RAPID MICROBIOLOGY METHOD BENEFIT BOTH LAB SERVICE PROVIDER AND MANUFACTURERS

 

 

Manufacturers of Nutraceutical, Pharmaceuticals, Cosmetics, Dairy, and other products are often faced with the challenge of putting their products in the hands of consumers as quickly and efficiently as possible, while at the same time ensuring the quality and safety of their products.  Many of these companies rely on the services of third party laboratories or contract packaging companies to provide timely, accurate microbiology testing of their products and their ingredients.  As a result, organizations who provide these types of services may wish to update their labs with Rapid Microbiology Method (RMM) equipment.  By adding the BioLumix RMM to their laboratories, lab service providers can significantly reduce the amount of time it takes to provide their customers the quality results they need to move forward with their products.

Internalizing microbiology testing: offering speed and automation

WePackItAll®(WPIA) is a leading contract packaging and service company, combining their customers’ products with their packaging technology and resources to provide customized and affordable solutions.
WPIA are experts in all types of packaging, including: Packets, Gummies, Multi-Packs, Tubes, Stick-Packs, Blisters, Powders, Liquids, Tablets, High-Speed Bottling and more.

Lab Quality Assurance“WPIA is honored to be celebrating our 40th year in business, serving the dietary supplement, nutrition, food and health/beauty industries, and we are so thankful for the many people and business partners that have contributed to our success over the years.  I have the great pleasure of working with an amazing group of professionals every day and without a doubt, they are the biggest reason WPIA has been so successful over the years.” says Dave Hoover, COO.

In the beginning of 2013 WPIA launched its in?house laboratory, offering microbiological testing services to meet testing requirements and serve the needs of their partners. WPIA chose the validated BioLumix system for their microbiological testing.

We recently interviewed Suren Zatikyan, Quality Assurance Lab Analyst, and Kristopher Flores, Quality Manager.

BIOLUMIX: Why did you decide to add the BioLumix system to your lab?

SUREN: 
The reason we decided to get this system is that it helps us provide our customers with the best service.  Because we are a contract packaging company, we need a finished product testing schedule and quick microbiology results that will prove that we have a clean operating environment in our facility and ensure product safety when the product reaches the consumer.  That was our primary goal when looking at microbiology instruments.

BIOLUMIX: What were some of the things that impressed you the most about the BioLumix system?

BioLumix VialsSUREN: When we found out about BioLumix, we discovered it gave us the opportunity to generate results in a very short period of time.  In addition, validation studies that were performed by BioLumix, and later on by us, proved that the system itself is compatible with all the standard methods used by USP and other standard methods developed for microbiology labs.  We use the BioLumix system to perform some of our environmental testing and monitoring programs, which is very helpful to us.

BIOLUMIX: What has been your experience while working with BioLumix?

SUREN: We were very pleased with the explanation given to us on how the system works, both in terms of capabilities and which tests can be performed.  The tests available were the most important assays that we needed such as Salmonella, E. coli, Staph, Yeast & Mold, and Total Aerobic Count.  These are tests used on a daily basis.  Jason Kircos, a BioLumix microbiologist, was very helpful during the initial 2 1/2 days of training and later on – whenever we needed any information regarding specification values and the use of the software.  We had an issue with the computer hard drive, and the technical team was very helpful.  Not only did they provide good technical support, but they also sent us brand new replacement computer.

BIOLUMIX: What else would you like to add?

SUREN:  We occasionally have some false positive results, due to the sample we are working with, such as samples with high counts because of their botanical nature.  Some organisms can be closely related to what we test for.  We have our own protocols in place when we see positives and have confirmation tests.  We can also use third party labs for identification, as needed.  There haven’t been any real issues with the system that we were not able to resolve quickly.  There’s never been any major issue which caused us to stop processing and troubleshoot because the system was unreliable.

BIOLUMIX: Were there any marketing strategies for promoting your services with the BioLumix system?

Absolutely.  Because BioLumix is more or less an all-in-one package, and given the timeframe it takes to package a product, we really do not have to increase lead times for micro testing.  That is definitely a selling point.  We placed some information about BioLumix on our website, and also created brochures to promote rapid microbiology in conjunction with some of the other quality systems at WPIA.  This is a value-add for our customers.

BIOLUMIX: Did you see any measurable increase in your overall business?

KRISTOPHER: While it is difficult to quantify the impact in that manner, it certainly plays a part in our overall offering to our customers and with our compliance requirements.  I deal with all of the customer audits and having finished-product testing capabilities as it relates to microbiology is a selling point.  To measure it would be a little tougher to do.

SUREN: Whenever you can add into the conversation that we can perform these tests, it’s a selling point.

KRISTOPHER: Our larger customers require it as part of their day-to-day release process.  If the BioLumix system wasn’t in place, it would be tougher to support their needs.  In some instances, based on our testing and our customers’ testing, we’ve been able to validate our processes in-house and eliminate third party validation.  That makes an impact on the bigger picture for our customers.

SUREN:  Sometimes our customers ask if specific counts (CFU) can be generated whenever specifications are given.  However, once we explain the method used most of them are satisfied that BioLumix is not a number-specific CFU “count.”  Validation BookWe create the specification based on specific values and if the test result is below spec then it passes.  If it’s above, then it fails.

BIOLUMIX: Audits – how has the BioLumix system held up under scrutiny during any audits you may have had?

KRISTOPHER: It has certainly been under scrutiny, but the validation package that was prepared at the start definitely goes a long way and satisfies any curiosity when it relates to our customers.  We have also had the local California Food & Drug branch here a few times and they checked the system,finding no inconsistencies.

SUREN: The Validation Book is very thoroughly prepared.  IQ, OQ, PQ validations, the prior testing by BioLumix, and our own validation shows equivalence with the USP methodology.  Everything was very well done and documented.

KRISTOPHER: When I get larger more experienced customers that come to WPIA with very developed systems and very experienced personnel, they take a look and they are thoroughly impressed.  In some instances there are some questions, but they’re resolved on the spot.

BIOLUMIX: Would you say your customers are satisfied?

KRISTOPHER: Absolutely.  Continuously, our customers tend to move more toward this type of testing compared to what they have been accustomed to in the past.  The reductionin time to get results with this system makes the difference.

SUREN: In general, I would say we are quite satisfied with the BioLumix system.  The duration of the tests are very short compared to other methods.  We are capable of delivering products that are safe and we have peace of mind when we perform our tests.  Overall, we have a very successful operation and a cost-efficient system when compared to other options.

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Kristopher Flores has been the Quality Manager at WePackItAll since 2012.  Prior to that, he was with various other contract manufacturing facilities in aerospace and nutraceutical.  Kristopher has extensive knowledge in Quality Assurance, Regulatory Affairs, and Project Management.

Suren Zatikyan has been a Quality Assurance Analyst at WePackItAll since 2012. Graduated from Cal. State University of Northridge (CSUN) with B.A. in Biology. At CSUN was part of undergraduate cancer research program. Prior to WePackItAll, worked in Michelson Laboratories.