INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • 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 Hybrid Isolator designed to provide personnel protection while working with powder substances. Enclosure features include acrylic superstructure, black phenolic base, acrylic viewing panels, hinged door style, BIBO filtration with dual HEPA, top mount fan, vent kit, thimble connection, right and left side pass throughs, Go/No Go Red and Green Signal Light, removable draft shield with 6x 8” oval glove ports, 2x minihelic gauges, LED lighting, iris ports on both sides. LED lighting and Acrylic viewing panels maximize lighting across the workspace.

  • Explore chromatography methods for sample preparation, residual solvent, and impurity analysis, critical steps for Active Pharmaceutical Ingredient (API) quality control.

  • The CCI Test Vessel provides a simple means of preparing samples for container closure integrity testing (CCIT) using the highly-sensitive and non-destructive laser-based headspace analysis technology. When combined with a LIGHTHOUSE FMS Headspace Gas Analyzer, the CCI Test Vessel offers a robust solution for container integrity tests on a wide range of container types and packaging conditions.

  • The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.