Frequently Asked Questions

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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.

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?
  6. Will ATP work with my products?

Implementing a Celsis system

  1. How long does it take to implement a Celsis system?
  2. What's included in the Celsis system?
  3. What materials are needed other than the instrument?
  4. What products can be tested with Celsis?
  5. Can Celsis test natural or organic products?
  6. 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?
  3. Who has validated your system?

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. 

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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. 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, the Celsis system provides accurate results in 18-48 hours. The time savings for sterile product testing are even greater. If you have not been testing your products for microbial contamination, know that Celsis has been used successfully by major manufacturers of consumer products, food and beverage products, and pharmaceuticals for 20 years, testing a wide range of products from solids to liquids-- including dark and viscous material like mascara and infused fabrics such as antibacterial wipes. Our experienced lab professionals are available to answer additional questions. Just use our Contact form to start a conversation.

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3. 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; a non-destructive test method that will preserve your 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.

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4. Is ATP an accepted technology?
Yes. 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 AMPiScreen. This exclusive, amplified-ATP technology delivers results in as few as 18-24 hours, up to 50% faster than standard ATP and 80% faster than traditional methods.

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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. 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 and energy and water used by the testing process.

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6. Will ATP work with my products?
The best way to find out is to contact us. Chances are we 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.

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Implementing a Celsis system

1. How long does it take to implement a Celsis system?
When you purchase a Celsis system, included is a three day, on-site installation process covering the IQ/OQ (installation/operation qualification), training and the start of validation. At the end of the three days, the Celsis hardware and software will be installed, your team will be trained, and your product validation will be underway. 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.

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2. 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.

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3. 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, pipettors. Reagents are purchased from Celsis. You can choose to make or purchase broth.

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4. What products can be tested with Celsis?
The flexible Celsis system will successfully test more products than any other method. Only Celsis rapid detection systems can test filterable and non-filterable products; solids; opaque, turbid and highly pigmented 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.

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5. Can Celsis test natural or organic products?
Yes. Many of our customers’ products fall into these categories.

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6. 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. If you don’t usually see a count, then you won’t usually have a "positive" result with the Celsis system either. That means the vast majority of your products can be released quickly and you will generate significant savings for your company. Celsis can also help you make a better quality product by identifying problems--such as a particular ingredient from a supplier or internal equipment or processes that may be adding bioburden.

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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.

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2. 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 return on invested capital and five-year net present value (NPV). The Impact Assessment was developed by the international management consulting firm Arthur D. Little, Inc. for a global consumer products company. That company is now using Celsis in more than 40 of its plants worldwide. Contact Celsis for your free assessment.

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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.

Compares cost per test of traditional vs Celsis rapid method

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4. 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.

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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 pages.

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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 (NDAs). Our two drug master files (DMFs) on record with the FDA will save you considerable submission paperwork. Celsis also has a regulatory compliance experience to help you navigate your global regulatory and governing bodies worldwide, making the approval process relatively fast and painless.

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3. Who has validated your system?
P&G, Colgate, Unilever, GSK, Johnson & Johnson, FreislandCampina, Abbott Nutrition, Natura, and other leading companies all over the world have validated, and continue to use, Celsis systems for faster product release.

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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 or degree is required to interpret the assay.

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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. 

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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, spending all the extra time, using all the extra broth, and requiring all the extra steps of traditional testing. No equipment is needed to identify colony forming units that do not form. 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.

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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.

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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.

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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.

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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.

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