Pharmaceutical Microbiology Testing

 

Aemtek offers the following microbiology testing of pharmaceutical raw materials and end products:

Sterility Testing

  • Self-contained BI Indicators
  • Spore Strip Immersion
  • Direct Inoculation Method
  • Membrane Filtration Method                                                          

Endotoxin Testing - LAL, Kinetic Chromogenic Method 

Bioburden Testing

  • Pour Plate Method (all bacterial and fungal groups)               
  • Membrane Filtration Method (all bacterial and fungal groups)                                  
Environmental Microbiology Testing
  • Rodac or Settling Plates Count and Identification                                                                     
  • Impact Viable Air Sampler Plates Count and Identification                                                  
  • Bacteria Gram Stain                                                                                          
  • Bacterial Species Identification                                                                                   
  • Fungal Species Identification                                                                           
  • Total Coliform & E. coli, presence/absence/quantification                                                     
  • Water Heterotrophic Plate Count                                                                     
  • Microbial Limits                                 

Aemtek’s exceptional human and technological resources ensure that you receive accurate, comprehensive information to support your environmental monitoring. Our experienced Ph.D. microbiologists and mycologists use the most advanced technologies, including phase-contrast microscopy, real-time PCR, and kinetic analysis for endotoxins.

Aemtek is committed to providing the highest quality of results in a timely manner. Our laboratory employs rigid quality assurance measures and holds multiple accreditations, including AIHA and EMLAP, to ensure that your data is scientifically sound and legally defensible. Reports are electronically generated in user friendly language and formats to aid you in your assessments and decision-making. Our professional staff are ready to answer your questions and address your concerns.