GMP Biopharmaceuticals

Equipment and devices

  • Modular clean room facility approx. 180 m² clean room area, classified according to EU GMP Guidelines, Annex 1 (clean room classes A, B, C, D)
  • Permanent monitoring of the clean room system via a pharmaceutical monitoring system
  • Production rooms allow the processing of various process steps (upstream / downstream / bulk / bottling) due to the different cleanroom classes

Qualified equipment for production

  • CO2 incubators with integrated rotary shaker
  • Positive pressure isolator
  • Bioreactors BIOSTAT® RM20|50 and BIOSTAT® STR200
  • Various liquid handling devices for media production, upstream and downstream:
    • FlexAct® COM
    • BioWelder® Total Containment for sterile tube welding
    • BioSealer® for sterile tubing separation
    • Various pumps (pinch, diaphragm pumps)
  • Cleanroom-class transfer ports Biosafe® 110 Monolever Port
  • Chromatography unit ÄKTA™ pilot
  • Ultra- / Diafiltration unit SARTOFLOW® Advanced
  • Semiautomatic filling line (formats: 5 ml, 10 ml, 20 ml)

Qualified equipment for quality control

  • NucleoCounter® NC-200 ™ for automatic cell count and viability determination
  • ELISA reader Tecan Infinite M1000 PRO
  • NanoDrop 2000
  • Test device according to the specifications of Ph. Eur. 2.9.20 for the test for particle contamination (visible particles)
  • Refrigerators and freezers as well as incubators with temperature recording and monitoring via a monitoring system
  • Leak tester according to Ph. Eur. chapter 3.2.9