Sampling for viable contamination is critical when manufacturing in aseptic environments, also known as Grade A areas. The AeroTrak®+ Remote Active Air Sampler is part of TSI’s complete environmental monitoring solution and was specifically designed for use in these environments.

Pharmaceutical products that cannot be terminally sterilised must be processed in aseptic environments to prevent contamination that could put patients at risk. It is important that viable air samplers used in these environments not pose a contamination risk, be easy to operate, and ensure a high level of detection. With this in mind, it is important to understand how the TSI AeroTrak+ Remote Active Air Sampler was designed to be fit for use in these critical environments.

As air passes through an active air sampler, it can pick up particles of media and other contaminants. To prevent these particles from being released into the aseptic environment, the TSI AeroTrak+ Remote Active Air Sampler pulls the exhaust out of the aseptic area.

Some samplers have electronics in the sample head, which renders them unable to be autoclaved and difficult to fully sanitise with VHP. All components of the TSI AeroTrak+ Remote Active Air Sampler that are installed inside the isolator or RABS are made of stainless steel. As such, theyand are fully autoclavable and VHP-compatible.

Unidirectional airflow is often a critical component of controlling contamination in aseptic environments. The TSI AeroTrak+ Remote Active Air Sampler has a low flow rate that avoids disturbances to the airflow. This also permits sampling over longer periods of time, providing the opportunity to perform active sampling during more of the aseptic process without the contamination risk of a manual intervention. Intermittent sampling capabilities can provide even greater intervention-free coverage of the aseptic operation.

Some active air samplers have poor collection efficiency, potentially leading to undetected contamination. The TSI AeroTrak+ Remote Active Air Sampler has proven efficiency that exceeds the stated regulatory expectations for physical efficiency.

Poorly designed active air samplers make loading and unloading plates difficult. This prolongs interventions, increasing the risk of contamination, and may result in a deviation from a misaligned plate or cap. In contrast, the TSI AeroTrak+ Remote Active Air Sampler makes handling easy with a large sidewall and finger grooves. It also provides visual and tactile indicators to ensure proper installation from alignment notches and engagement pins.

The TSI AeroTrak+ Remote Active Air Sampler is part of the complete TSI Environmental Monitoring System designed for use in aseptic pharmaceutical manufacturing environments to deliver confident, reliable microbial monitoring.