TAKEONE<sup>®</sup> Aseptic Sampling System

TAKEONE® Aseptic Sampling System


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 .....




TAKEONE® Aseptic Sampling System


Quick, Accurate, Reliable and Safe

  • Closed and Aseptic Sampling
  • Perfectly Representative Samples
  • Pre-assembled and Ready-to-use
  • On Demand Sample Collection
  • OOperator-friendly Ergonomic Design
  • Fully Single-use and Disposable

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.

 

Quick and Easy Aseptic Sampling


Reduce Risk and Break the Soft-Parts Life Cycle


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®


Accurate Aseptic Sampling


A Collection Vessel for Each Sampling Type

Collect samples in the ideal sample container for the analysis type by selecting from our thorough list of options.

Bottles

Fully-contained sampling pathway with graduations for improved sampling accuracy
- PETG with 2-port Mycap Bottle Closure
- 30mL, 60mL, 125mL, 250mL, 500mL and 1000mL
- -40°C to 40°C
- USP VI|TSE-BSE Compliant

Needle-free Septum

Expand capacity, flexibility and reduce costs. Improved accuracy for process monitoring and gas analysis.
- PC Silicone
- Validated for up to 140 samples per line
- -40°C to 40°C
- USP VI|TSE-BSE Free

Centrifuge Tubes

Fully-contained sampling pathway
15mL Polystyrene with 2-port Mycap Bottle Closure
- ideal for endotoxin sampling due to low binding affinity
- highly accurate volume

50mL Polypropylene with 2-port Mycap Bottle Closure
- with precise graduations for accurate volume sampling
- -40°C to 40°C
- USP VI|TSE-BSE Compliant

Bags

Fully-contained sampling pathway suitable for any sampling need.
- EVA S71 Film
- 50mL, 150mL, 250mL, 500mL and 1000mL
- -70°C to 40°C
- USP VI|TSE-BSE Free

 


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

Media|Buffer Preparation

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



Reliable Aseptic Sampling

Cross-Section of TAKEONE®, Before and After Actuation

Cross-Section of TAKEONE®, During Actuation




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.


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 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.



Safe Aseptic Sampling

No Assembly, No Disassembly

 

Robust Materials of Construction

Avoid risk of repetitive-use hand injury and protect operators from handling sharp.

 

Thoughtfully selected materials ensure the device meets the most rigorous of process conditions.


TAKEONE® Device Materials of Construction

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


TAKEONE® Performance Specifications

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° (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

 

Publications & Downloads

 

Brochure TAKEONE®

 

Flyer TAKEONE® Time Saving

   

Sampling Devices in Bioburden Control

 

Aseptic Sampling Best Practices: Gas Analysis

 

Aseptic Sampling Best Practices: Endotoxin Assay


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TAKEONE® Aseptic Sampling System

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 .....