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. Microbial contaminations 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 Quality Solutions can help you to fulfil these requirements. We are specialized in very fast identifications of microbial contaminations using state-of-the-art molecular methods. If necessary, we can deliver your results within 1 day, or even within a few hours (e.g. with MALDI-TOF identification)! 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 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, delivery time and support you need.

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RAW MATERIAL 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 Quality Solutions 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.

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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 Quality Solutions 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. MLST typing offers the advantage that the sequence data are unambiguous and the MLST 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 our Quality Solutions business unit. In addition he is site-manager of ProBase Pharma, the daughter company of BaseClear for GMP certified rapid molecular testing.

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