ESCO Compounding Isolator
Streamline® Compounding Isolator (SCI) provides a sterile environment for aseptic preparations. It is factory-configured to operate at positive or negative pressure in a recirculating or total exhaust airflow scheme.
This compounding aseptic/sterile containment isolator (CACI) is designed in compliance with international cGMP standards and classified under Class 3 Leak Tight Containment as per ISO 10648-2.
Positive pressure is intended for handling of sterile non-hazardous materials while negative pressure is for containment of sterile hazardous substances.
The latter is further classified into two, the purposes of which are:
- N1: factory-configured to provide a more negative pressured pass-through chamber (PTC) in accordance with the CETA guideline for testing compounding isolators.
- N2: factory-configured to provide a more negative work chamber than the PTC for powder handling applications.
The SCI Total Exhaust or Single Pass unit is especially designed for the handling of hazardous drugs (HDs), especially those exhibiting volatile components, as they are being compounded in healthcare settings. It is negatively pressured to ensure user, product, and environmental protection against hazardous substances.
Meanwhile, the SCI Recirculating unit is factory-figured to run at either negative or positive pressurization, depending on the client’s needs and application. This can be used for the aseptic handling of non-volatile hazardous (negative model) or nonhazardous substances (positive model). It is designed to provide product, operator, and environmental protection against any form of exposure or cross-contamination.
Key Benefits:
- Complies with the international cGMP standards
- Class 3 pressure tested as per ISO 10648-2
- ISO Class 5 air cleanliness as per ISO 14644-1
- Fast purging time
- Compliant to USP <797> and <800>
Features
- ULPA filters (as per IEST-RP-CC001.3 and HEPA (H14) filter as per EN 1822) with a typical efficiency of >99.999% at 0.1 to 0.3 microns, providing ISO Class 3 air cleanliness as per ISO 14644-1.
- FDA-grade pressure-tight static seals.
- Sentinel™ Gold microprocessor controller supervises all functions and monitors airflow and pressure in real-time.
- Robust dual-wall construction. Unique Esco Dynamic Chamber™ plenum surrounds filter seals with negative pressure.
- Safe-change cuff rings permit glove changes with zero risk of work zone or environment contamination.
Accessories
Standard Accessories
- Electromagnetic interlocking doors to prevent cross-contamination
- Foot switch included to easily open the inner doors
- Single-piece or multi-piece stainless steel 316L work top
- Energy efficient LED lighting with higher durability and better quality
Electrical Outlets and Utility Fittings
- Electrical outlet, ground fault, North America
- Electrical outlet, Euro/Worldwide
Support Stands
- Fixed height, available 711 mm (28") or 864 mm (34") - With levelling feet, ± 38.1 mm (1.5") (SAL) - With casters (SPC)
- Telescoping height stand for levelling feet (STL), nominal range 660 mm to 960 mm (26"to 37.8")
- Telescoping height stand for casters (STC), nominal range 660 mm to 880 mm (26" to 34.6") - Adjustable in 25.4 mm (1") increments
- Infinitely adjustable hydraulic stand with casters elevates to accommodate a sitting or a standing user’s work surface height (SHM)
Support Stands
- A 4-glove port (4G) design is possible by combining two units of 2-glove port (2G) isolators, interconnected by a vertical non-interlocking door; with two pass-through chambers.
- External material of construction:
- Electrogalvanized steel with ISOCIDE™ powder coating
- Stainless steel 304
- Dunk tank
- One dunk tank below the work zone
- Exhaust types
- Double HEPA exhaust filter (BIBO top and non-BIBO bottom)
- Side Exhaust Connection (for TE units)
- *Note: Additional carbon filter is available as an option for all exhaust filter configurations
- IV bar, with hooks
- UV lamp
- Flexible / Thimble exhaust collar
- Side Exhaust Connection (for TE units)
- Hard ducting with Anti-blowback valve
- Perforated shelf to increase work zone space
- Cleaning accessories
- Alarm package
- Laboratory cart
- Adjustable foot rest
- Stainless steel turntable
- Butterfly valve:
- Manual
- Automatic
Add-Ons
- Monitor System
- Mounted on the rear of the isolator
- Beside the front panel; equipped with a keyboard and mouse arm
- Mobile BioVap™ biodecontamination system
- Glove Leak Tester
- Automated pressure hold testing (APHT)
- With on-board compressed air
- with on-board pump (available by 2020)
- CCTV integration
- Back wall
- Front of the visor with a stainless steel mount
- Back-up battery for the electromagnetic interlocks (contact Esco for more information)
- Side-syringe pass-through chamber
