Aseptic Fully Automatic Filling Isolator
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- Product Description
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I. Applications
Aseptic filling isolators provide critical safety assurance for aseptic manufacturing in small-scale pilot plants and laboratories, while also protecting production personnel from exposure to hazardous materials. These isolators are suitable for production lines handling vial liquid‑injection filling, aseptic lyophilized‑powder filling, pre‑filled syringes, and other applications. Featuring Class A unidirectional airflow to safeguard products in the core zone, they incorporate an integrated vaporized hydrogen peroxide sterilization system, meeting aseptic requirements with a SAL of ≤10⁻⁶.
II. Characteristics
Isolator structure: buffer chamber + operator chamber (dual‑sided operation) + discharge chamber, with positive pressure. The equipment enclosure is fabricated from SUS316L stainless steel, 3 mm thick, and the glass panels are made of 15 mm tempered glass.
Control System: Utilizes an industrial PC and integrates functions for monitoring differential pressure, temperature and humidity, air velocity, VHP concentration, as well as online particulate matter and microbial contamination. It features unidirectional laminar airflow, complies with Class A standards, and is equipped with audit trail and electronic signature capabilities.
VHP Sterilization: Equipped with an integrated VHP sterilization system, it can meet the sterility requirement of a SAL ≤ 10⁻⁶.
Filling Integration: Depending on process requirements, it can integrate functions such as liquid filling and sealing, aseptic lyophilized powder vial filling and sealing, and K‑type vial and prefillable syringe filling and sealing. The isolator is equipped with a robotic arm or a six-axis robot for handling operations.
Material In/Out: Liquids are connected via sterile SART interfaces, enabling aseptic transfer of RTP materials. The aseptic filling isolator employs the pressure decay method for online leak‑rate monitoring, meeting the data requirements of ISO 10648, ISO 14644, and PDA TR34.
Aseptic filling isolators can be equipped with a WIP system, enabling in-line cleaning of the chamber, pipeline rinsing, and drying.
Select different light sources based on the material’s characteristics.
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