A Range of Five Modular Isolators for Sterility Testing

Telstar has developed a new range of five modular isolators for sterility testing in the pharmaceutical and biopharmaceutical industry, which can be configured to the number of samples to be processed.

The range of isolators designed by Telstar makes it possible, for the first time, to validate sterile/aseptic production processes by selecting the size of the equipment according to the number of samples to be processed, considering production batch size, process time and space available. By incorporating an optional material air-lock, it is possible to operate the isolator in continuous mode, whereby samples are introduced as required.

Type 1.- 2 gloves are suitable for 1 to 2 Sterility Tests per batch; type 2 - 3 gloves are suitable for 3 to 6 Sterility Tests per batch; type 3.- 4 gloves are suitable for 7 to 10 Sterility Tests per batch; type 4 - 3 gloves with material air lock are suitable for 20 Sterility Tests per batch and continuous processing; and type 5 - 4 gloves with material air lock are suitable for 20 Sterility Tests per batch and continuous processing.

The modular concept and standardisation ensure a testing process which is adaptable to the particular characteristics of each application, with the resulting benefits in cost and energy saving, while also maximising the effectiveness of the process. The difference in the initial investment between a Type 5 and a Type 1 unit can represent a saving of over 30%, as well as saving in operating and maintenance costs.

The new Telstar range of modular isolators for sterility testing incorporates a decontamination system using for the first time ionised hydrogen peroxide (iHP).

This is the only system in the decontamination market which does not require the isolator preconditioning stage, enabling a saving in process time and costs of as much as 10% per cycle compared to the traditional type of H2O2 systems.

Telstar has also developed all the accessories to enable the new range of sterility testing isolators to use any H2O2 decontamination system, either integrated or external to the isolator.