Sterility test isolator for injectables and sterile powders
In the bio-pharmaceutical industry, ensuring sterility of products such as injectable liquids and sterile powders is critical. Any contamination during sterility testing can have significant consequences, necessitating highly reliable and repeatable processes.
Maintains strict sterility standards
The FCTS Sterility Test Isolator by Fedegari is designed to meet the rigorous requirements of sterility testing for pharmaceutical samples, including injectable liquids, ophthalmic ointments, sterile antibiotic powders, and freeze-dried drugs. The isolator incorporates an H2O2 vaporizer system standardized in Fedegari’s bio-decontamination pass-boxes. This system ensures real-time biocide concentration control, with H2O2 sensors maintaining vapor concentration within ± 15 ppm for consistent process repeatability. The FCTS isolator features a non-directional BA surface finish in the working chamber, ultra-safe air-tight doors, and a stainless steel trolley for continuous material transfer. It is compliant with FDA, EMA, WHO guidelines, and various EN standards. The system is modular, allowing for customizable internal storage and placement of pass-boxes and working chambers to meet specific needs.
Benefits
- Reduced operational costs due to non-proprietary consumables.
- High reliability with 100% air-tight doors and real-time process control.
- Cost-effective from drastically reduced validation time.
- Customizable internal spaces for specific load requirements.
- Integration with SCADA and MES systems via Thema4.