Microbiology
Safeguarding Prescription Drug Quality and Compliance
In the prescription drug industry, microbiological quality is mission-critical. From raw material qualification to finished drug product release, contamination control ensures patient safety, regulatory compliance, and product efficacy. At Q Laboratories, we deliver a comprehensive suite of microbiological testing services tailored to the unique needs of pharmaceutical and prescription drug manufacturers.
Our dedicated microbiology laboratories, combined with on-site technologies such as the Bruker MALDI Biotyper® (MALDI-TOF), provide accurate, rapid, and reliable microbial identification. With all services (microbiology and analytical chemistry) consolidated on a single campus, we eliminate the need to ship samples to multiple labs, streamlining your testing, studies, timelines, and reporting.
Our Capabilities
- Microbial Limits Testing (USP <61>)
- Specified Organism Testing (USP <62>, <60>)
- Antimicrobial Effectiveness Testing (USP <51>, EP, ISO, PCPC)
- Bacterial Endotoxin Testing (USP <85>)
- Microbial Identification (MALDI-TOF Biotyper®)
- Growth Promotion & Suitability Testing
- Validation of Microbial Recovery (USP <1227>)
- Environmental Monitoring (USP <1116>, <797>)
- Water System Validation & Monitoring
- Viable Air Sampling (settle plates, strips, contact plates)
- Surface Swabs
- Cleanroom Monitoring & Validation
- Compressed Air & Gas Testing
- Cleaning Validations
Dedicated Microbial Identification Lab with Cutting-Edge Technology
We utilize the Bruker MALDI Biotyper® (MALDI-TOF) for high-resolution microbial identification. This technology supports international validation efforts, including pathogen confirmation after initial screening.
Our specialized lab provides rapid and accurate organism identification:
- Confirmation of Positive Results
- Identification of House Isolates
- Possible Organism Banking & Long-Term Storage
Explore Test Methodology List
Note: This overview is not exhaustive. For detailed information on client-specific protocols or proprietary Q Labs methodologies, please contact us directly to discuss your specific requirements.
| European Pharmacopeia | C. albicans 2.6.13 | |
| European Pharmacopeia | E. coli 2.6.13 | |
| European Pharmacopeia | Heterotrophic Plate Count [HPC] | |
| European Pharmacopeia | P. aeruginosa 2.6.13 | |
| European Pharmacopeia | S. aureus 2.6.13 | |
| European Pharmacopeia | Salmonella 2.6.13 | |
| European Pharmacopeia | Total Aerobic Microbial Count [TAMC] 2.6.12 | |
| European Pharmacopeia | Total Yeast and Mold Count [TYMC] 2.6.12 | |
| FDA Bacteriological Analytical Manual | B. cereus | |
| FDA Bacteriological Analytical Manual | Coliform | |
| FDA Bacteriological Analytical Manual | Listeria | |
| FDA Bacteriological Analytical Manual | Salmonella | |
| FDA Bacteriological Analytical Manual | Suitability of B. cereus | |
| FDA Bacteriological Analytical Manual | Suitability of Coliform | |
| Gram Stain | Gram Stain | |
| ISO | Detection of C. albicans 18416 | |
| ISO | Detection of E. coli 21150 | |
| ISO | Detection of P. aeruginosa 22717 | |
| ISO | Detection of S. aureus 22718 | |
| ISO | Enumeration and Detection of Aerobic Mesophilic Bacteria 21149 | |
| ISO | Enumeration of Yeast and Mould 16221 | |
| ISO | Preservative Efficacy Testing [PET] 11930:2019 | |
| ISO | Suitability of Detection of C. albicans 18416 | |
| ISO | Suitability of Detection of E. coli 21150 | |
| ISO | Suitability of Detection of P. aeruginosa 22717 | |
| ISO | Suitability of Detection of S. aureus 22718 | |
| ISO | Suitability of Enumeration and Detection of Aerobic Mesophilic Bacteria 21149 | |
| ISO | Suitability of Enumeration of Yeast and Mould 16212 | |
| PCPC | Neutralization [PET] | |
| PCPC | Preservative Efficacy Testing [PET] M-3 | |
| PCPC | Preservative Efficacy Testing [PET] M-5 | |
| PCPC | Preservative Efficacy Testing [PET] M-7 | |
| Q Laboratories SOP | General Enrichment Tests for Qualitative Detection of Aerobic Microorganisms and Fungi | |
| Q Laboratories SOP | Heterotrophic Plate Count [HPC] - Membrane Filtration (TGY) <1231> | |
| Q Laboratories SOP | Heterotrophic Plate Count [HPC] - Pour Plate (TGY) <1231> | |
| Q Laboratories SOP | Microbial/Filamentous Fungi Identification - Bruker MALDI Biotyper | |
| Q Laboratories SOP | Microbiological Examination of Environmental Surface and Air Samples (air settling plate, strip) <1116> | |
| Q Laboratories SOP | Microbiological Examination of Environmental Surface and Air Samples (contact plate) <1116> | |
| SMEWW | Coliform | |
| SMEWW | E. coli | |
| SMEWW | Fecal Coliform | |
| SMEWW | Heterotrophic Plate Count [HPC] | |
| USP | AET Neutralization <51> | |
| USP | Antimicrobial Effectiveness Test [AET] <51> | |
| USP | Antimicrobial Effectiveness Test [AET] with B. cepacia <51> | |
| USP | B. Cepacia Complex <60> | |
| USP | Bacterial Endotoxin - Kinetic Chromogenic <85> | |
| USP | Bacterial Endotoxin Test (Gel Clot) <85> | |
| USP | Bile Tolerant Gram Negative Bacteria <62> | |
| USP | C. albicans <62> | |
| USP | Clostridia <2022> | |
| USP | Clostridia <62> | |
| USP | E. coli <2022> | |
| USP | E. coli <62> | |
| USP | Enterobacterial Count (Bile Tolerant Gram Negative Bacteria) - MPN <2021> | |
| USP | Environmental Monitoring <797> | |
| USP | Growth Promotion <61> | |
| USP | P. aeruginosa <62> | |
| USP | Preparatory Testing <2021> | |
| USP | Preparatory Testing <2022> | |
| USP | Preparatory Testing <85> | |
| USP | S. aureus <2022> | |
| USP | S. aureus <62> | |
| USP | Salmonella <2022> | |
| USP | Salmonella <62> | |
| USP | Suitability of B. cepacia Complex <60> | |
| USP | Suitability of the Counting Method <61> | |
| USP | Suitability of the Test Method <62> | |
| USP | Total Aerobic Microbial Count [TAMC] <2021> | |
| USP | Total Aerobic Microbial Count [TAMC] <61> | |
| USP | Total Yeast and Mold Count [TYMC] <2021> | |
| USP | Total Yeast and Mold Count [TYMC] <61> | |
| USP | Validation of Microbial Recovery <1227> |
