In the ever-changing pharmaceutical
industry, competition is rife when it comes to the speedy development of
products. Microbiological
testing is essential to ensure safe products are made without any
environmental hazards and at a reduced cost. This has led to an increased use
of rapid detection kits that cut costs and time in detection of pathogens in
any given sample.
Furthermore, these rapid detection kits are able to
detect pathogens in a smaller test sample than most conventional methods used
to require. The instrumentation and rapid detection kits used in testing raw
materials in process material and finished products in pharmaceutical companies
have to be effective with efficiency close to 100 percent.
Microbiology
Quality Assurance
These are activities within the
microbiological laboratories that ensure that various tests carried out are
valid with accuracy close to 100 percent. Microbiology quality
assurance puts emphasis on the various quality assurance systems that form
the standard for quality within a microbiology laboratory.
Pharmaceutical
Microbiology
These are tests done on pharmaceutical
products to ensure sterility in the process and the final products.
Pharmaceutical microbiology aims to ensure pharmaceutical products don’t
contain toxic levels of pathogens such as bacteria, yeast and molds.
Microbiology
Instruments
These are equipment used in any typical
microbiology laboratory. These microbiology instruments include an
autoclave, incubator, water bath, PCR machine, Petri dishes and wire loops
among others. Sterility is vital in ensuring the instruments work with utmost
accuracy.
Pharmaceutical
Microbial Tests
These tests are done to ensure toxic
levels of bacteria, yeast, and molds are in check. The various tests include
sterility testing, bacterial endotoxin testing, total combined molds and yeast
count, preservative efficacy testing and microbiological antibiotic assay.
These tests are important in ensuring
microbiology quality assurance in the pharmaceutical laboratory.
Microbiology
Quality Assurance Control
The various microbial tests require instrumentation for
testing and rapid detection kits to control quality and be assured of
quality. These should be able to provide results within the shortest time so as
the pharmaceutical processing of products is not delayed. The detection of the
microbes should be specific to a procedure and to a single microbe for easier
control and prevention. The assays used in the rapid
test kits should be placed in vials that enable easier testing and complete
sterility.
The instrumentation used is meant to
provide an automated certificate of the full analysis within less than 48 hours
in accordance with U.S. pharmacopoeia standards. This is important for future
references in creating a log to monitor the process.
Furthermore, the data compiled from the
tests should be automatically stored and protected. The instrumentations should
be able to validate from the raw materials, processing to the product. This is
what entails having a quality management system in place to check the input,
processing and the output.
A good company will be able to help a
pharmaceutical company in validation of installation qualification, operational
qualification and performance qualification of the various pharmaceutical
instruments. This is in line with 21CFR parts 210 and 211.
For any pharmaceutical company, getting the best instrumentation and
rapid detection kits is essential for microbiology quality assurance. Any
pharmaceutical microbiology laboratory has to ensure they get their tools and
supplies from a knowledgeable company. These instruments can set the difference
in providing quality pharmaceutical products.
Learn more about microbiology quality assurance and
pharmaceutical microbiology by contacting Biolumix.
Biolumix
3928 Varsity Dr.
Ann Arbor, MI 48108
Phone: (734) 984-3100
Fax: 734-222-1830
Email: info@mybiolumix.com
