Contamination is a pervasive cell culture problem and sometimes with very serious consequences. Bacteria, fungi, mycoplasma and yeast are the common sources of biological contamination. Sterility testing is used to demonstrate the presence or absence of contaminating microorganisms. It is very important during the manufacture of biologics, pharmaceuticals and medical devices. Sterility testing has been required as an official test for pharmaceutical articles. Reliable and adequate sterility testing results are critical to quality assurance issues.
Sterility testing is a tedious process that must be performed by trained and qualified laboratory personnel in an isolator or cleanroom environment. Creative Bioarray has experienced scientists, state-of-the-art technique and qualified testing environment to provide comprehensive and reliable sterility testing services. We can help you confirm that cell cultures, therapeutic cell preparations, reagents, biologics and pharmaceuticals are free from viable microorganisms. Our sterility testing capabilities include but not limited to the following:
Contamination may be masked by interfering/inhibiting factors existed in the test article. Prior to sterility testing, it is better to perform the bacteriostasis/fungistasis (B&F) testing to demonstrate the absence of elements that may interfere or inhibit microbial growth in test articles; otherwise, the result of sterility testing may be false negative.
A small mumber of microorganisms are inoculated with the test article in appropriate medium to confirm that the test article does not interfere or inhibit the growth of microorganisms. The B&F testing is the validation of sterility testing.
The test article is filtered with membrane filtration. Microorganisms retained by a 0.45 μm or 0.22 μm pore size filter is cultured in appropriate medium. During 14 days of incubation, the presence of microbial growth is daily checked.
The advantage of this method is that the substances that may inhibit the growth of microorganisms can be removed with appropriate agents. This method is suitable for samples containing bacteriostatic, fungistatic or preservative compounds.
The test article is inoculated directly into the aerobic and anaerobic microbial media, respectively. The evidence of microbial contamination is detected during and after 14 days of inoculation.
The advantage of this method is that a smaller volume of test article can be used. This method is usually used for non-filterable test articles.
Creative Bioarray provides sterility testing services in accordance to the guideline of USP, EP, BP and JP. We have leading-edge sterility testing procedures and standard clean rooms. Our scientific team can customize solutions according to the specific requirements of our customers. We provide sterility testing services in an efficient, high-quality and cost-effective manner.
If you are interested in our services or have any questions, please feel free to contact us. We look forward to working with you in the near future.