Pharmaceutical Microbiology Testing

AXPATH Biotechnology provides expert microbiology testing services for the pharmaceutical industry, adhering to stringent standards. Contact us to learn how we can support your quality control needs with our rapid and reliable testing solutions.

Pharmaceutical Microbiology Tests

Sterility, Endotoxin & Pyrogen Testing

  1. Sterility Testing (USP <71>)
  2. Bacterial Endotoxin Test (LAL – Gel Clot)
  3. Bacterial Endotoxin Test (LAL – Turbidimetric)
  4. Bacterial Endotoxin Test (LAL – Chromogenic)
  5. Recombinant Factor C (rFC) Endotoxin Test
  6. Pyrogen Test (Rabbit Test – where still applicable)

 

Bioburden & Microbial Enumeration

  1. Bioburden Testing (Pre-Sterilization)
  2. Total Aerobic Microbial Count (TAMC)
  3. Total Yeast and Mold Count (TYMC)
  4. Heterotrophic Plate Count (HPC)
  5. Anaerobic Bioburden Testing
  6. Spore Count Determination

 

Microbial Limits & Specified Organisms

  1. Microbial Limit Testing (MLT) – USP <61>
  2. Specified Microorganism Testing – USP <62>
  3. Escherichia coli Detection
  4. Salmonella spp. Detection
  5. Pseudomonas aeruginosa Detection
  6. Staphylococcus aureus Detection
  7. Candida albicans Detection
  8. Clostridium spp. Detection (as required)
  9. Burkholderia cepacia Complex (BCC) Testing
  10. Objectionable Organism Testing (Product-Specific) 

Environmental Monitoring (EM)

  1. Viable Air Monitoring (Active Air Sampling)
  2. Passive Air Monitoring (Settle Plates)
  3. Surface Monitoring (Contact Plates)
  4. Surface Swab Testing
  5. Personnel Monitoring – Gloves
  6. Personnel Monitoring – Gowns/Sleeves
  7. Non-Viable Particle Monitoring
  8. Environmental Monitoring Trend Analysis
  9. Antibiotics - Potency Testing

Water, Utilities & Facility Systems

  1. Purified Water Microbial Testing
  2. Water for Injection (WFI) Microbial Testing
  3. R2A Low-Nutrient Water Testing
  4. Biofilm Detection Studies
  5. Compressed Gas Microbial Testing
  6. Clean Steam Microbial Testing

Identification, Characterization & Investigation

  1. Microbial Identification (Biochemical / Phenotypic)
  2. Microbial Identification (MALDI-TOF)
  3. Microbial Identification (16S / ITS Sequencing)
  4. Gram Stain & Morphology Analysis
  5. Strain Typing / Genotypic Fingerprinting

 

Validation, Qualification & Process Control

  1. Growth Promotion Testing (GPT)
  2. Method Suitability / Inhibition-Enhancement Testing
  3. Microbiological Method Validation / Verification
  4. Media Fill (Aseptic Process Simulation)
  5. Preservative Effectiveness Testing (AET / PET – USP <51>)
  6. Disinfectant Efficacy Testing
  7. Hold-Time & Clean-Hold Validation (Microbial)
  8. Stability Microbiological Testing (Shelf-Life Support)

 

Regulatory Standards Typically Applied

  • USP <51>, <61>, <62>, <71>, <85>, <1223>
  • FDA cGMP (21 CFR 210/211)
  • EU GMP Annex 1
  • ISO 14644 / 13408

USP and EP Testing Procedures

We specialize in Microbiology Testing Procedures according to the US Pharmacopeia (USP) and the European Pharmacopeia (EP). Ensure your products meet global regulatory requirements with our precise and efficient testing services.

Rapid solutions

Discover how our rapid microbiology testing products can solve critical challenges in the pharmaceutical industry. Email us at AxpathBiotechnology@AOL.Com for pricing and detailed information on how we can assist your specific needs.

Expert consulting

Beyond testing, we offer expert reviews of your test results and provide actionable recommendations. As a trusted consulting group, AXPATH Biotechnology supports your contamination control and manufacturing processes. Contact us anytime, even holidays! Call: 424-319-1138

AXPATH Biotechnology's rapid testing and expert consultation will significantly improved  manufacturing quality. Our 24/7 availability is a game-changer.