Operator Protection
Product Protection
Environmental Protection
Clean Air
Streamline® Closed Restricted Access Barrier System (SLC-RABS)
The Streamline® Closed Restricted Access Barrier System (SLC-RABS) provides a safe and clean environment for the preparation of sterile non-hazardous drugs in compliance to the United States Pharmacopeia General Chapter <797>.
Closed Restricted Access Barrier System (cRABS) provides a full unidirectional airflow scheme for an ISO Class 5 environment for aseptic processing. SLC-RABS is designed with a rigid wall enclosure and glove port access for process manipulation; this prevents the risk of cross-contamination. The interior of the enclosure is manually sanitised with process components introduced via pass-through chambers.
As such, cRABS provide superior sterility as compared to open front clean air devices (laminar flow clean benches and Class II biological safety cabinets). These systems are a safe and efficient solution for the production of low-volume pharmaceuticals as well as with practices concerning:
Operator aseptic technique training
Expiration settings
Product quality maintenance (once CSP leaves the pharmacy)
Furthermore, cRABS can reduce operating and renovation costs by taking up less space than a traditional cleanroom facility.
- ULPA filters (as per IEST-RP-CC001.3 and HEPA (H14) filter as per EN 1822) with a typical efficiency of >99.995% at 0.1 to 0.3 microns, providing ISO Class 5 air cleanliness as per ISO 14644-1.
- Sentinel™ Gold Microprocessor controller supervises all functions and monitors airflow and pressures in real-time.
- For negatively pressured RABS, the work zone and pass-through chambers are under negative pressure to the room to maintain operator protection in the event of a breach in the system.
- Positively pressured configurations are under positive pressure to the room to ensure product protection.
- Robust dual-wall construction. The work zone is surrounded by negative pressure plenums at the sides and back. Unique Esco Dynamic Chamber™ plenum surrounds filter seals with negative pressure.
- Ergonomically angled front and oval gloveports improve reach and comfort.
- Safe-change cuff rings permit glove changing with zero risk of contaminating the work zone and/or pharmacy environment.
- Easy to clean one-piece work zone liner.
- Esco antimicrobial coating on all painted surfaces to minimize contamination.
- Sharps disposal system and hydraulic height adjustable stand are available as options.
Recirculating Airflow
- Ambient air is pulled through the inlet pre-filter and main filter located on top of the isolator.
- The downflow filter creates a laminar air flow providing ISO Class 5 air cleanliness (ISO 14644-1) to the main chamber and pass-through, with a down flow velocity of 0.30 m/s +/- 20%.
- Air from the work zone and pass-through is quickly purged out by the exhaust fan to keep the area clean. The fan pulls approximately 70% of the purged air back to the plenum, passes through the HEPA downflow filter again, and is recirculated back to the work zone and pass-through.
- Approximately 30% of the purged air is exhausted through the filter to prevent heat build-up inside the isolator.
- Exhausted air is replenished by ambient air coming from the top inlet prefilter that has 80% efficiency.
|
Streamline® Closed - Restricted Access Barrier System |
|||||||||||
|
SLC-RABS-4CN3-S |
|||||||||||
|
Unit |
Model |
Nominal Width |
Glove Port Design |
Pressure Scheme |
Electrical Code |
Sharps Provision |
|||||
|
Streamline® Closed - Restricted Access Barrier System |
SLC-RABS |
4 |
4 ft (1.2 m) |
C |
Circular glove port (300 mm x 300 mm) |
N |
Negative |
1 |
220-240 V, AC, 50 Hz, 1Ø |
0 |
No |
|
2 |
110-120 V, AC, 50 Hz, 1Ø |
||||||||||
|
6 |
6 ft (1.8 m ) |
O |
Oval glove port (200 mm x 300 mm) |
P |
Positive |
S |
Yes |
||||
|
3 |
220-240 V, AC, 60 Hz, 1Ø |
||||||||||
*Please note: Customer can also opt to choose a circular glove port, but if not indicated in the Purchase Order, the default is a standard oval glove port.
