Class II isolator NEXT
asepticdispensingfor radiopharmacy

Class II isolator - NEXT - Tema Sinergie - aseptic / dispensing / for radiopharmacy
Class II isolator - NEXT - Tema Sinergie - aseptic / dispensing / for radiopharmacy
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Characteristics

Class
class II
Applications
aseptic, dispensing, for radiopharmacy
ISO class
ISO class 5
Configuration
floor-standing, compact
Other characteristics
vertical laminar flow, shielded

Description

A Class A – ISO 5 unshielded pharmacautical isolator with a lateral Class B – ISO 6 pre-chamber for introduction of clean materials. A very precise ad compact self-shielded integrated dispenser for vials and syringes. SAFETY NEXT minimizes the amount of radiation dose absorbed by the operator. It guarantees the sterility of the dispensed doses. LIGHT & GREEN A new shielding solution makes NEXT the lightest ever and the easiest to install. No more floor load capacity issues. FLEXIBILITY Vials and/or syringes can be dispensed within the same batch of production. No change of disposables is required. Multiple batches are managed with no limitations. DATA PROTECTION Fully FDA 21 CFR part. 11 compliant, to grant traceability and uncorruptibility on operative production data. OVER THE AIR Always online for the remote assistance via VPN connection. KEY FEATURES Class B pre-chamber with turbulent flow Robotic arm with built-in pliers for both vials and syringes Built-in dose calibrators Dispensing filter integrity testing 2 shielded compartments for liquid and solid waste Delivery system for vials and syringes 1 video camera Built-in dose rate meter 1 single batch kit with 0,22 µm filter Software GAMP5 and FDA 21 CFR part. 11 compliant

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