The MAS-100 Sirius® Air Sampler takes samples of the ambient air in high-grade cleanrooms in pharmaceutical manufacturing environments. Any contained microbial contaminants precipitate on a Petri dish filled with culture medium (e.g. 90 mm ICR/ICRplus Settle Plates), on which they grow into colonies upon subsequent incubation.
The MAS-100 Sirius® Air Sampler is built on decades of engineering expertise, microbiological experience, regulatory knowledge and interaction with customers. By combining proven performance, refined data handling and smart features, it makes viable air sampling in high-grade cleanrooms more convenient and reliable than ever before. The sampler was developed with compliance in mind, making it as easy as possible to fulfill the regulatory requirements for GMP-compliant environments and thus avoid issues at inspections.
The instrument is equipped with many smart features and properties to minimize the risk of human errors and ensure reliable results. Its robust and easy-to-clean housing is compatible with a broad range of sanitizers. Inner parts can be decontaminated, for example in a VHP transfer chamber, even while the blower operates. The HEPA exhaust filter avoids cross-contamination when transferring the instrument from a lower to a higher grade cleanroom. An integrated dual mass flow sensor regulates the air flow rate to ensure consistency and accuracy, while leak tests ascertain that the perforated lid is tightly closed. In combination, they give an early warning in case of possible out-of-specification flow rates. Furthermore, there are smart self-checks that warn the operator if, for example, the HEPA filter or the right lid type is not in place.
The MAS-100 Sirius® air sampler is readily equipped for a digital QC lab. It offers various connectivity options and a result barcode feature for secure and seamless data transfer into a LIMS or EM software. An optional Wi-Fi dongle allows the sampler to be integrated into internal Wi-Fi environments.
The MAS-100 Sirius® air sampler offers unrivalled convenience and ease-of-use, reliability, error prevention and regulatory compliance thanks to the following features:
Convenience and ease of use:
- Choice of 100 and 200 L/min air flow rate, with the latter reducing sampling time by 50% at comparable efficiency
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Magnetic lid closure to close and open the perforated lid via handle
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Customizable, user-friendly touchscreen to adapt the settings to the workflow – can be operated with gloves on
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Easy to clean and disinfect, compatible with a broad range of sanitizers – even inner parts can be decontaminated
Reliability and error prevention:
- Robust, stainless steel housing, stable footing
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Dual flow sensor and leak tests to prevent out-of-specification flow rates going unnoticed between scheduled calibrations
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Instrument self-checks and smart features to reduce handling errors
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HEPA exhaust filter to avoid cross-contamination when transferring the instrument from a lower to a higher grade cleanroom
Regulatory compliance:
- Browser-managed, 21 CFR Part 11 compliant software that supports data integrity, data tracking, individual user roles and logins
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Sampling efficiency independently validated avoiding issues at inspections
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Accurate flow rates, anemometer calibrated in an ISO 17025 accredited lab
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Automated timer calibration thanks to Network Time Protocol (NTP) server connection