Aseptic Processing

Overview

The EnGuard aseptic processing workstations are a series of barrier/isolators that provide ISO Class 5 conditions and containment. These workstations are designed primarily for small volume processes including laboratory sterility testing and clinical trial manufacturing.

EnGuard aseptic processing workstations typically consist of multiple chambers with ergonomic glove port access to areas where operator interaction is required. Multiple chambers allow separation of procedures and effective use of pressure differentials to create directional airflow. One chamber can be used for sanitization of incoming materials either manually or by automated vapor systems. The other chambers can be used for subsequent procedures such as solution preparation, filling, stoppering and capping. These workstations can be designed to accommodate either parenteral or sterile powder operations.

Typical uses

Manual Filling
Automated Filling
Freeze Dryer (lyophilizer)
Solution Preparation
Weighing
Packaging

Standard Features

These workstations operate under either positive or negative pressure that is both monitored and alarmed. The framework of these isolators is constructed of 316L stainless steel. Viewing areas are molded from the best quality engineered plastic and all gasket materials are FDA approved.

Each chamber has an independent air handling system that HEPA filters both incoming and exhausted air. Interior HEPA filter openings are covered by a cleanable membrane that protects the HEPA filter and also serves as a pre-filter. Interior surfaces are smooth and easily cleanable. All ceiling, wall and floor junctures are coved. All welds are ground smooth and meet cGMP cleaning standards. Lighting, when required, is mounted on the exterior of the enclosure. A utility panel manifold is provided for liquid transfers and easy access to required utilities.

Advantages

Custom ergonomic integration of equipment including automated fillers supplied by the users choice of manufacturers.
Completely closed system that protects personnel and product.
Modular design that assures future flexibility.
Significantly lower initial cost.
Significantly lower operating cost.
Increased efficiency, increased safety, and decreased cycle times.
Portable for relocation and storage.
Designed to meet regulatory compliance.
Complete validation packages are available.