Tests for Specified Microorganisms
Cormica provides tests for specified microorganisms aligned with USP <62>, Ph. Eur and other global pharmacopoeias. These studies confirm the absence of key indicator organisms, so you can demonstrate that your product is safe for its intended route of administration and patient population.
When you release a non sterile product, it is not enough to know that the overall microbial count is under control. Regulators need confidence that certain “objectionable” microorganisms are not present at all.
Our mission is to improve patients’ lives by providing comprehensive testing services that help you launch and release products safely and rapidly across the world. Tests for specified microorganisms are a direct expression of that mission, turning microbiological data into reassurance for both regulators and patients.
Why tests for specified microorganisms matter
Specified microorganism testing helps you to:
- Protect vulnerable patients by confirming that high risk organisms are absent from your product
- Align with regulatory expectations for non sterile products in the US, Europe and other key markets
- Strengthen your contamination control strategy and support product release decisions
- Reduce the risk of costly recalls, complaints or brand damage linked to objectionable organisms
This is about more than ticking a compliance box. It is about being able to say, with confidence, that your product is suitable for the people who rely on it.
What is covered by tests for specified microorganisms?
These tests look for specific indicator or objectionable organisms that are not acceptable for your product type, route of administration and patient group. Typical targets include:
- Escherichia coli as an indicator of faecal contamination
- Staphylococcus aureus and Pseudomonas aeruginosa for cutaneous, nasal, auricular and topical products
- Salmonella for many oral products and raw materials
- Candida albicans and other yeasts for mucosal and vaginal products
- Clostridia for certain high risk products and natural ingredients
These studies are usually performed alongside microbial enumeration (TAMC / TYMC) and microbial limits testing as part of your wider non sterile quality control programme.
Working With Cormica for Microbial Enumeration
Cormica’s tests for specified microorganisms support a wide range of non sterile products, including:
- Oral solid dosage forms such as tablets, capsules and granules
- Oral liquids such as syrups and suspensions
- Topical products including creams, gels, lotions, ointments and transdermal patches
- Mucosal products such as oromucosal, nasal, rectal and vaginal preparations
- Inhalation and respiratory products where indicator organisms are critical to patient safety
- Raw materials and excipients, especially those of natural or higher risk origin
If your risk assessment has identified particular objectionable organisms, we can help tailor a testing strategy that reflects those concerns.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Cormica's Microbiology Testing Services
Non-Sterile Product Quality Control Testing
- Bioburden Testing, Recovery & Validation
- Tests for Specified Microorganisms
- Microbial Enumeration Testing (TAMC/TYMC)
- Preservative Efficacy / Antimicrobial Effectiveness Testing (AET/PET)
- Microbial Limits Testing
- Water Testing (Potable, WFI, Purified)
- Growth Promotion Testing of Media
- Method Suitability / Validation for QC Testing
Endotoxin & Pyrogen Testing
- Bacterial Endotoxins Test (BET) – Limulus Amebocyte Lysate (LAL)
- Kinetic Turbidimetric & chromogenic
- Gel-Clot Method
- Monocyte Activation Test (MAT)
- Recombinant Testing
Other Microbiology Testing Services
- Method Validation & Batch Release Testing
- Disinfectant Efficacy Testing
- Microbial Identification
- (MALDI-ToF, MicroSEQ & VITEK)
- Antibiotic Microbial Assay
- Biological Indicator Enumeration
- Reprocessing Validation
- Cytotoxicity Testing
- R&D Support, Bespoke & Client Specific Testing Protocols
Sterility Testing
- Rapid Sterility Testing
- Celsis Bioluminesence
- Celsis Advance for nonfilterable therapies
Celsis Adapt for Cellular therapies
- Celsis Advance for nonfilterable therapies
- Scan RDI Chemiluminesence
- Celsis Bioluminesence
- Millipore Steritest™
- Particulate Testing
- Container Closure Integrity Testing (CCIT)
- Media Fill Incubation and Analysis
Environmental Monitoring
- Cleanroom Environmental Monitoring Support
- EMPQ and Risk Assessment
- Sampling/Incubation/Enumeration
- Reporting and Trending
- Culture Preservation
- Cleaning Validation Support
- Total Organic Carbon (TOC) Analysis
- Trending, Culture Preservation & Microbial ID
Microbiology Testing Conducted to International Standards Including:
- USP: <51>, <60>, <61>, <62>, <63>, <71>, <85>, <87>, <643>, <645>, <788>, <789>, <1072>, <1116>, <1911>, <643>
- Ph. Eur.: 2.2.44, 2.6.1, 2.6.12, 2.6.13, 2.6.14, 5.1.3, 5.1.6, 5.1.11
- ISO: 10993-4, 10993-5, 11137-2, 11737-1>3,
- ICH / GMP: ICH Q7, EU GMP Annex 15
Our Clients’ Experiences
