The sterility test is perhaps one of the most critical tests performed by the microbiologist and yet very little of the methodology has changed since its inception. The one area that has changed is the environment in which the test is undertaken
Traditionally, sterility testing has been performed within a laminar flow hood (GMP Grade A), which is sited within a cleanroom (GMP Grade B) but this can lead to false-positive results. These are generally due to contamination caused by the testing environment or technician/technique error and cause additional work in terms of extra documentation. This adds significantly to cost as it delays or prevents the release of the drug product.
Our sterility test isolators provide continuous and complete isolation of the inside of the isolator from the external room environment and with the Rapid Gas Hatch, it can provide continuous batch processing.
- 316L Stainless steel construction
- Main Chamber available as 2,3 or 4 glove
- Ergonomic design
- Integrated VHP-U system – Howorth BioGen
- Rapid gassing hatch
- Integrated sterility test pump
- Grade A (ISO 14644 – 7:2004) uni-directional airflow
- HMI controls with the printing of critical data
- CFR21 part 11 data acquisition available
- Conforms to United States Pharmacopeia (USP) chapter 1208