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.
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.
How can QbD Group help?
Routine microbiological testing
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.
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.