使用快速微生物方法 (RMMs) 将更安全、更清洁的产品推向市场

Celsis® 快速微生物检测仪可在 18-24 小时内提供质量控制结果,使您的质控微生物学团队能够确认产品质量并快速推向市场。Celsis® 仪使用 ATP 生物发光技术,这是一种经过时间考验的可靠检测方法,为以下问题提供自动化、客观的答案,最重要的是,提供的答案确凿无疑:“我的产品是否干净?”

作为 RMM 的领先产品,Celsis® 快速微生物检测技术可帮助您创建更简化、响应更迅速且更精益的制造流程,从而提高整个供应链的效率并降低质量成本。Celsis® 快速微生物检测平台有多种尺寸可供选择,满足各种业务和行业需求,并将改变您的经营方式。

用于快速微生物检测的 Celsis Advance II 仪

Celsis Advance II™ 系统旨在快速提供明确的结果。每小时能够运行 120 次测定,高通量制造商可以缩短生产周期,减少营运资金需求。


用于快速微生物检测的 Celsis Accel 系统

Celsis Accel® 系统吸取了广泛使用的 Celsis Advance II™ 平台的稳定和易用优势,但占用面积更小。该系统每小时可处理 30 次测定,专为中小型制药、家居和美容产品制造商而设计。

正在考虑为您的实验室采用快速微生物方法 (RMM)?

质控分析人员计数传统培养板方法使用的检测板许多实验室在确定合适的 RMM 以及如何开始选择过程时遇到了困难。幸运的是,我们整合了资源来帮助您做出决定。

获取 RMM 资源

Frequently Asked Questions (FAQs) about Rapid Microbial Detection Methods

  • What can I use an RMM to test?

    Rapid microbial methods are an ideal solution wherever there is a benefit in obtaining a faster time-to-result than the traditional method. However, the potential applications for rapid microbiology are much wider and more ubiquitous than this. Most traditional methods, involving enumeration or visual confirmation of contamination can be replaced with a rapid detection method. These include purified water, water for injection (WFI), microbial limits, bioburden counts typically expected to be 0 CFU, critical in-process steps, and for incoming raw materials.

  • Rapid microbiological methods are so expensive, how could I afford them?

    Rapid methods are expensive relative to the traditional method, when viewed solely through the lens of a cost-per-test comparison. With this in mind, it’s correct to consider them more expensive in the short-term, but incorrect to consider them more expensive in the long-term. Many labs fail to include the operational and day-to-day advantages that a faster time-to-result provides, such as reducing investigation times, confirming contamination response actions were effective, and resuming production faster. These improvements all make an RMM deliver cost savings that outweigh its initial capital expense.

  • What if I don't need a faster time to result? What other benefits can rapid microbiological methods provide me?

    The benefits of rapid microbial detection extend beyond just a faster time to result for quality control testing. While a faster result is the major positive impact of Celsis® rapid detection that users obtain, users also gain the ability to address and meet data integrity expectations and requirements from governance agencies. With its fundamental technology, using ATP-bioluminescence detection, along with its luminometer and software, Celsis® replaces the subjectivity of traditional enumeration or visual confirmation with an automated, reagent-based assay, controlled by an instrument. Results are controlled and reported through the software, avoiding transcription and interpretation errors potentially caused by an analyst recording and reporting handwritten results. Instrument usage and history can also be viewed using the system log, which can help meet audit trail requirements.

  • Do rapid microbial methods need to be validated before I can use them? How do I validate them?

    Yes, implementing a rapid microbial method is an alternative method to your traditional, compendial method, which was validated prior to use as well. Historically, this task was considered very difficult and a barrier to entry for QC microbiology labs not familiar with alternative rapid methods. However, regulatory agencies and industry consortiums have responded and have published additional guidance documentation to assist implementation. Additionally, technology suppliers have been encouraged to do so as well. Charles River can provide guidance on how to implement Celsis®, as well as additional services and support when feasible.

    Additional industry guidance documents can be found using the following links:

  • What should I do if I get a positive result?

    It is recommended that any detected microbial organisms be identified to the species level. The most reliable and accurate microbial identification method is DNA sequencing, which is the basis of our AccuGENX-ID® service. Another technology for identifying routine microbial samples is MALDI-TOF, which we offer as AccuPRO-ID®, or as Axcess® , our in-house solution. Charles River’s proprietary, validated microbial databases are the key to the most accurate identification results.