ASESS® Aseptic Sampling Systems with Precision Sampling Syringe
mdi ASESS® sampling systems with sampling syringe are designed for up to 5mL precision volume sampling for testing applications involving small volumes. This isspecially useful when sampling high value process fluids, for example in manufacture of monoclonal antibodies and orphan drugs. These precision sampling syringeshave a least count of 200µl with an accuracy of +5%.
The easy to use accurate volume, precision sampling syringes have been specially designed to ensure sterility of the drawn sample. The plunger moves within a speciallydesigned bellow sealed in the barrel to ensure that there is no microbial ingress from the environment.
Precision volume aseptic sampling for testing of:
- Cell viability
- Cell density
- Bioburden
- Sterility
- Bacterial endotoxins
| Materials of Construction | |||
| Syringe | Polycarbonate | ||
| Plunger | Polypropylene | ||
| Septum | Platinum Cured Silicone | ||
| Needle | 316L SS | ||
| Tubing |
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| Operational | |||
| Steam in Place (Sanitary flange adaptor assembly) | 125ºC for 30 min | ||
| Sterilization | Gamma sterilized up to 50 kGy | ||
| Assurance | |||
| Bacterial Endotoxin | Bacterial Endotoxin <0.25EU/ml | ||
| Bioburden Levels | Bioburden level is < 1000 cfu/device device as per ISO 11737-1 | ||
| Integrity | 100% Integrity tested | ||
| Non Animal Origin | Comply with the requirements laid down in the “Note for Guidance EMEA/410/01, rev. 03” for inputs of Non Animal Origin | ||
| Sterility | Gamma Irradiated | ||
| Brochure/Leaflet | Download |