Why go to an automated system?
There has been a growing awareness over the years that utilizing the current methodology for determining microbial contamination is not cost effective due to the slow turnaround. Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM’s) can speed up significantly the time to results from 7-10 days to 15-48 hours. An automated detection system provides contamination information earlier than the conventional method, products can be released faster, manufacturing at risk is minimized, and investigations can be conducted and concluded closer to the time of the actual contamination. The obvious benefit of an automated system is the quicker release of finished products, where the shorter ‘time to result’ may generate considerable cost savings. Some of the other advantages of RMM can include greater accuracy, better sensitivity, increased sample throughput, and automated data capture allowing easier data handling and paperless laboratory.
Why You Should Invest in the BioLumix System?
Time is money. For a nominal investment in automation, the BioLumix Rapid Microbiology System will save valuable days in the QC process: optimize operations; increase throughput; and directly impact company profitability! The BioLumix system allows for all of your microbiology needs to be met with one automated system. It can be used to test Raw, In-process, and Finished Materials along with environmental and water samples. The BioLumix system allows the user to test as frequently and as broadly as desired without significant cost or delays. The results are increased capacity along with cost reduction, improvement of logistics, and overall better efficiencies! With shorter sample preparation time and automated data entry, data archiving, report generation, and product release, the BioLumix system simplifies and automates your laboratory procedures. Tests can be also be performed by non-microbiologists, providing significant savings in laboratory labor.
Advantages of the BioLumix System
1) All assays performed on a single system. This allows laboratories to purchase one system but offer and perform many different tests, thus eliminating the problem of finding space for multiple systems in the lab and training personnel on multiple instruments.
a) Microbial results can be generated in 24-48 hours in assays such as Total Aerobic Count, Yeast and Mold, Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa while utilizing one system. The system is unaffected by product interference and delivers accurate results. BioLumix is dedicated to producing affordable and easily performable assays that laboratories of all sizes can integrate into their daily work flow and yearly budget.
b) BioLumix has improved the way microbiology can be performed in the cosmetic, toiletry and pharmaceutical industries. BioLumix offers the first automated PET and Microbial Limits system on a single platform, without any product interference! Preservative Efficacy Testing or Challenge Testing (USP<51>), Microbial Enumeration Testing (USP<61>), and Testing for Specified Microorganisms (USP<62>) can be easily performed without the hassle of preparing and counting multiple plates that would be expected using the standard methodology yielding faster results and being more cost effective.
c) Environmental Monitoring. In manufacturing facilities there is a need to demonstrate that the production equipment and environment are sufficiently clean so that the next production lot will not be contaminated by the material from the previous lot, removing the potential of cross contamination. One needs to prove with high degree of certainty that the cleaning process was effective. To do so an effective sampling plan needs to be established. The BioLumix system can be utilized for rapid and simple monitoring of the manufacturing environment.
d) Water Testing. Water is widely used as a raw material, ingredient, and a solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients and intermediates. As such, all water purification systems must be monitored regularly to verify the quality of the water produced. Monitoring of water for microbiological quality may include testing for total heterotrophic plate count, coliforms/E. coli, or by checking for the presence of other organisms suspected to be present in a water sample. The relevant standards relating to pharmaceutical grade water are USP <1231> Water for Pharmaceutical purposes.
2) Scarcity of skilled personnel: Microbiology laboratories face major challenges such as the growing scarcity of skilled laboratory workers and the burden of the ever-increasing workload. The BioLumix system requires limited training to successfully set up the tests. The system is fully automated including archiving of data, data maintenance and report generation, and it can be used to create a paperless laboratory.
3) In house testing allows a laboratory to be more cost effective. Increased turnaround time may be one of the most appealing features of an automated system. Contamination can be caught quicker and actions can be taken immediately so that products can be released faster into the marketplace.
4) The Validated BioLumix System. Since June 25, 2010, all dietary supplement manufacturers have been required to comply with the Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP’s) according to the guidance outlined in USP chapters <2021>, <2022>, and <2023>. The BioLumix system has software that is 21 CFR Part 111 compliant and BioLumix generates a customized validation book for each of its customers that include:
a) Installation qualification (IQ): Identification and validation of the system components; validation of the environmental conditions; electrical requirements; computer qualification; verifying that all installation steps were followed; and documentation of instrument calibration.
b) Operational qualification (OQ): Verifying that the equipment is properly installed calibrated and is operational. It includes a unique SOP for all products and assay combinations to be performed on the instrument; software characteristics and the verification that the software is 21 CFR part 11 compliant; verification that all the instrument functions operate as expected; Verification of the instrument temperature accuracy; and training records.
c) Performance qualification (PQ): is the most extensive part of the BioLumix validation book. It shows equivalency with USP methodology when following USP <1223> “Validation of alternative microbiological methods”.
1) United States Pharmacopeia Chapter <51> Antimicrobial Effectiveness Testing
2) United States Pharmacopeia Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
3) United States Pharmacopeia Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
4) United States Pharmacopeia Chapter <1231> Water for Pharmaceutical Purpose
5) United States Pharmacopeia Chapter <2021> Microbial Enumeration Tests – Nutritional and Dietary Supplements
6) United States Pharmacopeia Chapter <2022> Microbial Procedures for Absence of Specified Microorganisms – Nutritional and Dietary Supplements
7) United States Pharmacopeia Chapter <2023> Microbial Attributes of Non-Sterile Nutritional and Dietary Supplements
8) United States Pharmacopeia Chapter <1223> Validation of Alternative Microbiological Methods