Frequently Asked Questions
Do you have a question?
Below are answers to those often asked by individuals researching Rapid Detection and Celsis.
If your question is not answered here, please contact us or give us a call.
Customers can access additional FAQs in the MyCelsis section of the website.
- Why is Celsis better than current (traditional) methods?
- How much does a system cost?
- What is the typical return on investment (ROI) from implementing Celsis?
- How can I predict my company’s return on investment?
- How does the cost per test measure up versus traditional testing?
- What products can Celsis test?
- How will I know if the Celsis system will work with my product(s)?
- Will ATP work with my products?
- Can Celsis test natural or organic products?
- Can I use Celsis if my product is controlled or regulated?
- How long does it take to implement a Celsis system?
- How do I validate the Celsis system?
- Who has validated your system?
- What should I look for in a system?
- What's included in the Celsis system?
- Can we test your system onsite before purchasing?
- What materials do I need other than the instrument?
- How do I purchase reagents? Which ones do I need?
- Is the system more sensitive than traditional? Will I get more “positive” results?
- What are the results and how are they interpreted?
- Isn’t ATP is an old technology?
- I’ve heard ATP/RMMs are difficult to use. Is this going to be a problem with the Celsis system?
- Does your system give direct results on the number and type of organisms present?
- Does your system enumerate? I need counts.
- We need to quantify. Does your system provide this?
- Can the Celsis system be used to test samples without incubation or enrichment (i.e. real-time test)?
- Can your system detect stressed cells, spores and anaerobes?
- Can you correlate RLUs and CFUs?
1. Why is Celsis better than current (traditional) methods?
Celsis is a growth-based method that is similar to what you use now, but with significant business benefits. If an equivalent method could save your company money and make your labs more environmentally responsible, shouldn’t you look at it more closely?
2. How much does a system cost?
It’s really about savings, not the cost. You might spend up to $100,000 but your company will save $500,000 in freed-up working capital. You’ll also save by reducing waste and saving energy costs in the lab. The Celsis system is about saving you money and reducing company costs. If we can’t do that, we won’t sell (or lease) you a system. Celsis has a financial and environmental impact assessment that can estimate your savings.
3. 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.
4. How can I predict my company’s return on investment?
The Financial Impact Assessment will provide a highly accurate forecast of the financial benefits to your company from implementing Celsis. Based on company-specific information that you supply, it calculates your ROI and five-year net present value (NPV). The Impact Assessment was developed by management consulting firm Arthur D. Little, Inc. for a global consumer products company. That company is now using Celsis in all of its plants worldwide. Contact Celsis Rapid Detection for your free consultation.
5. How does the cost per test measure up versus traditional testing?
Celsis actually costs less per test than traditional methods. And it will save your company money. Also, think about how much your last recall cost your company. The benefits of a Celsis system actually double during a contamination event.
6. What products can Celsis test?
The Celsis system will successfully test more of your products than any other method. Only Celsis Rapid Detection systems can test filterable and non-filterable products; solids; opaque, turbid and colored products; pulpy, viscous and other difficult-to-test materials. Typically, Celsis is used to ensure the cleanliness of raw materials, in-process or finished goods for release. Some customers use the Celsis system to test directly for gross contamination, alerting them quickly to potential changes in their product or ingredients over time by monitoring the overall microbial load. Celsis can also be used for water testing and cleanroom monitoring.
7. 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. Like the USP microbial test, Celsis is a growth-based method. However, unlike the traditional test that takes an average of 5 days for microbial limits, our system returns accurate results within 24-48 hours. The time savings for sterility testing are even greater. If you haven’t been testing your products for microbial contamination, know that Celsis has been used successfully by major makers of consumer products, food and beverage products and pharmaceuticals for 20 years in testing a wide range of products from solids to liquids-- including dark and viscous material like mascara and infused fabric such as antibacterial wipes. Our experienced lab professionals are available to answer additional questions. Just use our Contact Rapid Detection form to start a conversation with us.
8. Will ATP work with my products?
The best way to find out is to contact us. Chances are we may have already tested similar products or products with similar ingredients. The Celsis system will successfully test more of your products than any other rapid method. We welcome the opportunity to do a baseline and spiking study on your highest volume and highest value products to demonstrate the benefits of faster product release for your company.
9. Can Celsis test natural or organic products?
Yes. Many of our customers’ products fall into these categories. Typically they use the more sensitive (and faster) Celsis AKuScreen assays, which have a stronger signal-to-noise ratio.
10. 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 (NDAs). Our two drug master files (DMFs) on record with the FDA will save you considerable submission paperwork. Celsis also has a regulatory compliance manager who is available to help navigate your global regulatory and governing bodies worldwide, making the approval process relatively fast and painless.
