Secure Sampling for Biopharmaceutical Fluids
Realize the Benefits of GORE™ Aseptic Sampling Device
- Single use, pre-assembled and pre-sterilized system
Reduced labor, cleaning costs and validation time
- Connects to standard vessel ports
Works with your existing equipment
- Modular system includes a full range of peripherals
Easy to customize for your specific process
- CIP/SIP-compatible, customized configurations and sample receptacle options
Able to fit any process protocol
- Single and five-shot assembly options
Enables multiple but discrete aseptic sampling from a single-vessel port
- USP Class VI materials and complete engineering and microbial test package
Quick validation and implementation
- Needle-free, linear valve actuation
Safe for operators and fragile cell media
Product Description
GORE™ Aseptic Sampling Device is a single-use, closed sampling system that comes fully assembled, pre-sterilized, and fits most standard vessel ports. A wide variety of customization options are available.
Typical applications include:
- Monitoring cell count and development
- Testing for purity, pH and ingredient concentration
- QC retains and sterile transfers
- Small volume (10 ml) to large volume (1l) options
| Part Numbers |
| Single-valve |
ACS-9060 |
| Five-valve |
ACS-9061 |
Materials of Construction
All USP Class VI and FDA-compliant |
| Valve and housing: |
Polyetherimide (PEI) |
| Gasket: |
Platinum-cured silicone |
| Tubing (choice): |
Platinum-cured silicone
Thermoplastic elastomer (SEBS) |
| Collection container: |
Bag: multi-layer polyethylene film
Bottle: PETG
Syringe: Polypropylene (PP) |
| Dimensions |
| Single-valve |
Fits standard 3/4in TC port |
| Five-valve |
Fits standard 1.5 in port |
Packaging
Vacuum-sealed, double bagged in high-strength 5-mil polyethylene, and labeled for full lot traceability. All products are 100% tested for pressure resistance and visually inspected. Assemblies are typically shipped post-gamma irradiated with an exposure indicator label on the inner packaging.
Pre-sterilization
20 – 35 kGy (standard)
Pressure Rating
Exceeds 40 psi internal and external fluid pressure
Exceeds 15 psi steam at 121° C
Flow Rate
Greater than 15 ml/sec at 0.3 bar
Microbial Ingress/Egress Resistance
As measured by independent lab immersion protocol with B. diminuta culture: no growth after two weeks.
Sample Sealing System
An aseptic sample can be removed from a closed system. A 316L stainless steel separation collar is double crimped and sealed at both sides of the separation, using Gore’s proprietary crimp and cut tool.
Material Properties
| PEI Valve and housing |
| Property |
Test Method |
Specifications |
| Heat deflection temperature at 66 psi |
ASTM D648 |
210° C |
| Izod impact, notched, 23° C |
ASTM D256 |
3 cm-kg/cm |
| Biocompatibility |
USP Class VI and FDA |
Compliant |
| Platinum-cured silicone tubing |
| Property |
Test Method |
Specifications |
| Durometer, Shore A units |
ASTM D2240 |
48-58 |
| Temperature range |
|
-80 to 200°C |
| Biocompatibility |
USP Class VI and FDA |
Compliant |
| Thermoplastic elastomer (SEBS) tubing |
| Property |
Test Method |
Specifications |
| Durometer, Shore A units |
ASTM D2240 |
64 |
| Temperature range |
|
-45 to 135°C |
| Biocompatibility |
USP Class VI and FDA |
Compliant |
| Multilayer PE film bag |
| Property |
Test Method |
Specifications |
| Temperature range |
|
-80 to 60° C |
| Gamma stability |
Suggested maximum |
50 kGy |
| Biocompatibility |
USP Class VI and FDA |
Compliant |
| PETG Bottle |
| Property |
Test Method |
Specifications |
| Heat deflection temperature at 66 psi |
ASTM D648 |
170° C |
| Maximum use temperature |
|
70°C |
| Gamma stability |
Suggested maximum |
50 kGy |
| Biocompatibility |
USP Class VI and FDA |
Compliant |
Customization Options
| Device |
Tubing Type |
Tubing Length |
Separation Collar |
Fittings |
| Single-valve |
Silicone, clear |
12 in |
1.25 in 316L |
Inlet—Barb/barb |
| Five-valve |
Silicone, color-indicated
(red, yellow, blue, gray, black)
Thermoplastic elastomer (SEBS) |
Other |
stainless steel |
Outlet—Barb/F. Luer®,
Alaris Smart Site®, Cap
Outlet—Barb/F. Luer®, Cap
Outlet—Barb/F. Luer®/60cc syringe |
| Receptacles |
Packaging |
Gamma Exposure |
Safety and Convenience Options |
| Bag — 100ml PE |
5 mil PE, 12x12 in, vacuum sealed |
20-35 Kgrad |
Lever-lock collar (replaces shrink wrap) |
| Bag — 50ml PE |
5 mil PE, 18x18 in, vacuum sealed |
|
Platinum-cured silicone NA flanged gasket |
| Bag — 250ml PE |
Lever shrink wraps, PET |
Other |
Vinyl safety caps (for separated ends) |
| Bag — 500ml PE |
| Bottle — 125ml PETG |
| Bottle — other |
| Syringe — 10 ml (PP) |
| Syringe — 60 ml (PP) |
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