Ensuring Safety Through Microbiology Testing
Accurate testing. Safer products.
Our microbiology testing services are designed to verify microbial safety and support product integrity. They help you:
- Verify microbial safety of raw materials, intermediates, and finished products.
- Support product and microbiology method validation (MMV) to ensure testing accuracy and regulatory compliance with over a decade experience microbiologist.
- Meet GMP requirements and stay inspection-ready.
- Support batch release decisions with accurate, validated results.
- Monitor lab environments, equipment, and water to ensure suitability.
- Test preservative effectiveness in non-sterile products as per the requirements.
- Provide audit-ready documentation and full traceability for regulatory compliance.
With expert microbiology services, you can confidently ensure product safety, quality, and compliance every step of the way.
Our Microbiology Testing Capabilities
Comprehensive testing across every product type.
Sciom provides comprehensive microbiology testing services and product validation to ensure pharmaceutical products are safe, compliant, and ready for batch release. All testing is performed in accordance with European Pharmacopoeia (Ph. Eur.) standards and GMP requirements. Our capabilities include:
- Microbiology Method Validation (MMV): Full validation of microbiological methods to ensure accuracy, reproducibility, robustness, and regulatory compliance
- Microbial Limit Testing (MLT): Quantitative and qualitative analysis of microbial load in raw materials, intermediates, and finished products, aligned with Ph. Eur. 2.6.12, 2.6.13, and 2.6.31
- Bacterial Endotoxin Testing (BET): Sensitive endotoxin detection using validated gel-clot methods, ensuring compliance with Ph. Eur. 2.6.14, USP <85>, and GMP standards
- Subvisible Particle Testing: Detection and quantification of particles ≥10 µm in line with Ph. Eur. 2.9.19 and USP <788>
- Preservative Efficacy Testing (PET): Evaluation of antimicrobial preservation effectiveness as per Ph. Eur. 5.1.3
- Water Testing: Microbiological testing of pharmaceutical water systems in compliance with Ph. Eur. and GMP standards
- Environmental Monitoring (EM): Monitoring of laboratory environments, equipment, and surfaces to ensure contamination control and testing suitability
Microbiology Testing Workflow
Tested with precision at every step.
Sample Receipt & Logging
- Receive samples with proper documentation and maintain storage conditions.
- Verify against Ph. Eur. or client specifications.
- Log samples in the system with unique IDs for full traceability.
Microbiology Method Validation (MMV)
- Confirm testing methods are validated, accurate, and reproducible.
- Ensure instruments are calibrated and ready.
- Validate suitability for raw materials, intermediates, and finished products.
Microbial Limit Testing (MLT / Bioburden)
- Measure microbial load in samples.
- Conduct testing under controlled conditions following Ph. Eur. 2.6.12, 2.6.13, 2.6.31.
- Data supports batch release decisions.
Bacterial Endotoxin Testing (BET)
- Detect endotoxins in injectable products using Gel-Clot methods (Ph. Eur. 2.6.14).
- Includes system suitability and spike recovery checks.
- Ensures endotoxin levels meet regulatory limits.
Subvisible Particle Testing
- Identify and count particles ≥2 µm in injectable products.
- Performed according to Ph. Eur. 2.9.19, and USP <788>.
- Ensures product safety and compliance.
Data Review & Approval
- QA reviews raw data, calculations, and results.
- Investigate any out-of-specification (OOS) results.
- Approve only verified and compliant results.
Certificate of Analysis (CoA)
- Generate CoA showing all test results vs specifications.
- Reviewed and signed by an Authorized Person.
- Shared via secure client portal for batch release.
Archiving & Audit Trail
- Securely store all data and CoAs in a 21 CFR Part 11-compliant system.
- Retain records for at least 10 years for audits and inspections.
- Ensure full traceability and regulatory compliance.
Aligned with Global Regulatory Standards
Compliance at every step.
All microbiology testing is performed in accordance with global regulatory standards to ensure compliance, data integrity, and audit readiness.
European Pharmacopoeia (Ph. Eur.) Compliance
All testing performed in alignment with relevant Ph. Eur. chapters:
- Microbial Limit Testing (MLT): Conducted as per Ph. Eur. 2.6.12 (Microbial Enumeration Tests), 2.6.13 (Test for Specified Microorganisms), and 2.6.31 (Herbal Medicinal Products and Extracts).
- Bacterial Endotoxin Testing (BET): Performed according to Ph. Eur. 2.6.14 using validated Gel-Clot methods.
- Subvisible Particle Testing: Conducted as per Ph. Eur. 2.9.19 (Particulate Contamination: Sub-visible Particles).
- Preservative Efficacy Testing (PET): Performed in line with Ph. Eur. 5.1.3 (Efficacy of Antimicrobial Preservation).
- Microbiology Method Validation (MMV): Executed as per Ph. Eur. 5.1.6 (Alternative Methods for Control of Microbiological Quality) to ensure suitability, validation, and compliance.
- GMP Compliance: Laboratory operations are conducted under Good Manufacturing Practice (GMP), ensuring consistent quality and regulatory control.
- 21 CFR Part 11 Compliance: Electronic data and record systems maintained with traceability, security, and complete audit trails.
- Validated Methods (MMV): All analytical and microbiological methods validated for accuracy, precision, and regulatory suitability.
- Data Integrity: Real-time data capture, controlled documentation, and audit-ready systems in place to ensure transparency and inspection readiness.
- Regulatory Inspection Readiness: Processes and documentation designed to support client audits and regulatory inspections.
Technical Expertise in Microbiology Testing
Built on science. Proven in practice.
Microbiology Method Validation (MMV)
All methods are validated for accuracy, precision, and suitability in line with pharmacopeial and GMP
requirements.
Compendial Compliance
Testing performed according to Ph. Eur. standards for MLT, BET, and Sub-Visible Particulate Matter.
Advanced Instrumentation
Use of calibrated and qualified equipment for precise and reproducible results.
Controlled Laboratory Environment
Environmental monitoring ensures testing is performed in contamination-controlled lab conditions.
Endotoxin Detection (BET)
Gel-Clot methods with sensitivity checks, non-interfering dilution, and recovery validation.
Sub-Visible Particulate Matter Analysis
Detection and measurement of particles ≥10 µm as per Ph. Eur., USP, and GMP standards.
Data Integrity & Traceability
Real-time data capture with full audit trails in 21 CFR Part 11-compliant systems.
Regulatory-Ready Documentation
Audit-ready reports aligned with GMP and global regulatory expectations.
Why Choose Sciom for Microbiology Testing
Trusted testing. Reliable results.
GMP-Compliant Microbiology Testing
Comprehensive support for non-sterile products, preservative systems, and particulate contamination control.
Pharmacopeial Expertise
Strong expertise in Ph. Eur., BP covering TAMC, TYMC, specified microorganisms, Preservative Efficacy Testing (PET), Bacterial Endotoxin Testing (BET), and sub-visible particles.
Regulatory-Ready Reporting
Reports aligned with MHRA, EMA, Ph. Eur., and BP guidelines for smooth batch release and inspection readiness.
Integrated Quality Support
Microbiology testing integrated into product quality and contamination control strategy for faster, data-driven decision-making.
Client-Focused Service
Clear communication, reliable turnaround times, and tailored support across all development stages.
Our Comprehensive CDMO Service
Everything you need. One trusted partner.
Insights & Industry Trends
Stay informed with expert commentary on pharmacovigilance services, regulatory consulting services, analytical science and audit compliance services across the pharmaceutical industry.
