Microbiological Services
Comprehensive microbiological testing for patient safety
QbD Group provides expert microbiological testing and validation services to ensure the purity and safety of your raw materials and finished products.
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.
Why are microbiological services essential?
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 for proactive solutions.
Environmental control
Monitors and maintains cleanroom standards.
How can QbD Group help?
Our laboratory holds a GMP license, an ISO 17025 certificate, and is audited by the Belgian FAGG.
Routine microbiological testing
TAMC, TYMC, and pathogen exclusion for raw materials and finished products.
Specialized testing
PET, endotoxin measurements, and antibiotic assays.
Environmental monitoring
On-site assessments of air, compressed gases, and surface contamination.
Validation services
Ensuring the suitability and accuracy of microbiological methods.
Water quality analysis
TOC, conductivity, and microbiological purity testing for pharmaceutical-grade water.
On-site support
Hands-on assistance for environmental monitoring and sampling.
Our process
A rigorous, GMP-compliant workflow for microbiological testing.
1. Consultation
Defining your testing program and regulatory needs.
2. Sample collection
On-site or in-lab sampling with proper handling protocols.
3. Analysis
Testing under controlled conditions with validated methods.
4. Reporting
Comprehensive reports with actionable results and recommendations.
Why QbD Group
Your trusted partner
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.
Tailored approaches
custom strategies aligned with your unique requirements.
Let's talk Lab Services
From method validation to stability testing, our lab experts are ready to support your analytical needs.