The days when it was feasible to perform the documentation of microbial QC tests on paper or with the help of Excel sheets are rapidly coming to an end. Such manual procedures tend to be error-prone and make it difficult to keep up with the growing regulatory demands to further improve the safety of pharmaceutical products and thus patient health. However, digitalization of data management is enabling significant improvements in data integrity and traceability and a reduction in the likelihood of handling errors. Manufacturers of QC equipment have begun designing instruments that can be integrated into a fully digital data environment. One example is the recently launched MAS-100 Sirius® air sampler, which was designed to support digitalization and make active microbial air monitoring in high-grade cleanrooms more reliable and convenient.
Ensuring compliance now and in the digital future of QC
To be suitable for the digital future, QC instruments for use in GMP-compliant environments should facilitate both data integrity and traceability. Data integrity minimizes the risk of data handling errors and improves decision-making, while traceability makes it easier to pass audits successfully. To ensure compliance, all relevant data and metadata of a QC test must be captured, linked to the correct batch datasets, stored safely and remain retrievable over the entire life cycle of the cGMP data. What to capture should routinely include instrument parameters, consumables data, user ID, time, location, comments on test execution and, of course, each test’s results. Scannable barcodes on consumables or on the display of the instrument facilitate digital data management.
The MAS-100 Sirius® microbial air sampler for high-grade cleanrooms allows all the above requirements to be met, thanks to its data management features:
- 21 CFR Part 11 compliant software that supports data integrity, data tracking, individual user roles and logins, time-stamped audit trails
- Browser-based software control requiring neither an internet connection nor installation
- A unique result barcode for wireless data transfer into a LIMS or environmental monitoring software
- Remote managing options with optional Wi-Fi adapter
Reducing the likelihood of handling errors
Handling errors can occur not only with respect to data but also while a test is being performed. This can lead to false positives or false negatives and thus compromise the reliability of the test result. In such an event, time-consuming and costly out-of-specification investigations become necessary, so it is important that an instrument’s design minimizes the potential for human error.
The MAS-100 Sirius® air sampler offers features that improve ease of use and thus reduce the likelihood of human errors:
- Magnetic perforated lid for easy closure and opening
- Customizable touchscreen to adapt settings to the workflow, operable even with gloves on
- Choice of 100 or 200 liters per minute air flow, with the latter reducing sampling time by 50% at comparable collection efficiency
- Both air flow rates calibrated in an ISO 17025 accredited lab
- Dual flow sensor and leak tests to prevent out-of-specification flow rates going unnoticed between scheduled calibrations
- Instrument self-checks and smart features to reduce handling errors
- Stainless steel housing with minimized dirt traps for easy cleaning and disinfection
- Housing compatible with a broad range of sanitizers
Setting standards in active air sampling
Most pharmaceutical manufacturers are currently in a gradual process of digitalizing their QC. Upgrading a facility in one big digitalization effort is usually too disruptive, so most are taking a controlled step-by-step approach, implementing individual digital QC solutions one by one. This is why it is important to take both current and future needs into account when deciding on new microbial QC instrumentation. With its advanced digital data management capabilities and features to minimize human errors, the MAS-100 Sirius® active air sampler is setting standards for data integrity, traceability, reliability and convenience in viable air sampling.
Get to know more about the new MAS-100 Sirius® air sampler