11. How long does it take to implement a Celsis system?
When you purchase a Celsis system, included is our three day, on-site installation process covering the IQ/OQ (installation/operation qualification) and training. At the end of the three days, the Celsis hardware and software will be installed, your team will be trained, and you will be able to use the Celsis instrument. At this point, the remaining implementation period will depend on your internal process and document control requirements. Customers have completed the conversion in three months or more. If your products are regulated by the Food & Drug Administration, more information is here.
12. How do I validate the Celsis system?
The Celsis method is very similar to the traditional method; they are both growth based. There are three steps to validation: sample effects, spiking studies and parallel testing. Read more on our pharma pages.
13. Who has validated your system?
P&G, Colgate, Unilever, GSK, Johnson & Johnson, FreislandCampina, Abbott Nutrition, Danone, Natura, and other leading companies all over the world have validated, and continue to use, Celsis systems for product release.
14. What should I look for in a system?
The name Celsis, of course! It's your assurance of a robust, reliable, flexible and accurate system that will return real value to your company in reduced manufacturing cycle times, smaller inventory and warehouse requirements, and freed-up working capital. Beyond these benefits, some of the key features to look for are: the ability to test a wide variety of your products including filterable and non-filterable samples; an easy-to-use procedure that will be familiar to your current staff and that can be used by non-scientists; a non-destructive test method that will preserve the original samples; training and support where and when you need it; and a fast time to accurately determine the absence of slow-growing organisms. For more information on how to choose the best system for your company, download our white paper: How to Select the Right Rapid Microbial Testing Method.
15. What's included in the Celsis system?
The Celsis system is composed of four parts: the luminometer instrument (hardware); computerized instrument controls and recording (software); proprietary reagents; and global support. The latter includes installation and on-site training, technical support, customer service and, if needed, regulatory support services.
16. Can we test your system onsite before purchasing?
Yes, but the installation and qualification costs are significant. Consider what it is about the system you feel you need to test. You can see the system in use in the Celsis lab, our demo lab or existing customer locations, where available. If you send us samples we can set up a demo using your products.
17. What materials do I need other than the instrument?
You will need a dedicated computer and monitor, plus standard lab equipment including an incubator, shakers, pipettors. Reagents are purchased from Celsis.
18. How do I purchase reagents? Which ones do I need?
Reagents are determined by your product mix and are purchased directly from Celsis or through your authorized distributor.
19. Is the system more sensitive than traditional? 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 screening. If your products are generally clean now, and you don’t usually get a count, then you won’t usually get a count with the Celsis system either. That means the vast majority of your products can be released quickly and you’ll generate significant savings for your company. Celsis can also help you make a better quality product by identifying problems with ingredients or processes that add bioburden.
20. What are the results and how are they interpreted?
The results are clear and color coded: you get a green to “go” so you can release your products. If there is failure due to possible contamination, it is highlighted in red. The absence/presence system means no specialized training or degree is required to interpret the results.
21. Isn’t ATP an old technology?
ATP bioluminescence is the proven, gold standard for product screening and rapid release. In addition to offering this highly stable and reliable method, only Celsis offers patented, AK-amplified ATP. Our exclusive, enhanced ATP method delivers results in as few as 24-48 hours, 25–50% faster than standard ATP and 80% faster than traditional methods.
22. I’ve heard ATP/RMMs are difficult to use. Is Celsis going to be hard to learn how to use?
Celsis offers the easiest-to-use system: it is a very simple and straightforward process that is similar to traditional methods, but much faster. Plus, there are significant advantages to using Celsis over the traditional method. Not only do you get results much faster, but you are freeing up lab space while also minimizing the amount of waste produced by the testing process and reducing related energy and water costs.
23. Does your system give direct results on the number and type of organisms present?
Celsis is an absence/presence test used as a primary screen to release the vast majority of your products quickly. If you currently test your products and many have little-to-no bioburden, then Celsis is a good fit to “lean” your quality department and improve your company’s profitability.
24. Does your system enumerate? I need counts.
If your products are typically clean for release, and you rarely get a count, why do you need to be doing all that extra work, spending all that extra time, using all that extra broth, and costing your company all that extra money? What equipment do you need to “count to zero”? You only need to count growth in product that routinely has growth. If your product does not, it is an excellent candidate for using Celsis as a rapid primary test for fast product release.
25. We need to quantify. Does your system provide this?
If your products test negative 98-99% of the time, enumeration is only useful for 1-2% of your products. The rest of the time (98–99%) you are using up important resources to “count to zero.” Celsis is a rapid method that offers a strong return on investment because screening 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.
26. 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 a few customers doing so right now—for meat, egg harvest fluid and municipal water.
27. 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.
28. Can you correlate RLUs and CFUs?
It’s 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 we don’t know what’s 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.