Soleris and BioLumix – when to use which system

By Joseph Heinzelmann

As the need for rapid microbiological testing in various industries continues to grow, Neogen’s recent acquisition of BioLumix helps provide new resources to an already successful rapid microbiological testing product. Specifically in the nutraceutical, dietary supplement, cosmetic and pharmaceutical markets, the BioLumix system serves customers with a system supported by validation datasets, ready to use microbial tests, and Neogen’s excellent customer service. In fact, the value of the system from the perspective of some of our customer’s can be found in their testimonials and feedback. Along with great customer service, some of the key aspects that customers are able to take advantage of include 48-hour certificate of analysis and ready to use assays.

Upon reviewing both the BioLumix system and Soleris, it is apparent that both of these systems offer advantages over other methods and products. These include:

  • Expedited results: most results in 12-18 hours; Yeast and mold assay in 48 hours
  • Automation and connectivity allows faster product release
  • Streamlined testing increases laboratory efficiencies
  • Paperless laboratory: centralized test data automatically stored and protected
  • Ready to use test vials
  • Excellent customer support

The differences lie in the application and validation information supporting both systems. For example, the BioLumix system has submitted a DMF to help aid companies on technical and regulatory information on approvals for prescription drugs. The BioLumix system has an established protocol for preservative efficacy testing, adhering to USP Chapter <51>. Neogen also has the capability to provide services on the BioLumix system, such as suitability testing, USP Chapter <61>.  The BioLumix system comes with uniquely designed validation books for nutraceutical and dietary supplements, cosmetics and toiletry, and for over the counter medication.

Similarly, the Soleris system has been for various food matrices. For
example Soleris has been validated for use in aseptically packed UHT products, dressings and sauces, and many other matrices as supported by the AOAC approvals. Because of the focus over the last few years of Soleris in food matrices, Neogen has developed various tests and applications specifically for food. For example, the 48 hours direct lactic acid vial for dressings and sauces, the orange serum broth vial for low pH and beverage applications, and the alicyclobacillus vial for beverages.

Validation strategies for both systems also varied because of market requirements. For example, in the food industry, companies seeking certain SQF level certifications require an AOAC approval on all methods used. Meaning that food testing validations were done according to the outlines and recommendations provided by AOAC International.

In addition, Neogen’s industry leading customer and technical service are now supported by the microbiological excellence of the staff from BioLumix. Both systems come with packages and programs for installation qualification, operational qualification and performance qualification. Furthermore, both systems have packages available to maintain the system through preventative maintenance programs.

Which system is right for you? It depends on the type of products manufactured, and the requirements. Neogen would be happy to help you understand the advantages of both systems and provide more information that can help you make the correct decision. You can contact Neogen by calling 800-234-5333 or emailing foodsafety@neogen.com.

 

Come and See us at the Natural Products Expo East in Baltimore September 22nd – 24th

This marks our first year exhibiting at the Natural Products Expo East trade show located this year at the Baltimore Convention Center September 22nd – 24th; and thanks to the growing BioLumix customer base we are rapidly becoming a recognizable solution to today’s cGMP microbial requirements.  I wanted to take this opportunity to invite you to our exhibit (booth #4627) at the show and express what’s new at BioLumix.

We have developed a Rapid Microbiological Method that has been validated according to the FDA requirements.  The validated BioLumix system is an alternative to the classic USP methodology.  It is a streamlined testing system which is far less time consuming and requires less skilled technical personnel to operate.  The BioLumix system offers a Certificate of Analysis for all relevant USP assays within just 48 hours.  These include the FDA required tests such as total aerobic count, yeast and mold count, Bile-Tolerant-Gram -negative count, and objectionable organisms such as E. coli, S. aureus, and Salmonella.  This means quarantine time for microbial testing is cut from 5-6 days to 24-48 hours for finished products, in-process and raw materials and environmental work surfaces. 

Currently, the majority of our clients are manufacturers of Nutraceutical and Dietary Supplements. In the past year we have doubled our customer base, many of which are recognizable names in the industry who will also be exhibiting at this year’s Natural Products Expo East. 

In addition to the Nutraceutical Industry, we offer microbial testing solutions to the Pharma – OTC, Cosmetic, and Dairy Industries.  Come to our booth (#4627) or contact us directly (734-984-3100) to learn more about the exciting new developments at BioLumix; such as:  our environmental monitoring and water testing solutions, as well as our labor and material saving Preservative Efficacy Test (PET).   

Fast Return On Investment

An automated Certificate of Analysis is generated in just 48 hours!  Streamlining your microbial testing with our reliable, easy-to-use system will save you time and money.   In most cases a very quick return on investment can be proved.  We invite you to contact us and inquire about our Return On Investment calculation.  We have shown in most cases the BioLumix System will pay for itself within the first 6 months of ownership. 

Hear What Our Customers Are Saying

Don’t just take our word for it, talk to our customers.  We have recently conducted a customer survey and are proud to share we have 100% customer satisfaction and that all of our customers would recommend the BioLumix.  Unanimously, our customers agree – the main features of the BioLumix system are:  Speed to results, simplicity of use, accuracy and clarity of data presentation. You are free to contact our customers to discuss their first hand experience.

