RealTop Disposable Sampling System
sampling is essential in every pharmaceutical process. Inaccurate or false positive results can not only lead to process interruption, material liquid isolation, but alsoneed to repeat the analysis. With RealTop sterile sampling system, contamination is no longer a threat. RealTop sterile sampling system is a pre-sterilized, closed liquidvolume sampling system. The closed design ensures that your sample is isolated from the point of sampling to the point of analysis, reducing the loss of valuable products. Sampling deviceEnsure optimum performance and eliminate process and sample contamination. Multiple options allow you to customize the sampling components to suit your application.
Typical Applications
|
During the cell culture process, total cell density, survival rate and metabolic parameters are monitored. |
Sampling applications requiring lower affinity for proteins, complex carbohydrates, or small molecules |
| Purity and Component Concentration Sampling | pH analysis |
| Sterility Test | chemical analysis |
|
Bioburden Detection |
endotoxin test |
parameters
01 Standard Sampling Unit
Conventional sampling bag
| Material Description | |
| sampling needle | silicone cap: medical grade platinum cured silicone Handle: Polypropylene Needle tube: 316L stainless steel/washer: stainless steel |
| sampling unit | PuRobust membrane material |
| liquid contact layer | ULDPE |
| Fitting | LDPE boat joint |
| Line | Silicone |
| luer connector | PP |
| Heparin Cap | Polycarbonate/Polyisoprene |
| Multi-port conjoined valve | Polyethylene |
| Specifications | |
| volume/ml | sampling bag specification/length X width/mm |
| 50 | 140 x 80mm |
| 100 | 150 x 90mm |
| 250 | 180 x 130mm |
| 1000 | 310 x 150mm |
| use environment | |
| sampling withstand maximum pressure * | 250ml and below: 0.5bar/1000ml and multiple sampling: 0.3bar |
| working temperature | ‒ 80 to 50°C (protective cover required when the temperature is below freezing) |
| Sampling needle SIP temperature | ≤135°C (2.05 bar, 1h) |
| high pressure sterilization | cannot be autoclaved |
| USP Class VI | All parts in contact with the sampling fluid comply with USP Class VI |
| integrity testing | All units are integrity tested during manufacturing |
| Assembly | Assembly connection in Class C environment |
| sterilization | sampling unit at 25-40kGy |
| bacterial endotoxin | The endotoxin content of each device in the water extract is <2.15EU according to the Limulus Reagent (LAL) test. |
| packaging | Each sampling unit is packed in a double bag |
high pressure sterilization bag
| Material Description | |
| sampling needle | silicone cap: medical grade platinum cured silicone Handle: Polypropylene Needle tube: 316L stainless steel/washer: stainless steel |
| sampling unit | PP membrane material |
| liquid contact layer | PP |
| Fitting | PP boat joint |
| Line | Silicone |
| luer connector | PP |
| Heparin Cap | Polycarbonate/Polyisoprene |
| Multi-port conjoined valve | Polyethylene |
| Specifications | |
| volume/ml | sampling bag specification/length X width/mm |
| 50 | 140 x 80mm |
| 100 | 150 x 90mm |
| 250 | 180 x 130mm |
| 1000 | 310 x 150mm |
| use environment | |
| sampling withstand maximum pressure * | 250ml and below: 0.5bar/1000ml and multiple sampling: 0.3bar |
| working temperature | ‒ 80 to 50°C (protective cover required when the temperature is below freezing) |
| Sampling needle SIP temperature | ≤135°C (2.05 bar, 1h) |
| high pressure sterilization | can be autoclaved |
| USP Class VI | All parts in contact with the sampling fluid comply with USP Class VI |
| integrity testing | All units are integrity tested during manufacturing |
| Assembly | Assembly connection in Class C environment |
| sterilization | sampling unit at 25-40kGy |
| bacterial endotoxin | The endotoxin content of each device in the water extract is <2.15EU according to the Limulus Reagent (LAL) test. |
| packaging | Each sampling unit is packed in a double bag |
sampling bottle
| Material Description | |
| sampling needle | silicone cap: medical grade platinum cured silicone Handle: Polypropylene Needle tube: 316L stainless steel/washer: stainless steel |
| sampling unit | PET bottle |
| liquid contact layer | PET |
| Fitting | HDPE bottle cap |
| Line | Silicone |
| luer connector | PP |
| air filter | PTFE/PP |
| Multi-port conjoined valve | Polyethylene |
| use environment | |
| sampling withstand maximum pressure * | Single unit: 0.50 bar/multiple sampling unit (including waste liquid bag): 0.30 bar |
| working temperature | -80 to 50°C (vertical freezing of sampling bottles. Do not fill more than 80% FS) |
| Sampling needle SIP temperature | ≤135°C (2.05 bar, 1h) |
