Technical FAQs

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Have a technical 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.

Installing a Celsis system

  1. What's included in the Celsis system?
  2. How will I know if the Celsis system will work with my product(s)?
  3. How long does it take to implement a Celsis system?
  4. What materials are needed other than the instrument?

The technology

  1. Will ATP work with my products?
  2. Is ATP an accepted technology?
  3. How do I purchase reagents? Which ones do I need?
  4. Is the system more sensitive than traditional testing? Will I get more “positive” results?
  5. Can the Celsis system be used to test samples without incubation or enrichment (i.e. real-time test)?

Validating your system

  1. How do I validate the Celsis system?
  2. Who has validated your system?
  3. Can I use Celsis if my product is controlled or regulated?

Your test results

  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 system detect stressed cells, spores and anaerobes?
  6. Do RLUs correlate with CFUs?


Answers

Installing 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.*
*Included in purchase of Accel Pharma and the Advance II systems. On-site installation and training is available for a fee with the purchase of a Celsis Accel system.

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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. How long does it take to implement a Celsis system?
When you purchase a Celsis Advance II or Accel Pharma 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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4. 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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The technology
 

1. 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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2. 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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3. 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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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. 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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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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Validating your system
 

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. 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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3. 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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Your test results
 

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 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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6. 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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