Sterile/Negative Pressure Filling Isolator
Sterile/Negative Pressure Filling Isolator
The sterile/negative pressure filling isolator provides Class A sterile protection for drug filling, capping, and sterile solution filtration of highly toxic or active drugs. It reduces environmental contamination risks and ensures safety in sterile manufacturing.
Key Features:
Modular Design: Flexible structure for matching filtering, filling, dispensing, and capping functions.
Flexible Production: Supports both penicillin bottle and pre-filled needle production lines.
Segment Isolation: Independent segments with leak testing and VHP sterilization.
Pressure Gradient: Airtight segments maintain differential pressures to prevent cross-contamination.
Environmental Monitoring: Integrated particle and airborne microbe sampling system.
Sterile Transfer Ports: Optional RTP barrel/valve systems for secure transfer.
Glove Leak Detection: Wireless system prevents contamination from glove rupture.
CIP/WIP Support: Clean-in-place and wash-in-place for easy cleaning; sloped bottom for effective drainage.
Operational Risk Control: Mock-up confirmation ensures airflow integrity and glove positioning.
Validation Ready: Supports DQ, FAT, IQ, OQ, PQ and related protocols for regulatory compliance.
Applications: Used in pharma production of XDC drugs, oncolytic viruses, and other highly active or toxic compounds.
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