be undertaken for the full duration of critical processing, including equipment assembly.”
- “Routine monitoring of cleanrooms, clean air equipment and personnel should be performed in operation throughout all critical stages, including equipment set-up.”
Environmental monitoring – viable particles
- “Continuous viable air monitoring in the Grade A zone (e.g. air sampling or settle plates) should be undertaken for the full duration of critical processing, including equipment (aseptic set-up) assembly and filling operations. A similar approach should be considered for Grade B cleanrooms based on the risk of impact on the aseptic processing.”
EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022).
Continuous monitoring, based on quality risk assessments, ensures that viable and total particle contamination is not present in your critical areas throughout the manufacturing process, which increases confidence in product sterility.
Traditionally, active air samplers and particle counters have sampled air for a short period of time, providing a quick snapshot of the air quality during that time. Operators often use active air samplers in this way to take many samples from different locations around the facility.
However, to properly ‘monitor’ air quality, rather than just sample it, manufacturers need to ensure the air is sampled for extended periods of time, especially during critical operations.
To meet the new requirements of Annex 1, MSC are delighted to introduce the BioTrak Real Time Microbial Monitoring System and AeroTrak A100 Portable Particle Counter.
AeroTrak-Plus Portable Particle Counter A100 Series
AeroTrak+ A100 Portable Airborne Particle Counters are ideal for cleanroom certification, monitoring, and specialised tasks such as filter scanning and gas testing.
- Configured for Annex 1 compliance
- Sampling duration: 1 second – 24 hours, or continuous
- 100L/min flow rate, 0.5 – 10 μm
- Traffic light status display – LED light bar visible from 20 meters
- Multi-level user access with audit trail
- Lightweight build – 5.8kg
- Industry-leading 5-year laser warranty
- Fully cleanable, 316 stainless steel housing
- Report generation with TrakPro™ Lite Secure Software (free of charge)
- 250k data records storage capacity
- 4-20 mA analogue particle data output
- Dry contacts for alarm output
- 2 x USB-A ports, 1 x USB-C port, 1 x Ethernet port, WiFi
BioTrak – Real Time Microbial Monitoring
Provides total and viable particle counts in real-time, reducing aseptic interventions, improving root-cause investigations, and increasing process knowledge.
Features & Benefits
- Combines viable particle counting—also called biofluorescent particle counting (BFPC)—with ISO-compliant total particle counting to offer a complete solution for pharmaceutical environmental monitoring.
- Superior discrimination between viable and inert particles delivers reliable viable particle data.
- Gelatine filter technology efficiently captures sampled microorganisms for subsequent identification.
- Can be used in tandem with traditional settle plates to allow operators to react to air quality deviations in REAL TIME.
- Allows batch runs to be paused if air quality goes out of spec – no need to pull huge portions of a batch when a micro plate shows contamination up to 5 days later.
- Automated data collection with the 21 CFR Part 11-capable FMS Software assures the highest level of data integrity.
- 1 CFM (28.3 L/min) sample flow rate.
- Only requires a single isokinetic probe at the sample site.
- Cleanroom Certification
- Online Monitoring
- Trending of Biological Particulate levels
- Process Improvement
- Operator Training
- Qualification Tool
- Risk Management
- Root Cause Investigations
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