UA-44035381-1
  • ASESS<sup>®</sup> Aseptic Sampling Systems with Precision Sampling Syringe

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

Thermoplastic Elastomer
Platinum Cured Silicone
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