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MONITORING MICROBIAL CONTAMINATIONS

For the development and production of pharmaceutics, biologics and food ingredients, it is important to ensure that the whole production process, from raw materials to final end products, is free of any microbiological contamination. Microbiological contamination can cause recalls and even plant shutdowns, resulting in high costs, loss of public confidence and potential fines. Both the pharmaceutical and food industries are subject to a variety of laws and regulations regarding testing and product safety. Contamination crisis plans require periodic testing for the presence of microorganisms in the environment, raw materials, intermediate products and end products. BaseClear can help you to fulfill these requirements. We are specialized in very fast identifications of micro-organisms using molecular methods such as DNA sequencing (MicroSEQ®) or MALDI-TOF technology (Vitek® MS). If necessary, we can deliver your results within 1 day, or even within a few hours! Depending on the quality level that you need, you can choose our ISO-compliant services, or our GMP-certified services via our daughter company ProBase Pharma.

ENVIRONMENTAL MONITORING

Periodic environmental monitoring is an essential part of the quality control system when manufacturing food, pharmaceuticals or cosmetics. By detecting microorganisms in the environment of your labs, clean rooms or manufacturing plant as early as possible, it is possible to prevent further contamination problems. Moreover, the monitoring of in-house microbial isolates, as an indicator of the normal in-house flora, has become part of the periodic compendial testing and food contamination crisis plans. BaseClear can support you in the environmental monitoring of your company. We can help you determine the optimal identification method, quality level and delivery time and support you need.

RAW MATERIALS, INTERMEDIATE PRODUCT AND FINAL PRODUCT TESTING 

Microbial contaminations are often introduced into the manufacturing process via raw materials. Especially materials of a natural origin can contain an extensive and varied microflora. But also chemical materials can be contaminated with microorganisms. Testing of the raw materials ensures that they are suitable for their intended use and can prevent costly production problems and delays. During the production process, the intermediate products as well as the final products should be periodically checked for the presence of microbiological contaminations. BaseClear can do the complete microbiological testing on raw materials, intermediate products and final products using molecular methods such as DNA sequencing (MicroSEQ®) or MALDI-TOF technology (Vitek® MS). We can help you meet all requirements and guarantee the quality of your products.

ROOT CAUSE INVESTIGATION

In case of a microbial contamination, it is necessary to determine where this contamination came from, i.e. the root cause of the contamination problem. Since different microorganisms occupy a diverse range of habitats, the only way to determine the origin of a contaminating microorganism is to characterize it as a specific strain and match this with control strains, or other strain present somewhere else in the environment. For this BaseClear offers an all-inclusive microbial typing service for root cause investigation. We can do the microbial typing based on Rep-PCR, which is a universal method for both fungi and bacteria. In addition, we offer the possibility to do Multi-Locus Sequence Typing (MLST) on bacterial and some fungal species, which offers the advantage that the sequence data are unambiguous and the profiles can easily be compared with a large central database. We can help you to determine the optimal typing method, quality level and delivery time and help you solve your contamination problem.

Meet Richard de Winter

Richard is director of the Sanger sequencing and microbiology department. In addition he is site-manager of ProBase Pharma, the joint venture of BaseClear and MicroSafe for GMP accredited rapid molecular testing.

Testimonial TEVA Pharmaceuticals

We have implemented the microSEQ system within TEVA whereby we commissioned BaseClear as backup and expert laboratory. This means we can use their services if we need extra capacity or a more extensive identification method in the event MicroSEQ does not satisfy the requirements. Since we are GMP certified, I first had to perform an audit at BaseClear. We were really impressed what we saw. BaseClear is more than qualified for us to be able to outsource materials to them.

Senior Analist Quality Control

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