INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • Applied Biosystems genetic analyzer, model 3500, integrated autosampler, 120 volts, serial# 24158-161.

  • As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.

  • API Process Development System designed to provide personnel and product protection while working with powder and liquid substances. Designed to house a Mettler Toledo Easy Max 102, Vacuum Oven, and IKA LR 1000.

  • Downflow Booth for Freeze Dryer/Lyophilizer designed for product protection when conducting vial-filling and loading vialed product into a freeze-dryer. Features a 304 stainless steel alloy superstructure and perforated stainless steel base.

  • Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.