The Junior is the World's first pharmaceutical Grade A disposable isolator suitable fot filling parenteral products for human use.
The Disposable-Lab Junior is a fully validated pharmacautical isolator that can be set up in Grade D cleanroom (or higher) conditions and is easy to assemble, simply inflate the modules which create the positive overpressue pressure and maintains air quality levels in accordance with Grade A EU GMP (Class 100).
The benefits of using a disposable isolator are as follows:
- reduce investment
- respond quickly to demand
- eliminate pre cleaning measures and after filling cleaning operations for aseptic filling.
The Junior insolator is pre-loaded with everything you need to conduct your fill such as: vials, stoppers, crimp seals, RayDyLyo®, dispensing options, crimping equipment as well as whatever else you need.
It is prepared at Disposable-Lab with the introduction of the components in a sterile manner. This is then deflated and shipped directly to you. The user simply has to inflate the isolator with air (or, if necessary, with nitrogen) and connect the required filling solution to the installed filling line. Filling, capping and capping are manual.
This technology is especially recommended for small scale fills such as Phase I clinical batches, stability batches, toxicology, personalised medications, etc.
The Junior is suitable for fills of up to 1,500 vials (depensing on vial size) and is validated with vials ranging from 2ml and 50ml.
- Perestaltic Pump — product external to the Junior
- Container and Pipette — included inside the Junior
- Disposable-Lab proprietory system
Please Contact Us for more information.