| high pressure sterilization | cannot be autoclaved |
| USP Class VI | All parts in contact with the sampling fluid comply with USP Class VI |
| Assembly | Assembly connection in Class C environment |
| sterilization | sampling unit at 25-40kGy |
| bacterial endotoxin | The endotoxin content of each device in the water extract is <2.15EU according to the Limulus Reagent (LAL) test. |
| packaging | Each sampling unit is packed in a double bag |
02 Sampling Base
single hole
| Material Description | |
| base | 316L SS |
| dial | PA |
| Lock nut | 304 SS |
| use environment | |
| docking interface | TC 25 |
| surface treatment | wetted part electropolishing Ra≤ 0.6 μm |
| design temperature, base | -80 to 150 ℃ |
| design pressure, foundation | 6.00 bar |
| traceability | complete lot traceability information marked on each base |
| packaging | base is pre-assembled and packaged in a closed box to reduce exposure |
double hole
| Material Description | |
| base | 316L SS |
| dial | PA |
| Lock nut | 304 SS |
| O-ring | EPDM |
| use environment | |
| docking interface | φ25mm Ingold |
| surface treatment | wetted part electropolishing Ra≤ 0.6 μm |
| design temperature, base | -80 to 150 ℃ |
| design pressure, foundation | 6.00 bar |
| traceability | complete lot traceability information marked on each base |
| packaging | base is pre-assembled and packaged in a closed box to reduce exposure |
five holes
| Material Description | |
| base | 316L SS |
| dial | PA |
| limit ring | PA |
| Lock nut | 304 SS |
| Wrench | 304 SS |
| use environment | |
| docking interface | TC50 |
| surface treatment | wetted part electropolishing Ra≤ 0.6 μm |
| design temperature, base | -80 to 150 ℃ |
| design pressure, foundation | 6.00 bar |
| traceability | complete lot traceability information marked on each base |
| packaging | base is pre-assembled and packaged in a closed box to reduce exposure |
03 Disconnecting pliers
| Material Description | |
| Clamp Body | Aluminum |
| lower cutter head | Special steel with hardened special surface treatment |
| upper cutter head | Special steel with hardened special surface treatment |
| screws and bearings | stainless steel |
Ordering Information
01 Standard Sampling Unit
Conventional sampling bag
| sample volume (ml) | Sampling Unit | Quantity/Package | export | Item No. |
| 50mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP050MLIG50/SMP050MLNG50 |
| 100mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP100MLIG50/SMP100MLNG50 |
| 250mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP250MLIG50/SMP250MLNG50 |
| 1000mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP01KMLIG50/SMP01KMLNG50 |
| 3X50mL | Triple | 20 | Heparin Cap/Needle-free Sampling Valve | SMP3B050MLIG/SMP3B050MLNG |
| 5X50mL | quintet | 20 | Heparin Cap/Needle-free Sampling Valve | SMP5B050MLIG/SMP5B050MLNG |
| 3X100mL | Triple | 20 | Heparin Cap/Needle-free Sampling Valve | SMP3B100MLIG/SMP3B100MLNG |
| 5X100mL | quintet | 20 | Heparin Cap/Needle-free Sampling Valve | SMP5B100MLIG/SMP5B100MLNG |
| 3X250mL | Triple | 20 | Heparin Cap/Needle-free Sampling Valve | SMP3B250MLIG/SMP3B250MLNG |
| 5X250mL | quintet | 20 | Heparin Cap/Needle-free Sampling Valve | SMP5B250MLIG/SMP5B250MLNG |
| / | sampling tube | 100 | Heparin Cap/Needle-free Sampling Valve | SMP000MLIG100/SMP000MLNG100 |
high pressure sterilization bag
| sample volume (ml) | Sampling Unit | Quantity/Package | export | Item No. |
| 50mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP050MLIG50PP/SMP050MLNG50PP |
| 100mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP100MLIG50PP/SMP100MLNG50PP |
| 250mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP250MLIG50PP/SMP250MLNG50PP |
| 1000mL | single | 50 | Heparin Cap/Needle-free Sampling Valve | SMP01KMLIG50PP/SMP01KMLNG50PP |
sampling bottle
| sample volume (ml) | Sampling Unit | Quantity/Package | export | Item No. |
| 125mL | single | 25 | exhaust filter | SMB125MLVG25 |
| 250mL | single | 20 | exhaust filter | SMB250MLVG20 |
| 500mL | single | 12 | exhaust filter | SMB500MLVG12 |
| 1000mL | single | 10 | exhaust filter | SMB01KMLVG10 |
| 3X125mL | Triple | 4 | exhaust filter | SMB3B125MLVG |
| 5X125mL | quintet | 4 | exhaust filter | SMB5B125MLVG |
| 3X250mL | Triple | 3 | exhaust filter | SMB3B250MLVG |
| 5X250mL | quintet | 3 | exhaust filter | SMB5B250MLVG |
Product Picture
02 Accessories
| Name | Quantity/Package | Item No. |
| Sampling Base (TC25 Single Hole) | 1 | SMPHLDTC25 |
| Sampling Base (& phi;25 Double Holes) | 1 | SMPHLDINGD |
| Sampling Base (TC50 Five Holes) | 1 | SMPHLD |
| Manual sterile disconnect forceps | 1 | CRIMPT1 |
| Manual Sterile Disconnect Tool Spare Parts Set | 1 | CRIMPTK |
| Blind plugging | 100 | PORTPLG |
Product Picture
