SAS Super ISO 100 & SAS Super ISO 180: Portable Microbial Air Samplers with Expanded Data-Integrity Controls
 SAS Super ISO portable microbial air sampler |
The SAS Super ISO 100 and SAS Super ISO 180 microbial air samplers combine the proven collection performance and operational flexibility of the SAS platform with expanded user-management, audit-trail, access-control, and secured data-export features. The SAS Super ISO is especially well suited for pharmaceutical, biotechnology, hospital, medical-device, and other organizations that want additional data-integrity controls built directly into the sampler, for streamlined 21 CFR Part 11 compliance out of the box. As with any product used within a broader operational system: complete end-to-end compliance also depends on the customer's validated process, SOPs, access controls, training, system configuration, and record-management practices. The SAS Super ISO uses standard 55-65 mm contact plates or 90-100 mm Petri dishes, depending on the selected sampling head, and it is available in 100 or 180 L/min configurations. |
Key Benefits of the SAS Super ISO 100 & SAS Super ISO 180 Microbial Air Samplers
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Built-in support for 21 CFR Part 11-controlled workflows - User Management mode provides individual credentials, role-based access, an electronic audit trail, protected sampling records, and controlled export functions. These features can reduce the amount of procedural infrastructure that must be created around the sampler during initial implementation. |
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Role-based user management - supports up to 100 users assigned as Operator, Supervisor, or Administrator, with different access rights for sampling, configuration, user administration, record handling, and system settings. |
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Electronic audit trail - records time-tagged administrative actions involving user credentials and sampling-record management, including user creation, enabling, disabling, reassignment, password reset, and record deletion. |
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Expanded internal record capacity - automatically stores up to 1,200 completed sampling runs in internal flash memory. Stored sampling records cannot be altered by an operator, and the instrument warns users if record or audit-trail memory nears capacity. |
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Secured PDF and LIMS-friendly XML export - sampling records can be exported in password-protected PDF format or LIMS-friendly XML format for controlled archiving, review, and integration with laboratory information-management workflows. |
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Controlled USB access - data can be transferred by USB flash drive or by direct USB-C cable connection to a PC. In 21 CFR Part 11 User Management mode, USB configuration is administrator controlled. Selecting PC cable mode causes the sampler to stop recognizing USB flash drives, allowing a site to restrict removable-media export, if required by corporate IT policy. |
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SAS Archiver PC software - supports direct download of sampling logs and audit trails, storage of device configurations, and transfer of validated settings to additional SAS ISO instruments. This can simplify standardization across departments, facilities, or multiple instruments. |
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Low running cost and media flexibility - no need to purchase expensive proprietary media strips, cassettes, or plates. The SAS ISO supports standard 55-65 mm contact plates or 90-100 mm Petri dishes, depending on the selected head configuration. |
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Third-party validated collection performance - SAS 100 L/min and 180 L/min configurations have independently measured physical and biological collection efficiency, including d50 values below 2 microns that support the applicable collection-performance requirements of EN 17141 and ISO 14698. |
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Designed for cleanroom operation - the SAS family has been tested for limited disturbance of unidirectional airflow, avoidance of re-aspiration of exhausted air, and absence of particle emission during environmental-contamination testing. |
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NIST-traceable, ISO/IEC 17025:2017 accredited calibration certificate with each unit - Bioscience International calibrates the sampler to verify actual airflow and provide traceability tied to international standards. IQ/OQ services and other validation documentation are also available upon request. |
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Autoclavable and disposable head options - reusable stainless-steel heads can be autoclaved, and sterile single-use daily heads are available for programs that prefer to reduce handling and autoclave requirements. |
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Programmable sampling workflows - supports selectable sample volumes, delayed start, programmable multi-cycle interval sampling for continuous monitoring, site identification, and optional infrared remote control for flexible unattended monitoring. |
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Portable, rechargeable operation - battery capacity supports approximately 70,000 liters of sampling in the 100 L/min configuration or 40,000 liters in the 180 L/min configuration, helping the instrument remain available through demanding monitoring schedules. |
What the SAS Super ISO Records - and What It Does Not
The SAS Super ISO records the circumstances of the air-sampling activity: run ID, date, time, user ID, site or room, sampled air volume, and whether the run was completed or interrupted. This information provides traceability metadata showing who performed sampling, where it occurred, when it occurred, and how much air was collected.
The actual microbiological test result data is generated outside the instrument. After sampling the agar plate is removed, incubated, and evaluated to determine whether microorganisms grew and, when required, which organisms were identified. The SAS Super ISO therefore stores sampling-activity metadata; it does not itself determine or store the final microbial-growth data.
This distinction is important when evaluating 21 CFR Part 11 requirements. The SAS Super ISO's built-in controls strengthen the integrity and traceability of electronic sampling records, while the laboratory's SOPs and validated systems address activities that happen after the air sampling is completed: incubation, colony counting, organism identification, review, approval, and retention of the complete microbiological result.
Frequently Asked Questions
How does the SAS Super ISO help make an environmental monitoring process 21 CFR Part 11 compliant?
The SAS Super ISO provides a strong set of built-in controls that support a compliant workflow. As with any product used in an operational system: end-to-end compliance depends on the complete validated process – including SOPs, user administration, training, configuration control, review, retention, backup, and management of the offline microbiological results.
Should I select the SAS Super ISO 100 or SAS Super ISO 180?
Both configurations use the same equipment platform and are currently priced the same, so the choice should be based on the end user's desired sampling method and workflow rather than price.
Bioscience International generally recommends the faster 180 L/min flow to reduce operator labor time, especially for: 1,000 L or larger samples, frequent sampling, or work across multiple rooms or locations. A 1,000 L sample takes approximately 5.5 minutes at 180 L/min, versus approximately 10 minutes at 100 L/min.
The 100 L/min configuration is best when an existing SOP or validated historical method requires 100 L/min, or when interval-based continuous monitoring is being performed and slower airflow can help media remain usable for longer before drying.
Can a customer prevent operators from exporting records to a USB flash drive?
Yes. An administrator can configure the SAS Super ISO for USB cable mode. In that configuration, the instrument does not recognize USB flash drives, while controlled PC-based transfer remains available through SAS Archiver.
Can the SAS Super ISO use the same standard media formats as other SAS samplers?
Yes. The sampler is available for standard 55-65 mm contact plates or 90-100 mm Petri dishes, and reusable or sterile disposable head options are available. All ISO 17025 accredited calibrations performed by Bioscience International are done with the end user's exact media type (when provided), ensuring consistency between calibration and actual operational use.
For pricing, model-selection assistance, and more information about the SAS Super ISO 100 and SAS Super ISO 180 microbial air samplers, please contact Bioscience International by filling out the form below or calling (301) 231-7400.