Free Product Trial

Give us your most difficult samples and we will test them for free.  We will provide you with a detailed report which includes a side-by-side comparison to USP methodology along with a sample of the BioLumix 48 hour automated Certificate of Analysis.  The data generated is strictly confidential and is only used to help validate the system for your company should you decide to purchase.

We look forward to working with you and earning another satisfied customer!

Rapid Microbiological Method or Conventional Method? What Should You Use?

In the get-it-done-yesterday environment companies are finding that the traditional microbiological methodologies and especially sending microbiological samples to outside labs cost them time, money and opportunities1.  Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM) can significantly speed up the time to results from 7-10 days to 24-48 hours.  The time saved creates opportunities for faster response to contamination, quicker product release, faster delivery of product to the marketplace, reduced warehouse space, and enhanced product quality.  Advantages of RMM can include: Greater accuracy, better sensitivity, increased sample throughput, automated data capturing allowing easier data handling, and reduced cost for product release.

However, like any other investment it competes for company resources.  Therefore, there is a need to calculate the financial benefits of the investment in RMM.

Dr. M. Miller, an authority on RMM, has written extensively on this topic and suggests that before adopting a new RMM or internalizing Microbiology the key steps required include2, 3, 4:

  1. Review of existing technologies
  2. Understand the technical and financial benefits of RMM
  3. Develop the business case for RMM

This will include the use of financial models that can compare the overall costs associated with the current microbiology method with the costs and savings associated with the purchase, qualification, and implementation of the RMM

Return on Investment (ROI)

ROI is the ratio of money gained or lost on an investment relative to the amount of money invested.  According to Dr. Miller3 for RMMs, the cost of performing the conventional method (CM) is compared with the cost (and savings) of using the new method. The information is reported as a percentage and usually represents an annual or annualized rate of return. The ROI is calculated using the following formula4:

CM costs can include:  cost of consumable; reagents and supplies; sample preparation time; data management documentation and record retention time; as well as cost of labor and overhead.

Potential investment in RMM can include:  Capital cost; and validation cost.

Potential cost savings of RMM can include:  Reduced time for product release; Lower headcount; lower re-processing fees; reduction in plant downtime; increased production yields; reduced raw materials, in-process and finished products inventory holding; reduction in back orders; increased production flexibility; and better protection of company image.

Payback Period (PP)

The PP is the time required for the return on an investment to “repay” the sum of the original investment. In the context of implementing an RMM, this would be the time (usually in years) required to realize sufficient cost savings to pay for the initial investment of the RMM capital equipment as well as for qualification and implementation activities3, 4.

Requirements from RMM

While Rapid Microbiological Methods (RMM) offer high degree of automation, significant reduction in time to results, faster product release, ability to employ non-microbiologists to operate the system, and improved control; there are three basic objectives that must be meet:

  1. Comply with FDA and cGMP regulations
  2. The RMM must be validated against the standard USP methodology using a protocol similar to USP <1223>.
  3. Ensure a swift return on investment.

Additionally, the ideal system should be capable of:

  1. Performing all the microbiological assays required to be performed by lab on a single platform.
  2. The technology should eliminate or at least minimize any product interference.
  3. Allow for a paperless microbiology laboratory-allowing the laboratory to operate without handwritten data entries
  4. Automate the system reporting
  5. Real-time communication to locations outside the lab to provide early warning of contamination

Required Commitment from RMM Vendors

Validation:

To make the transition to a rapid method the vendor should help in the system validation to make the transition to the new system smooth and “painless”. It should include Installation Qualification (IQ); Operational Qualification (OQ), and help with the Performance Qualification (PQ). PQ is the most extensive portion of the validation and sometimes companies considering RMM are deterred by the amount of work required for validation. Vendors can generated most of the data and submit it to the FDA in a form of a DMF.  The same information can be supplied to new users together with unique data pertaining to their products.

Software:

The software must be compliant with 21 CFR Part 11.  21 CFR Part 11 regulations are established requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and traditional handwritten signatures. Any instrument system containing software must be compliant with this regulation.

Technical Support:

Instruments suppliers should guaranty live technical service that is fast, knowledgeable, and readily available.

The BioLumix system is an example of a system that fulfills the requirements listed above.  Its straightforward streamlined design offers rapid accurate results leading to reduced material-holding time for faster product release.  Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies.

To evaluate the value proposition of RMM systems BioLumix offers a free assessment of your specific ROI and Payback Period.  This will help you determine whether there are sufficient cost benefits of adopting a RMM system.  Past ROI calculations demonstrated that in many situations the ROI obtained showed that a RMM, like the BioLumix system, improved the company’s bottom line and satisfied the financial expectations of site management.

References

  1. 2009. Gadal, P.; Yvon, P. Rapid Microbio ROI – Calculating scientific benefits as return on investment dollars. Pharmaceutical Formulation & Quality. 11(3): 44-47.
  2. 2009. Miller, M.J. Breaking the rapid microbiological method financial barrier: A case study in RMM return on investment and economic justification. BioPharm International. 22(9): 44-53.
  3. 2009. Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8(6): 32-35.
  4. http://rapidmicromethods.com/files/roi.html
  5. USP <1223> Validation of Alternative Microbiological Methods.

Ruth Eden, PhD

President

BioLumix. Inc.