| Assay no | Test | Verbal result within |
|---|
| 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 |
