Bio Monitoring Lunch & Learn Seminars are a convenient and enjoyable way for busy QC professionals and personnel responsible for microbiological monitoring in the pharmaceutical industry to stay on top of regulatory and technological advancements.We will come to your site and provide lunch for all attendees along with in-depth technical presentations.We also understand how Calibration, Preventive Maintenance, and Equipment Repairs affect your operation.We are familiar with the frustration and headaches that can result if these services are not delivered properly and have assembled a team of experienced calibration technicians to help you keep your equipment in compliance and operating at peak performance.If conspicuous growth does not occur within 3 days for bacteria and 5 days for fungi, the test procedure is not valid and must be modified.To demonstrate that the mixture does not manifest antimicrobial activity, carry out the test as described in sterility test procedure, up to the incubation step and add an inoculum of viable cells of the specific bacteria and fungi respectively to FTM and SCDM and incubate at 30 to 35 Growth of each of each of the added microorganisms should be apparent within 48 hrs.Our calibration laboratory is staffed by experienced metrologists.
We would be happy to evaluate your site to provide you with a complimentary assessment of your project needs.
After incubation of the media has been completed in accordance with the instruction given in the sterility test for negative control, add to representative tube containing FTM that has been incubated at 30-351.
If the conspicuous growth is observed within 3 days for bacteria and 5 days for fungi, and the growth of each challenge microorganisms in the Positive Product control containers are visually comparable to the growth in the positive control and there is no growth in negative control & negative product control, the product possess no antimicrobial activity under the condition of the test or such a activity has been satisfactory eliminated.
All logic processes and verification rules are constructed in middleware with reference to the CLSI Auto10-A Guideline.
There were 569,001 patient test results collected to establish the range of the limit check, delta check, and the consistence rule check.