UA-44035381-1

ASESS® Aseptic Sampling Systems

mdi ASESS® are gamma irradiated single use disposable systems for aseptic fluid sampling at various stages in pharmaceutical and biopharmaceutical processing. These systems minimize chances of false positives and reduce cleaning requirements over traditional sampling systems.

Aseptic sampling of:

  • Sterile bulk and sterile transfers
  • Vaccine formulations at different maturation steps
  • Fermentation cycles
  • Cell culture from bioreactors
Materials of Construction
Septum Platinum Cured Silicone
Needle 316L SS
Bag Film Multilayered Film type FBG-1
Tubing

Thermoplastic Elastomer
Platinum Cured Silicone
Operational
Operating Pressure 5 psi
Steam in Place (Sanitary flange adaptor assembly) 125ºC for 30 min
Operating Temperature Range -20ºC to 60ºC
Assurance
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

Sampling Systems

Gamma Sterile ASESS® Aseptic Sampling Systems with 2mm Needle

A044XXXXXXSS3015x100 mL sampling bags and 1x250 mL drain bag
A023XXXXXXSS30110x100 mL sampling bags and 2 x 250 mL drain bags
A028XXXXXXSS3011x100 mL sampling bag
A029XXXXXXSS3011x250 mL sampling bag

Gamma Sterile ASESS® Aseptic Sampling Systems with 1mm Needle

A1359XXXXXSS3015x250 mL sampling bags and 1x250 mL drain bag
A1360XXXXXSS3011x100mL sampling bag

Accessories

Sampling Port

ASPC25XXXXXXX0125mm sampling port connection for both 1mm or 2mm needle, single sampling port
ASPCIG02XXXXX01Ingold Adapter - Sampling port connection for both 1mm or 2mm needle, two sampling ports
ASPCIG02XXLXX01Ingold Adapter for Longer Ingold Ports- Sampling port connection for both 1mm or 2mm needle, two sampling ports
ASPC5005XXXXX0150mm sampling port connection for both 1mm or 2mm needle, five sampling ports

Crimping Tool

CTLXXXXXXXXXX01

CrimGard Crimped Tube Cover

CGCXXXXXXXXXX02 for pack size of 10

ASESS® Port Blind

AASSBXXXXXXXX02 for pack size of 10

Customization

ASESS® Aseptic Sampling Systems can be customized to suit user requirements regarding tubing sizes, sizes, sampling ports, and vessel port. The technical feasibility of the required design is established based on available components and an initial drawing is proposed. Products prototyping and final approval lead to customized system realization.

User Manual Download
Brochure/Leaflet Download
Certificate of Quality Download

Validated for:

  • Sterility as per USP <71>
  • Class VI Plastics as per USP <88>
  • Cytotoxicity as per USP <87>
  • Bacterial Endotoxin <0.25EU/ml
  • TOC as per USP <643>
  • Conductivity as per USP <645>