Sterility Test Isolator
DESIGN & TECHNICAL FEATURES
• Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
• Air-tightness is 100% guaranteed by ultra-safe doors.
• Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
• Customizable internal storage and racks: can be designed according to customers’ needs.
• FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.
KEY BENEFITS
• Significantly reduced operational costs: Non-proprietary consumables.
• Reliability: Leak testing totally managed by Thema4.
• Easy integration, thought Thema4, with other Fedegari machines and SCADA systems.
• Cost-effectiveness: Drastically reduced validation time for cycle and load.
• 100% air tightness: Silicon inflatable patented gasket on all doors.
• Process control based on direct feedback, instead of estimations.
• Grids and internal spaces that can be customized according to the load.
• RTP Port for loading and unloading activities.
Sterility Test Isolator
Sterility Testing Isolator
These isolators allow operators to perform sterility tests in an aseptic environment and ensure process integrity. The isolator is compatible with VHP decontamination to achieve the desired level of bio-decontamination.
Specifications
• Robustly constructed in SS 316L with Laminar airflow ISO 5 Grade A classification.
• Customizable ergonomics.
• Standard configuration includes one Pass Box (2 Glove Ports) and main chamber (4 Glove Ports), and a glove integrity tester.
Multiple chamber configuration options are available.
• On-demand process equipment and online particle counter integration.
• H2O2 decontamination optional
• Password protection for different authorisation levels.
Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.
Suitable for:
• Injectable liquids.
• Ophthalmic ointments.
• Sterile antibiotic powders.
• Freeze-dried drugs.
When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.
FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.
This innovative design provides real time biocide concentration control (over traditional estimated calculations).
Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence.
The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.