BASECLEAR QUALITY SOLUTIONS
BaseClear Quality Solutions is a specialised Business Unit offering QA/QC-related services. With more than twenty years of experience, BaseClear Quality Solutions is a reliable and experienced partner for quality control testing and the quality assurance of food, as well as biotechnological and pharmaceutical products. BaseClear Quality Solutions offers a complete portfolio of molecular-based rapid testing services which are validated and GMP and ISO compliant. Our services include bacterial and fungal identification, microbial typing, mycoplasma detection, cell line identification and viral testing. Non-standard samples formats or very fast delivery times are no problem for us, flexibility is highly valued within our company. Whether you are in need of a back-up laboratory or are aiming to fully outsource your microbial identifications, BaseClear is the partner that you are looking for.
ISO AND GMP COMPLIENT LABORATORY
BaseClear is an accredited laboratory which is completely organized according to the ISO17025 standard. All our QA/QC services are ISO and GMP compliant. They will meet the quality level that you need and will fit perfectly within your quality system. We make use of validated kits and protocols, and compare the obtained data with validated databases. In this way we can ensure that you get the most reliable results that are in compliance with the global current Good Manufacturing Practice (GMP) as well as regulatory requirements and recommendations of the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Japanese Ministry of Health, Labour and Welfare and other regulatory agencies. Our GMP-certified testing services are available via our subsidiary company ProBase Pharma.
A microbial contamination problem should be solved as soon as possible, in order to prevent a long-term manufactory shutdown or product recalls. Therefore we offer our clients the possibility to choose for our fast services. For several services we can offer a guaranteed delivery time of 1 day! The exact delivery time varies for the different services, please contact your account manager to discuss the possibilities.
UNIQUE COMBINATION OF RAPID IDENTIFICATION METHODS
BaseClear Quality Solutions uses rapid molecular-based tests for the identification and characterization of unwanted microbes. While conventional methods can be very time consuming, BaseClear offers modern identification technologies that are much faster and far more accurate. BaseClear offers a unique combination of two different technologies: the MicroSEQ® system from Applied Biosystems and the VITEK®MS from BioMérieux. The MicroSEQ® system is based on PCR and DNA sequencing of the 16S rRNA of bacteria and the D2-LSU DNA region of fungi, using validated kits and protocols and validated databases. The VITEK®MS system offers possibilities for an extremely fast and reliable identification, based on MALDI-TOF mass spectrometry. This system is 30-40% more accurate compared to traditional phenotypic methods. Data delivery is even possible within hours!