TakeOne® Aseptic Sampling System
Quick, Accurate, Reliable and Safe
Aseptic sampling devices are a critical component in an effective microbial control program. Samples collected with TakeOne® are used to measure critical purity attributes such as bioburden, sterility and endotoxin levels and important process parameters like metabolites, nutrients, osmolality, pH and more. The TakeOne® aseptic sampling device is a pre-assembled and single-use sampling solution. The 1,5" or 2" device has 5 or 9 fully-closed and independent sampling lines. TakeOne® collects perfectly representative samples giving exact results with no risk of false positives.
- Closed and Aseptic Sampling
- Perfectly Representative Samples
- Pre-assembled and Ready-to-use
- On Demand Sample Collection
- Operator-friendly Ergonomic Design
- Fully Single-use and Disposable
Reduce Waste and Eliminate False Positives
Each fluid pathway is fully closed and aseptic from the process vessel to sample container so there is no risk of false positives or ambiguous results. The spring return actuator helps operators to reduce product waste or burst sampling lines from over sampling.
Point of Use Configuration
Some sampling plans are unscripted or highly variable. TakeOne® sampling lines are available with weldable TPE tubings such as C-Flex®* or with aseptic connectors allowing for point of use configuration. Weld on or aseptically connect a collection vessel at the point of use for highest degree of flexibility and adaptability.
*C-Flex® is a registered trademark of Saint-Gobain Performance Plastics Corporation.
Cell Culture | Cell Harvest
Bioburden Monitoring for non-host organisms to ensure axenic culture Process monitoring in support of cell growth
Purification | Virus Removal | Inactivation
Bioburden & Endotoxin Monitoring prior to and at conclusion of process steps including; depth filtration, centrifugation, chromatography & UF | DF
Process Monitoring for correct balance & concentrations Bioburden Monitoring for sterility check
Formulation | Fill & Finish
Bioburden & Endotoxin Monitoring prior to formulation and fill | finish steps to ensure levels are within regulatory limits
Patented Technology for Aseptic Sample Collection
Patented technology isolates each sampling line and ensures the fluid pathway and vessel the device remain aseptically sealed even after dozens of actuations.
Cross-Section of TakeOne®, Before and After Actuation
Cross-Section of TakeOne®, During Actuation
Built and Validated for Reliable Performance
TakeOne® Validation Summary
|Irradiation | Sterilization Validation||Gamma, 25kGy to 35kGy, per ISO11137-2|
|Assembly | Manufacturing Space||ISO 7|
|Biocompatibility||Passes USP Class VI|
|Bacterial Endotoxin||Passes USP 85 (<0.125 EU/mL)|
|Particulate Test||Particulate Test Passes USP 788 |
(≤ 3 particles/ml >25μm; ≤ 10 particles/mL >10μm)
100% Leak Tested
We take seriously the trust you put in us to deliver a high-performing device for critical operations. Every sampling line on every TakeOne® is leak-tested before release.
Soft Parts Life Cycle
Soft Parts, also known as reusable parts, are components used on multiple batches in a production process. Reuseable parts present a risk of bioburden contamination which can be due to improper cleaning, improper assembly, damaged or worn parts and other reasons.
Regulatory Agencies demand a risk assessment on all equipment including validation of the number of uses, number of cleaning | sanitization cycles and a program to monitor and control the life cycle of equipment before replacement.
Security in Simplicity
The TakeOne® is the first Pre-Assembled Aseptic Sampling device and is fully single-use. The inherent simplicity of the TakeOne® removes risks of other sampling systems with complex life-cycles. Production processes with TakeOne® are clean, simple and robust.
The pre-assembled and single-use TakeOne® eliminates risk, reduces costs and saves time. TakeOne® is the preferred aseptic sampling device for an effective microbial control and monitoring program.
How to sample with TakeOne®
Step 1 - Receive
Step 2 - Install
Step 3 - Sample
Step 4 - Disconnect
Step 5 - Remove
Step 6 - Safely Dispose
No Assembly, No Disassembly
Avoid risk of repetitive-use hand injury and protect operators from handling sharp.
It´s About Time
Robust Materials of Construction
Thoughtfully selected materials ensure the device meets the most rigorous of process conditions.
|Tank Mount||316L Stainless Steel, electropolished, 15rA or better|
|Cannula | Needle||316L Stainless Steel, electropolished, 15rA or better|
|TakeOne® Body||High temperature glass reinforced polyester|
|Autoclave||Yes, 122°C for 30min (configuration dependent)|
|Max Steam-in-Place Sterilization||60 min at 30psig|2bar|134.5°C, up to 10 times after actuation|
|Min/Max Temperature||-55°C/300°C (configuration dependent)|
|Operating Temperature Range||-20°C to 50°C (configuration dependent)|
|Burst Pressure (Takeone Mount)||8.9 bar (129psi)|
|Maximum Operating Pressure (Takeone Mount)||3.1 bar (45psi)|
|Maximum Operating Pressure, during sampling||2 bar (29psi) at 25°C | do not overfill or pressurize collection vessels|
|Maximum Number of Actuations||40|