Microbiology tests

Assay numberTestVerbal result after
BT 701A

Mycoplasma Assay (Ph. Eur.)

  • Detection of anaerobic and aerobic cultivable Mycoplasmas and non-cultivable Mycoplasmas.
  • Inoculation of indicator cell line for DNA stain.
  • Mycoplasma species identification in case of a positive result.
9 weeks
BT 701B

Mycoplasma Assay non-cellular Material (FDA)

  • Detection of anaerobic and aerobic cultivable Mycoplasmas and non-cultivable Mycoplasmas.
  • Mycoplasma species identification in case of a positive result.
7 weeks
BT 703A

Pyrogenicity Test in Rabbits (Ph. Eur.)

  • Rabbit test in accordance with European Pharmacopoeia.
2 weeks
BT 703B

Pyrogenicity Test in Rabbits (USP)

  • Rabbit test in accordance with USP.
2 weeks
BT 704A

Test for Abnormal Toxicity (Ph. Eur.)

  • Test in guinea-pigs and mice in accordance with European Pharmacopoeia.
3 weeks
BT 704B

General Safety Test (USP)

  • Test in guinea-pigs and mice in accordance with USP/CFR.
3 weeks
BT 705

Sterility Test

  • Sterility test in accordance with USP and European Pharmacopoeia.
2 weeks
BT 706

Bioburden

  • Quantification of the aerobic bioburden in accordance with European Pharmacopoeia.
2 weeks
BT 830

Determination of Endotoxin Content by means of LAL-test

  • Chromogenic assay for the determination of endotoxin content in protein solutions.
2 weeks