More than just a microbiological result.
Whether it concerns product development, process validation, or routine quality control, Brightlabs provides support through microbiological analyses in accordance with international guidelines, fast turnaround times, and expert guidance.
Reliable microbiological analyses, tailored to your product and application.
Microbiological expertise for every phase.
Brightlabs performs microbiological analyses for product quality, safety, and compliance with international guidelines.
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Fast turnaround times
Routine microbiological analyses are performed efficiently, ensuring results are quickly available for quality control and product release.
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Method development and validation
When a standard method is not immediately applicable, we provide support with implementation, suitability testing, method development, and validation.
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In accordance with international guidelines
Our analyses are performed in line with relevant guidelines from sources including the European Pharmacopoeia and USP, with expert support from our microbiological project managers.
Expertise
Reliability
Flexibility
Partnership
From method suitability to routine analysis.
Before routine microbiological analyses begin, we determine whether the method is suitable for the specific product. This ensures that the matrix does not interfere with the detection or recovery of microorganisms.
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Determining matrix suitability
With a Matrix Suitability Test, we assess whether the product matrix affects the recovery or detection of microorganisms. This verification supports the application of Ph. Eur. 2.6.12 and 2.6.13 and USP <61> and <62>.
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Selecting the analysis technique
Based on product characteristics and expected microbiological load, we select the most suitable technique, such as the pour plate method or membrane filtration.
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Performing routine analysis
Following successful method suitability, we perform routine quality controls according to the established method and relevant pharmacopoeial requirements.
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Microorganism identification
Isolated colonies can be identified using techniques such as MALDI-TOF MS. This supports activities including deviation investigations and contamination control.
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Result assessment
Results are assessed against relevant product specifications and guidelines, with expert support from a microbiology project lead.
Sectoren waar methodeontwikkeling essentieel is.
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Insights from our laboratory
The complete overview of what Brightlabs does.
Download our brochure for a complete overview of our analytical capabilities, services, and scientific approach.
