Expert focus: EU GMP Annex 1

Environmental monitoring with MAS-100 ISO

Manufacturers must ensure a systematic and routine assessment of their manufacturing environment by monitoring air quality, surface contamination, and other relevant parameters within cleanrooms and critical zones. Chapter 9 gives guidance on such routine monitoring,  including alert and action levels, as well as data handling. The following are key requirements and they can already be met with MAS-100 Iso viable air samplers:

• Identification to species level (§9.31): The MAS-100 Iso takes a representativ sample at an isokinetic flow rate of 100 litres/minute at each critical control point, collected on an agar plate. Agar-based methods permit germ identification, which is imperative for root cause analysis and ongoing process improvement.
• Continuous viable air monitoring in grade A (§9.24) and combination of methods (§9.22): By combining active air sampling with MAS-100 Iso, and continuous monitoring with a traditional settle plate, both requirements are met.
• No growth in Grade A (§ 9.30): Active air sampling delivers a quantitative volumetric snapshot sample taken with an ideal combination of biological and physical sampling efficiency. It complements other monitoring methods to prevent unwanted product contamination. 
• Supporting data for recovery efficieny (§ 9.29): MBV customers benefit from consistent, high-quality equipment, accompanied by detailed documentation on performance, and physical and biological recovery efficiency. Traceability of data to international standards is assured by calibration tools calibrated in MBV’s own ISO 17025-accredited laboratory.
• Consider rapid methods (§ 9.28): MBV collaborated with Rapid Micro Biosystems to create a solution for active viable air that enables customers to use rapid methods with their Growth Direct® plates.

The importance of isokinetic sampling

The subject of isokinetic sampling of particles is – although vital in connection with the usually relatively large viable particles – barely mentioned in Annex 1. However, the representative collection of particles from the air over a defined time and area, without disturbing the air path, must be the objective. MAS-100 Iso is designed to sample air at a flow rate of 100 litres per minute. This is achieved isokinetically – ie, within the surrounding air flow and without any histogram shift of the sampled particles that may over- or under-sample microbe-carrying particles. 

Embrace Annex 1 with confidence 

We at MBV already offer solutions so that our customers can embrace Annex 1 with confidence. Not only do the MAS-100 Iso products themselves comply with the regulations, but in combination with a settle plate, they also enable compliant continuous air monitoring during operation and airborne germ analysis in aseptic production. MBV controls the entire value chain from design and manufacturing, through to distribution and after-sales service. It works directly with quality containment producers, so we can support clients in customising their equipment, and have already automated active microbial air sampling for several of its customers.