Consumers want quality assurance and the FDA is backing them with their cGMP guidelines. Many manufacturing companies are choosing to build in-house programs or signing up with contract labs to beat their existing microbiology quality assurance practices. As a manufacturer, you should always be prepared to test your raw materials and products for unacceptable levels of certain microorganisms.
Solutions include nutraceutical
microbiology testing equipment and rapid detection systems designed
especially for the industry for in-house use or as a supplement for current
testing. Automated microbiology testing is the easiest, most cost-effective and
time-efficient way of carrying out the following tests.
Microbiological
Environment/Stability Testing
Microbiological
environment/stability testing is the most common kind of quality
testing in the nutraceutical industry. Monitoring activities include checking
air samples of your facilities, glove prints and other equipment for
contaminant particles. Surfaces of the walls, floors and surfaces which come in
contact with your product should also be tested for contaminants with touch
plates and swabs. Stability testing such as physical testing, assay testing,
development of stability indicating assays etc. are also possible.
Raw
Material and Final Product Testing
Final products as well the ingredients
that go into them should be tested for relevant microorganisms. Monograph
testing is the most common method available which uses compendial testing
methods. These follow the standards that are set by the US/NF, EP, BP, JP and
other global pharmacopeias.
Compendial methods include moisture
analysis and microbial testing through aerobic microbial count tests, combined
molds and yeast count tests, enterobacterial count tests and tests for other
organisms like E-Coli, salmonella, staphylococcus aureus and pseudomonas
aeruginosa. Other tests include the residual solvents, heavy metal,
chromatographic identification and quantification tests.
Probiotic testing is also an important
aspect of quality testing in facilities that manufacture probiotic supplements.
According to a news report at The
Daily Beast, ConsumerLab tests in 2009 on probiotic
supplements found that they may actually contain only about 10 percent to
58 percent of the good live bacteria that is mentioned on the label. This is an
error on the part of manufacturers which may be a result of poor quality
assurance tests, a situation that most manufacturers will want to avoid.
In-House
Testing
While it is not common for
manufacturing companies to carry out all their microbiology tests in-house, you
may want to carry out a few of the essential microbiology tests in the labs of
your own facilities. For such tests, automated nutraceutical microbiology
testing instruments will make it easy for non-chemical analysts and biochemists
to carry out the tests themselves. This will reduce the need for extra
personnel, cuts costs and also increase accuracy in testing.
With the help of nutraceutical rapid microbiology detection
systems you can monitor microbial counts and retrieve results within a very
short period of time. It is no longer necessary to wait for days before lab
results are released after manual processing. In fact, more people are
switching to automated equipment for in-house testing. You can offer your
consumers greater product standards if you have a quality assurance program
that is cutting edge.
Learn more about nutraceutical,
pharmaceutical, and other microbiological quality assurance testing methods by contacting Biolumix.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
