Colostrum Quality Assurance

  

APS BioGroup guarantees quality. We follow cGMP (certified Good Manufacturing Practices) and HACCP (Hazard Analysis and Critical Control Procedures) throughout the production process.

Certified Quality Assurance

Quality control in the APS BioGroup lab.

The immunoglobulin type G (IgG) content of colostrum is the traditional measure of its quality and effectiveness. APS tests and certifies the IgG content of its colostrum powders using in-house High Performance Liquid Chromatography (HPLC) units. APS BioGroup also uses one of its three in-house HPLC systems coupled with a Mass Spectrometer to quantify the levels of the important proline-rich polypeptides (PRPs) in each batch.

Analytical Chemistry and Microbiology

All products are sampled and tested using approved AOAC testing methods. Protein, fat, lactose, ash, and moisture are recorded for all products. Tests for other components are performed as required with an in-house Quadrapole Mass Spectrometer.

Aerobic Plate Count (APC or SPC), Coliform bacteria, E. coli, Salmonella spp., Listeria spp., Staphylococcus aureus, Shigella spp., Bacillus cereus, Enterobacteriaceae spp. and Yeast and Mold testing is performed along with other microbiological tests as required.

Environmental testing is preformed on drains and waste water sample points. APS also minimizes waste water by testing biological oxygen demand and chemical oxygen demand.

Clinical Laboratory

APS BioGroup laboratory is registered with the United States federal government as a clinical laboratory. All products are sampled and tested using AOAC or other approved testing methods.

Chemistry Lab Instrumentation

  • Three Waters High Performance Liquid Chromatography (HPLC) Instruments with:
    • Quadropole Mass Spectrometer
    • 2 Variable UV PDAs
    • Refractive Index Detector
  • UV Spectrometer
  • Vacuum Moisture Ovens
  • Moisture Oven
  • Titration Units
  • Sediment Tester
  • Mojonnier Unit
  • Kjehldahl Unit

Microbiology Lab Instrumentation

  • Polymerase Chain Reaction (PCR) Machine
  • Autoclave
  • Beta-Lactams Antibiotic Testing
  • Microscope
  • Colony Counter
  • Inhibitory Substances Tester

R&D Lab Equipment

  • Ion Exchange Systems
  • Semi-Scale Lab Separator
  • Lab Centrifuge

APS Laboratory Staff

Lab manager using APS mass spectrometer

Lab manager using APS mass spectrometer

Quality systems at APS BioGroup are under the direction of Dr. Andrew Keech who has a PhD in biochemistry and considerable dairy processing experience. All four APS BioGroup lab technicians have Bachelor's degrees in Chemistry or Microbiology and we also have a licensed Pharmacist on staff.

Documentation and Process Control

APS BioGroup has over three hundred Standard Operating Procedures that control all aspects of the production process. Every step of manufacturing, material handling, finished goods release, line clearance, employee training and certified Good Manufacturing Practices (cGMPs) are documented. Thirty-two cameras show every movement in the factory. Remote access allows APS Senior Managers to consistently follow all manufacturing process variables.