OverviewSingle-use sterile sampling system designed to preserve sample integrity and prevent cross-contamination during bioprocessing and pharmaceutical production. Available in multiple pack sizes and configurable to standard connectors and tubing materials to match process requirements.
Applications- Maintains sample purity during drug formulation and production
- Supports sterile sampling in cell culture, upstream and downstream processing
- Collection of QC samples for laboratory analysis
Certifications- Class VI Plastics as per USP <88>
- Cytotoxicity as per USP <87>
- USP <85> Bacterial Endotoxins
- USP <661.1> Extractable metals
- SP <788> Sub visible particulate matter
- USP <71> & ISO <11737-1> Sterility assurance
Features / Benefits- Minimizes risk of cross-contamination with single-use sterile design
- Ensures repeatable, accurate sample collection
- Compliant with relevant USP and ISO biocompatibility and sterility standards
- Customization options to fit specific process interfaces
Characteristics (summary)- Reduces need for cleaning and lowers false-positive risks compared with reusable sampling systems
- Multiple configurations and sizes to cover a broad range of process requirements
Components / Construction (table)1 | Bag | 9101 Infuflex Film
2 | Tube | TPE and Silicone
3 | Needless sampling port | Body - Polycarbonate; Septum - Silicone
4 | Female Luer Lock | Polypropylene
5 | Male Luer Plug | Polypropylene
6 | Sampling needle | Needle - SS 316L; Body - Polypropylene; Septum - Silicone
Standard Sizes Available (catalogue numbers)# | CATALOGUE NO. | Description
1 | 2D-SS-050M-01 | Sterile sampling system with 1 x 50ml bag
2 | 2D-SS-100M-01 | Sterile sampling system with 1 x 100ml bag
3 | 2D-SS-250M-01 | Sterile sampling system with 1 x 250ml bag
4 | 2D-SS-500M-01 | Sterile sampling system with 1 x 500ml bag
5 | 2D-SS-001L-01 | Sterile sampling system with 1 x 1L bag
Specifications- Bag material: 9101 Infuflex Film
- Tubing: TPE and Silicone options
- Needless sampling port: Body - Polycarbonate; Septum - Silicone
- Female Luer Lock: Polypropylene
- Male Luer Plug: Polypropylene
- Sampling needle: Needle - SS 316L; Body - Polypropylene; Septum - Silicone
- Sterility & biocompatibility: Meets USP <71>, <85>, <87>, <88>, USP <661.1> and SP <788> parameters and ISO <11737-1> sterility assurance
- Available standard pack sizes: 50 ml, 100 ml, 250 ml, 500 ml, 1 L (see catalogue numbers)
- Customization: Options available to meet specific process requirements