|
SLC-RABS-4N-_- |
SLC-RABS-4P-_- |
SLC-RABS-6N-_- |
SLC-RABS-6P-_- |
||
|
Nominal Size |
1.2 meters (4’) |
1.8 meters (6’) |
|||
|
External Dimensions |
Witout Base Stand |
1340 x 820 x 1320 mm (52.8” x 32.3” x 51.9”) |
1950 x 820 x 1320 mm (76.8” x 32.3” x 51.9”) |
||
|
With Base Stand (Min) |
1522 x 820 x 1995 mm (59.9” x 32.3” x 78.5”) |
2132 x 820 x 1995 mm (83.9” x 32.3” x 78.5”) |
|||
|
With Base Stand (Max) |
1522 x 820 x 2250 (59.9” x 32.3” x 88.6”) |
2132 x 820 x 2250 mm (83.9” x 32.3” x 88.6”) |
|||
|
Main Chamber Work Zone (W x D x H) |
840 x 610 x 670 mm (33.1” x 24.0” x 26.4”) |
1450 x 610 x 670 mm (57.1” x 24.0” x 26.4”) |
|||
|
Pass Through (W x D x H) |
355 x 610 x 670 mm (13.9” x 24.0” x 26.4”) |
355 x 610 x 670 mm (13.9” x 24.0” x 26.4”) |
|||
|
Work Zone and Interchange Chamber Performance |
ISO Class 5 (Class 1, Federal Standard 209E) |
||||
|
Inlet Filter Type |
80% efficienct pre-filters |
||||
|
Downflow and Exhaust Filter Type |
HEPA filter with integral metal guards and filter frame gaskets; fully compliant with EN 1822 (H14) and IEST-RP-CC001.3 requirements (each cabinet has individual downflow, exhaust filters and inlet filters). |
||||
|
Typical Filter Efficiency |
>99.995% for particle size between 0.1 to 0.3 micron |
||||
|
Fluorescent Lamp Intensity |
> 950 Lux (>88 foot candles) |
||||
|
RABS Construction |
Main Body |
1.2 mm (0.05”) 18 gauge electro-galvanized steel with white oven-baked epoxy-polyester antimicrobial powder-coated finish |
|||
|
Work Tray |
1.5 mm (0.06”) 16 gauge stainless steel, type 304, with 4B finish |
||||
|
Side Walls |
1.2 mm (0.05”) 18 gauge stainless steel, type 304, with 4B finish |
||||
|
Electrical |
220-240V, AC, 50Hz, 1Ø |
SLC-RABS-4N1-_ |
SLC-RABS-4P1-_ |
SLC-RABS-6N1-_ |
SLC-RABS-6P1-_ |
|
Cabinet Full Load Amps (FLA) |
2.1 A |
2 A |
2.5 A |
2 A |
|
|
Optional Outlets FLA |
5 A |
5 A |
5 A |
5 A |
|
|
Cabinet Nominal Power |
295 W |
301 W |
440 W |
345 W |
|
|
Cabinet BTU |
1007 |
1027 |
1501 |
1177 |
|
|
110-120V, AC, 60Hz, 1Ø |
SLC-RABS-4N2-_ |
SLC-RABS-4P2-_ |
SLC-RABS-6N2-_ |
SLC-RABS-6P2-_ |
|
|
Cabinet Full Load Amps (FLA) |
6 A |
4 A |
8.2 A |
7 A |
|
|
Optional Outlets FLA |
5 A |
5 A |
5 A |
5 A |
|
|
Cabinet Nominal Power |
410 W |
264 W |
600 W |
456 W |
|
|
Cabinet BTU |
1399 |
901 |
2047 |
1556 |
|
|
220-240V, AC, 60Hz, 1Ø |
SLC-RABS-4N3-_ |
SLC-RABS-4P3-_ |
SLC-RABS-6N3-_ |
SLC-RABS-6P3-_ |
|
|
Cabinet Full Load Amps (FLA) |
2.1 A |
2 A |
2.5 A |
2 A |
|
|
Optional Outlets FLA |
5 A |
5 A |
5 A |
5 A |
|
| Cabinet Nominal Power | 295 W | 301 W | 440 W | 345 W | |
|
Cabinet BTU |
1007 |
1027 |
1501 |
1177 |
|
|
Shipping Dimensions, Maximum (W x D x H) |
1590 x 990 x 2210 mm (62.6” x 39.0” x 87.0”) |
2150 x 950 x 2210 (84.6” x 37.4” x 87.0”) |
|||
|
Shipping Volume, Maximum* |
3.48 m³ (122.9 cu.ft) |
4.51 m³ (159.3 cu.ft) |
|||
|
* SLC-RABS only; excludes optional stand. ** Cabinet and GFCI outlet operate on a single power cord. |
|||||
Standard Accessories
Airlock pass-through
Vertical pass-through door
Horizontal tray for easy material transfer
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-_ _ 0) - With casters (SPC-_ _0)
Telescoping height stand for levelling feet (STL-_ _0), nominal range 660 mm to 960 mm (26"to 37.8")
Telescoping height stand for casters (STC-_ _0), 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-_A0)
Options
Electrical outlets
-
UV lamp
*Note: Clearly indicate in PO as UV lamp for SLC-RABS is factory-installed. Sharps disposal system
Alarm package
Exhaust carbon filter
Thimble exhaust collar
Perforated shelf to increase work zone space
*Note: This option is available for customized units.
- Solenoid valve
- IV Bar with Hooks
- Manual volumetric damper
- Service fixture
- European Style
- American Style
*Note: This option is available for customized units.
Be SAFE in Handling High Potency APIs
A significant proportion of new drugs under development contain high potency active pharmaceutical ingredients (HPAPIs). The market of HPAPIs is increasing, with expected growth in the global arena...
