TakeOne® Aseptic Sampling System - Predesigned Configurations

TakeOne^® solutions are ideal for all in-process sampling requirements in a drug production process.

Quick and Easy Setup

Pre-Assembled

• TakeOne^® arrives fully assembled and ready for installation to the sampling point.
• Eliminate assembly operations where valuable time is lost.

Ready-to-Use

• TakeOne^® has no spare, reused parts or accessories.
• Eliminate the risk of production delays or batch contaminations from lost or damaged parts.

Single-Use

• Simply dispose of the TakeOne^® device at the end of the batch.
• Eliminate the risk of contamination from improper or ineffective cleaning of reusable parts.

Reliable Performance

100% Leak Tested

• Each sampling line of every TakeOne^® passes a leak-test prior to shipment.
• Rely on TakeOne^® for dependable and repeatable performance, lot after lot.

Preserve Process and Sample Integrity

• The resilient deformable aseptic chamber is at the core of the device.
• Bacterial ingress validation demonstrates the chamber form a microbial barrier after actuation.
• As verified by statistical analysis, the aseptic chamber returns to a like-new condition after 40 actuations and 10 SIP cycles after actuation.

Robust Design for Operator and Process Safety

316L Stainless Steel Faceplate

• Careful selection of the materials of construction make the TakeOne^® sampling device engineered to perform.
• The sanitary fitting complies with ASME-BPE standards to ensure a correct and secure fit to process equipment.
• Trust the 316L stainless steel fitting of TakeOne^® to perform as you would any fitting, even during aggressive SIP conditions.

Spring-Return Actuator

• An internal spring automatically retracts the needle back into the device after sampling.
• This feature affords protection from exposure to sharps and encourages sample volume control.

Pre Designed Solutions for Every Process Area

In-process sampling is a requirement at each process step to ensure a drug products' safety, identity, strength, purity and quality. Yet there are some differences in the sampling requirements between Process Areas. Leveraging our expertise gained from helping our customers succesfully take hundreds of thousands of aseptic samples, Sartorius presents a family of Pre Designed Solutions that meet the general sampling requirements of each process area.

Cell Culture and Downstream Intermediates

• Check for sterility, bioburden and non-host organisms prior to and just after inoculation, after recovery and hold steps and at batch conclusion
• Regular checks cell count, viability, density and other critical process parameters

Buffer and Media Preparation

• Check for sterility prior to and after additions or transfers
• Check for endotoxin prior to and after additions or transfers
• Regular checks of pH, titration, conductivity, concentrations and other critical process parameters

Drug Substance Purification

• Check for bioburden prior to 0.2µm filtration, during equipment calibration, after any additions and at end of process
• Check for endotoxin during equipment calibration, after any additionss, at end of end of process, after chomatography steps and at end of end of process
• Regular checks of osmolality, viral|protein concetration, pH and other critical process parameters

Drug Product Formulation

• Check for bioburden prior to 0.2µm filtration, prior to fill and finish, after filling, at end of hold time and at end of process
• Check for endotoxin prior to fill and finish, after filling, at end of hold time and at end of process
• Regular checks of osmolality, viral|protein concetration, pH and other critical process parameters