Due to increasing market demand Steriline has developed a new range of Stand Alone Isolators for the following applications:
- Quality Control
- Sterility Testing
Additionally, our Stand-Alone Isolators are designed
to work with sterile products either toxic or not-toxic, granting the highest safety level for product and operator.
Also, AISI316L stainless steel walls with high level surface finishing grant ease of cleaning and sanitization.
Further, the isolator maintains an ISO 5 environment using unidirectional or turbulent air flow. Moreover, the isolator is equipped with fans and HEPA filters to supply sterile air. Also, HEPA filters allow easy access for maintenance.
RTP ports enable In-Out product and waste transfer without safety or sterility failure.
In addition, the cycle automation is achieved through the synoptic HMI for production phase, decontamination phase, aeration, integrity test and maintenance. Likewise, mock-up studies and tests allow perfect accessibility of the operator to all isolator functions.
Equally important, the integrated control system comprises a PLC and touch screen operation panel for easy operator interface (HMI).
Lastly all Steriline systems are in compliance with cGMP, GAMP and 21CFR Part11 requirements.