Among the most critical aspects of
controlling the manufacturing process and providing microbiology quality
assurance in the production process is maintaining the proper use and
application of key testing procedures that were established during the research
and development phase. Conventional methods used to monitor the performance of
analytical procedures range from the use of control samples with known values
for method validation, to the use of titration blanks, periodic calibration and
instrument qualification. In addition, many test procedures can be monitored
using system suitability
tests.
Ideally, it is the assumption that any
analytical test method will perform in a certain manner each time it is used.
Suitability testing ensures that the entire system is working properly at the
time of the analysis, and provides the assurance that the test methods will
deliver accurate and precise data for the intended purpose. As such, system
suitability tests are performed prior to each reading session, in order to
ensure that the equipment, the environment, and
the reagents are functioning as intended. In other words, the test ensures that
the method used does not prevent the growth and recovery of microorganism that
may be present in a sample, thereby making the test valid for the detection of
microorganisms within the product.
The system suitability test selected
for microbiology quality assurance should be dependent on the intended use of
the procedure, the type of analysis, and the stage of development. While the
USP employs conventional microbiology
quality assurance methods, it permits the use of alternative microbiology
methods like automated procedures, as long as you can provide evidence of their
similarity to Pharmacopeia methods. Rapid Methods for suitability testing have
been validated to provide similar results to those of USP methodologies. In
fact, regulators encourage the use of rapid methods due to better process
control and earlier product release.
The test described in USP <61>
requires the use of several methods including pout plating, spread plate and
membrane filtration to perform the Total combined Yeast and Mold and
total Aerobic
Microbial Count tests. This ensures the validity of a testing procedure by
indicating the recovery of microorganisms while in the presence of the sample
product. For instance, a suitability test that seeks to show the use of a
suitable neutralizer would inactivate the preservative in the sample product to
illustrate that microorganisms like molds or bacteria yeast would, in fact,
grow and be detected, if they were present.
For suitability testing using USP
<62>, selective media are used to detect multiple organisms like Pseudomonas aeruginosa,
Staphylococcus aureus, Escherichia coli,
Clostridia, bile-tolerant gram-negative bacteria, Candida albicans and Salmonella. It is extremely important
that microbiologists take the necessary precautions when conducting suitability
tests in order to avoid contamination, so that the microorganisms being tested
are not affected. Basically, you are required to inoculate the neutralized
sample with low cfu, usually less than 100, and using the prescribed method to
detect the organisms.
There are many benefits of the rapid
suitability testing methods, including time and labor efficiency. Traditional
procedures that take 5 days or 48 hours to deliver results, can be substituted
with rapid methods that take less than 48 hours or 18 hours to provide results,
respectively. The assay setup can also be made much faster using rapid methods,
allowing laboratories to save on hands-on labor owing to its simplicity of use
and automation. Contact Biolumix
for more information.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
http://www.mybiolumix.com/
https://plus.google.com/103841943418192727689/
