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Microbiological Services - Lab Services - QbD Group

Microbiological Services

Comprehensive microbiological testing for patient safety

At QbD Group, we provide expert microbiological testing and validation services to ensure the purity and safety of your raw materials and finished products. With state-of-the-art methods and an experienced team, we help you meet regulatory requirements and protect patient health. From routine testing to specialized projects, QbD Group is your trusted partner for microbiological services.

What are microbiological services?

Microbiological services encompass a range of testing and validation methods to assess and maintain the purity and safety of pharmaceutical products and manufacturing environments. These tests ensure compliance with stringent regulatory standards and safeguard the quality of your products. Key services include:

  • Microbial count (TAMC & TYMC): Measuring total aerobic microbial count and total combined yeast and mold count.

  • Pathogen exclusion: Ensuring the absence of specified harmful microorganisms.

  • Preservative efficacy testing (PET): Assessing the effectiveness of antimicrobial preservatives.

  • Microbiological assays: Quantifying antibiotic potency.

  • Endotoxin testing (LAL Test): Detecting bacterial endotoxins.

  • Particulate matter analysis: Measuring visible and subvisible particles.

  • Water analysis: Testing water for pharmaceutical use, including TOC (Total Organic Carbon) and conductivity.

  • Growth promotion testing: Verifying the performance of culture media.

  • Environmental monitoring: Assessing contamination in air, compressed gasses, and surfaces.

  • Validation of microbiological tests: Ensuring accuracy and suitability of microbiological methods.

Stability Studies - Lab Services - QbD Group (2)

Why are microbiological services essential?

Microbiological testing is critical for ensuring:

 

  • Patient safety: Prevents contamination and ensures product safety for end-users.

  • Regulatory compliance: Meets the stringent requirements of global regulatory authorities.

  • Product quality: Maintains the integrity and efficacy of your products.

  • Operational confidence: Identifies potential contamination risks, allowing for proactive solutions.

  • Environmental control: Monitors and maintains cleanroom standards, safeguarding manufacturing processes.

QbD Group offers a comprehensive range of microbiological services tailored to your specific needs. We have well-trained microbiological experts to support you in your testing program. Our laboratory holds a GMP license, and an ISO 17025 certificate, and is audited by the Belgian FAGG.

Routine microbiological testing

Routine microbiological testing

TAMC, TYMC, and pathogen exclusion for raw materials and finished products.

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Specialized testing

Specialized testing

PET, endotoxin measurements, and antibiotic assays.

Environmental monitoring

Environmental monitoring

On-site assessments of air, compressed gases, and surface contamination.

Validation services

Validation services

Ensuring the suitability and accuracy of microbiological methods.

Water quality analysis

Water quality analysis

TOC, conductivity, and microbiological purity testing for pharmaceutical-grade water.

On-site support

On-site support

Hands-on assistance for environmental monitoring and sampling.

Microbiological Services - Lab Services - QbD Group (1)

Why partner with QbD Group?

When you choose QbD Group for microbiological services, you benefit from:

  • Expertise: Decades of experience in microbiological testing and validation.

  • Advanced facilities: State-of-the-art laboratories equipped with cutting-edge technology.

  • Regulatory knowledge: Thorough understanding of global compliance standards.

  • Comprehensive solutions: From routine testing to complex validations, we handle every aspect.

  • Tailored approaches: Custom strategies aligned with your unique requirements.

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