FAQs

Below are answers to questions commonly asked by individuals researching rapid detection and Celsis®. If your question is not answered here, please contact us.

Deciding on a rapid detection system

  1. What makes the Celsis® method better than traditional methods?
  2. How will I know if the Celsis® system will work with my product(s)?
  3. What should I look for in a system?
  4. Is ATP an accepted technology?
  5. Is the Celsis® rapid method easy to use?

Implementing a Celsis® system

  1. What's included in the Celsis® system?
  2. What materials are needed other than the instrument?
  3. What products can be tested with Celsis®?
  4. Is the system more sensitive than traditional testing? Will I get more “positive” results?

Financial benefits

  1. What is the typical return on investment (ROI) from implementing Celsis®?
  2. How can I predict my company’s return on investment?
  3. How does the cost per test compare to traditional testing?
  4. How do I purchase reagents? Which ones do I need?

Validation

  1. How do I validate the Celsis® system?
  2. Can I use Celsis® if my product is controlled or regulated?

The technology

  1. What are the results and how are they interpreted?
  2. Does your system give direct results on the number and type of organisms present?
  3. Does the system identify organisms?
  4. We need to quantify. Does your system provide enumeration?
  5. Can the Celsis® system be used to test samples without incubation or enrichment (i.e., real-time test)?
  6. Can the system detect stressed cells, spores and anaerobes?
  7. Do RLUs correlate with CFUs?


Answers

Deciding on a rapid detection system

  1. What makes the Celsis® method better than the traditional method? Celsis® is a growth-based method that is similar to the traditional method, but with significant business benefits. It is an equivalent yet faster method that reduces operating costs by reducing product hold times. It also improves lab efficiency and contributes to sustainability in the lab.
  2. How will I know if the Celsis® system will work with my product(s)?
 The Celsis® system is compatible with the broadest range of products of any rapid microbial method. If you are testing your products for microbial contamination today, Celsis® will work. The best way to find out is to contact us.
  3. What should I look for in a system? Some of the key features to look for are: the ability to test a wide variety of products, an easy-to-use procedure, a non-destructive test method, training and support where and when you need it, and a fast and accurate time to results.
  4. Is ATP an accepted technology? Yes. ATP bioluminescence is the proven, gold standard for product screening and rapid release. Only Celsis® offers AMPiScreen, an exclusive, amplified-ATP technology that delivers results in as few as 18–24 hours, up to 50% faster than standard ATP and 80% faster than traditional methods.
  5. Is the Celsis® rapid method easy to use? Yes. While some rapid methods require significant training and expertise, Celsis® systems are easy to use. We employ a very simple and straightforward process that is similar to traditional methods, but much faster.

Implementing a Celsis® system

  1. What's included in the Celsis® system?
 The Celsis® system is composed of four parts: the luminometer, software, proprietary reagents and global support. The latter includes installation and on-site training, technical support, customer service and, if needed, regulatory support services.
  2. What materials are needed other than the instrument?You will need a dedicated computer and monitor, plus standard lab equipment, including an incubator, shakers, gloves and pipettors. Reagents are purchased from Celsis®. You can choose to make or purchase broth.
  3. What products can be tested with Celsis®?
 Only Celsis® rapid detection systems can test filterable and non-filterable products; solids; opaque, turbid and highly pigmented products; and pulpy, viscous and other difficult-to-test materials. Celsis® can also be used for water testing and cleanroom monitoring.
  4. Is the system more sensitive than traditional testing? Will I get more “positive” results?
 Celsis® is equivalent to the compendial method. If your products are mostly free from bioburden today, they are excellent candidates for Celsis® technology.

Financial benefits

  1. What is the typical return on investment (ROI) from implementing Celsis®?
 Most companies implementing Celsis® for a single plant will recoup their investments in six to nine months and enjoy a five-year, net present value (NPV) of $500,000.
  2. Can I predict my company’s return on investment?
 The Celsis® Financial Impact Assessment will provide a highly accurate forecast of the financial benefits to your company. Based on your company-specific information, it calculates your return on invested capital and five-year net present value (NPV). Contact Celsis® for a complimentary assessment.
  3. How does the cost per test compare to traditional testing? 
When you consider the operational savings, Celsis® costs less per test than traditional methods and can save your company money. Also, consider the cost to your company of a recall. The benefits of a Celsis® system double during a contamination event.
  4. How do I purchase reagents? Which ones will I need? Reagents are determined by your product mix and are purchased directly from Celsis® or through your authorized distributor.

Validation

  1. How do I validate the Celsis® system?
 The Celsis® method is very similar to the traditional method; they are both growth based. Generally our customers perform (or have us perform) a spiking study and then proceed with parallel testing. Read more on our pharma page.
  2. Can I use Celsis if my product is controlled or regulated?
 Yes, Celsis® methods have been included in numerous supplemental, amended and original new drug applications. Our drug master files on record with the FDA will save you considerable submission paperwork. Celsis® also has regulatory compliance experience to help you navigate your regulatory and governing bodies worldwide.

The technology

  1. What are the results and how are they interpreted?
 The results are read in relative light units (RLUs), captured by the sensitive luminometer and color coded: Green means “go” so you can release your products. If there is failure due to possible contamination, it is highlighted in red. The clear absence/presence results mean no specialized training is required to interpret the assay.
  2. Does your system give direct results on the number and type of organisms present?
 Celsis® is an absence/presence test used to release the vast majority of your products quickly. If you currently test your products and many of them have little-to-no bioburden, then Celsis® is a good fit to “lean” your quality department and improve your company’s profitability. It delivers the results needed to release product to market quickly.
  3. Does your system identify organisms? 
If your products are typically within specification and you rarely get a count, then there is no reason to be doing all the extra work. You need to identify organisms only in product that routinely grows organisms. If your product does not, it is an excellent candidate for using Celsis® as a rapid primary assay for fast product release.
  4. We need to quantify. Does your system provide enumeration? 
If your products test negative 95–99% of the time, enumeration is only useful for 1–5% of your products. The rest of the time (95–99%) you are using up important resources to “count to zero.” Celsis® is a rapid method that offers a strong return on investment because rapidly testing products that are free from bioburden >95% of the time means you can get >95% of your products to market quickly. This leaves you ample time to focus on the <5% of exceptions.
  5. Can the Celsis® system be used to test samples without incubation or enrichment (i.e., real-time test)?Yes, Celsis® systems can be used to test directly for gross contamination. We have several customers doing so right now—for meat, egg harvest fluid and municipal water.
  6. Can your system detect stressed cells, spores and anaerobes? 
Yes. The traditional method and Celsis® method are both growth based. If you have validated your traditional method to detect these cells, when the growth conditions are met, Celsis® will detect them too.
  7. Can RLUs be correlated with CFUs?
 It is not recommended. RLUs do have a linear relationship to the amount of ATP in a sample, but the amount of ATP depends on the type of organism, its health, incubation time, etc. Since you don't know what is in the sample prior to testing (mixed culture, stressed or environmental organisms, for example), you can’t accurately correlate RLUs to CFUs. If there are CFUs present, however, the Celsis® system will detect them.