适用于质控 微观 检测的快速微生物污染筛检
20 年来，Celsis® 系统一直帮助全球公司进行针对微生物污染的产品筛检。Celsis® 已在超过 65 个国家/地区得到应用，加上全球服务和支持合作伙伴网络，使其拥有突出优势，非常适合用于各种规模的公司，帮助其减少延迟以及与漫长的微观保持时间相关的成本。
Celsis Advance II™ 系统提供更多功能和更易用的特性，包括：
该系统用于运行与当前 Advance 系统相同的协议，并能生成相同的结果。对于从旧 Advance 平台升级的站点，无需产品重新验证。我们已开发出安装资格和操作认证协议来无缝管理系统传输。
Celsis Advance II™ System Features
- Runs up to 120 samples per hour with the option of combining multiple batches or protocols into a single run
- Offline incubation maximizes system throughput
- Click to start: enjoy walk-away automation
- Recommended for quality control microbiology laboratories supporting large scale pharmaceutical and personal care manufacturing
- Recommended for rapid sterility applications when multiple samples are tested
Advance.im™ Software Features
- A new, secure ‘Remote User Option’ allows monitoring of product quality testing results from multiple locations, facilitating global data integrity harmonization initiatives.
- Automated data capture and storage, exporting to common database programs, including Excel and Access.
- Design and generate graphs for easy data trending and report generation.
- Customizable security levels with one-click lockout.
- Fully validated on Microsoft Windows® operating systems.
- Allows full compliance with the FDA’s 21 CFR Part 11 and the European Union’s Annex 11 recommendations for data integrity best practices.
- Small-scale footprint:
- 28.5” x 15.8” x 17” (w x h x d)
- 65.6 cm x 40.1 cm x 43.3 cm (w x h x d)
- Weight: 62 lbs/ 28 kg
- Electrical Requirements: 100 – 240 Volts, 50 or 60 Hz
- Optional Fourth Injector
Product Code Celsis Advance II™ System 7456004
- Small-scale footprint:
How the Celsis Advance II™ System Works
The Celsis Advance II™ system runs the selected protocol measuring the light output of the ATP bioluminescence reaction, and then presents the results in a color-coded table or graphical view. Up to four variable-volume reagent injectors ensure accuracy, reduce sample handling and increase flexibility. System throughput runs as high as 120 tests per hour with the option of combining multiple batches or protocols into a single run.
Frequently Asked Questions (FAQs) About Data Integrity & Rapid Microbiology
What is data integrity in microbiology quality control?
Data integrity is a collection of practices that lead to secure reporting, handling, and archiving of quality control testing data generated in the microbiology lab. Data integrity allows laboratories to make sound decisions based on their test data and have confidence that the data is not inadvertently or intentionally manipulated.
How do instruments like the Celsis Advance II help with data integrity?
Instruments like the Celsis Advance II and Celsis Accel lead to better data integrity practices in two ways: by replacing subjective tests involving visual, human-based confirmation of no growth with an automated assay, and by handling the reporting of results via software.
What’s the risk of using subjective test methods with data integrity?
With subjective tests such as visual turbidity or visual enumeration of plates that are typically 0 CFU (such as Water for Injection), there is a risk of missing a positive count. In certain production processes, contaminations are so infrequent that analysts do not have experience ever seeing a certain sample come back positive, or maybe become accustomed to samples never being contaminated. Additionally, when transcribing and reporting results, analysts can make transcription errors due to handwriting or mistaken keystrokes.