Atlas Analytical Inc.

Atlas Analytical is a sister laboratory to FOCUS Laboratories.  Tony cofounded Atlas in 2015 to serve the compounding pharmacy industry specifically and sterile manufacturers generally. 

Following the New England Compounding Center (NECC) tragedy in 2013, the FDA began auditing compounding pharmacies in earnest and publishing its FDA 483 Audit findings.  Reviewing these findings, Tony was surprised by how little quality laboratory support compounding pharmacies had.  He saw a need for an FDA registered cGMP compliant laboratory that utilized validated rapid microbiology technology in an affordable but compliant way.  He started Atlas Analytical to fill this void.

Some of the services offered by Atlas Analytical include:

Scan RDI Rapid Sterility Testing
Automated real time microbial detection and enumeration method.  The system relies on a viability dye with liberates free fluorochrome into the cytoplasm, which is detected by laser scanning of a filter membrane.  The entire test can be completed in less than a day, as compared with the two week Pasteurian USP <71> test commonly employed by the pharmaceutical industry.  The short shelf life of compounded drug products cannot abide a 3 week test.  
Atlas has qualified the equipment and has housed it in a certified clean room to reduce laboratory contamination.  Every formulation must be shown to be suitable for this test, Atlas has a complete library of validated formulations.

Endotoxin:
Atlas has kinetic endotoxin testing capabilities, which allows for enumeration of endotoxin levels in drug products in a few hours.   Atlas can test sterile products, water, medical devices with this system.  Atlas also has a method for qualifying depyrogenation ovens utilizing endotoxin spiked glassware.

Conventional  Microbiology:
Atlas also has a full array of conventional microbiology tests, including but not limited to:

  • USP <51> Antimicrobial Preservative Efficacy
  • USP <61> Nonsterile Product Microbial Enumeration
  • USP <62> Nonsterile Product Test for Specified Microorganisms
  • USP <71> Sterility Test
  • EM Support
  • Media Fill
  • Growth Promotion

Container Closure Integrity:
Atlas can augment your sterility program by confirming your product is impermeable to dye during shipping and handling with an in house CCI Test.

Particle Count:
Atlas can confirm injectable product is compatible with USP <788> Particulate Matter in Injections using a light obscuration method

Stability Studies:
Atlas has chambers for storing product under ICH conditions, to confirm stability of product formulations.

Drug Potency Methods:
Atlas has HPLC, titration, and UV VIS methods to confirm drug potency.

Raw Material Testing:
Atlas has FTIR, UV VIS and wet chemistry capabilities to confirm the identify of raw materials used to compound drug products.

The continued success of Atlas Analytical has required a larger footprint.  The lab has recently relocated to a larger site in Brooksville, FL.  The new site includes a validated clean room, stability chambers, and enhanced chemistry laboratory.  [PRESS RELEASE]