Sterile Sampling System
Sterile Sampling Systems provides a pre-assembled sampling solution. It is specially designed for sampling operations at various stages of biopharmaceutical processes such as in-process monitoring of buffer storage, medium preparation, product collection and analysis. To mitigate the risk of residual contamination and ensure the safety of bio-process, the product is sterilized by irradiation prior to delivery.
💡 For product specifications, applications and ordering information, please refer to the attached catalogue.
Property
• Types of sampling container: bags and bottles
• Volume range: sampling bag 50 mL to 1 L, sampling bottle 20 mL to 250 mL
• 2 mm needle, covers a variety of liquid sampling needs in the entire bio-process
• The material of the liquid contact layer of both the sampling bags (ULDPE) and sampling bottles (PC) complies with bio-pharmaceutical requirements
• High transparency and excellent compatibility
• Overmolded needles and tubings for assurance of airtightness and sterility
• Adequate validation documents to ensure safety in use
• Operating temperature range: sampling bag − 80 ° C to 60 ° C, sampling bottle − 80 ° C to 121 ° C
• Maximum operating pressure: single-needle, single-bag products: 0.5 bar; single-needle, 5-bag products: 0.3 bar
• Customization available
Validation Documents
• 100% integrity testing
• USP<665>, Extractable testing
• USP <88> , Class VI plastics
• USP <87>, Cytotoxicity
• USP <788>, Particulate Matter in Injections
• USP<85>, Bacterial Endotoxins
• ISO 11137, Sterility testing
• ISO 10993-4, Hemolysis testing
Characteristics
- Volume range
- sampling bag 50 mL to 1 L, sampling bottle 20 mL to 250 mL
