Comecer's Dispensing Isolator provides a robust and adaptable containment solution, ensuring total safety for the user while preserving the purity of the most sensitive pharmaceutical substances.
Dispensing Isolator – Comecer
The Dispensing Isolator by Comecer is a rigid barrier containment system designed for the weighing and dispensing operations of Highly Potent Active Pharmaceutical Ingredients (HAPIs). This device ensures optimal protection for the operator (achieving extremely low OEL levels) and the environment, while maintaining the integrity of the handled product. Thanks to its ergonomic and modular design, it transforms complex powder handling into secure and reproducible processes, in compliance with strict Good Manufacturing Practice (cGMP) requirements.
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The isolator is typically constructed from AISI 316L stainless steel with polished surface finishes to minimize particle retention. It primarily operates under negative pressure to ensure the containment of powders within the work zone. The ventilation system is equipped with high-efficiency HEPA (H14) filters for both air supply and exhaust, often featuring a secure “Bag-in/Bag-out” change configuration.
The equipment integrates advanced features for process management:
- Weighing Systems: Integration of high-precision scales connected to data management systems.
- Cleaning and Decontamination: Equipped with spray guns and WIP (Wash-In-Place) systems for effective cleaning between batches, as well as compatibility with VPHP sterilization.
- Secure Transfer: Utilization of Rapid Transfer Ports (RTP) or alpha/beta valve systems for the introduction of raw materials and the removal of weighed products without breaking containment.
- Automated Control: Managed via a PLC with a touch-screen interface (HMI) for continuous monitoring of pressure, air velocity, and filter status.
This dispensing isolator is essential for the following activities:
- Precision weighing of API powders (Active Pharmaceutical Ingredients) classified as OEB 4 or OEB 5.
- Fractionation of raw materials from large containers into smaller dosing units.
- Support for formulation processes requiring a controlled environment to prevent cross-contamination.
- Handling of toxic or allergenic substances in research or industrial production settings.
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Dispensing Isolator – Comecer
The Dispensing Isolator by Comecer is a rigid barrier containment system designed for the weighing and dispensing operations of Highly Potent Active Pharmaceutical Ingredients (HAPIs). This device ensures optimal protection for the operator (achieving extremely low OEL levels) and the environment, while maintaining the integrity of the handled product. Thanks to its ergonomic and modular design, it transforms complex powder handling into secure and reproducible processes, in compliance with strict Good Manufacturing Practice (cGMP) requirements.
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