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PROSAT®Sterile Low Endotoxin

Saturated wipe

Back to our saturated wipes

The sterile wipes PROSAT®Sterile™ Low Endotoxin consist of 100% ladder-proof polyester knitted fabric and are pre-soaked with a mixture of 70% IPA (USP grade) / 30% WFI water. Before sterilisation, the wipes are manufactured very cleanly to reduce endotoxin/pyrogenic contamination to an absolute minimum. They are the first choice for the pharmaceutical industry when it comes to sterile pre-saturated wipes. A high abrasion resistance is a further product feature. The edges are laser-cut and sealed.

Facts

Particle emission (dry)
Particle emission (wet)
Abrasion resistance
Wet cleaning
Dry cleaning
Chemical permanence
Electrostatic behaviour
Softness
Sealed edges
decontaminated
sterile

Saturated wipes

PROSAT® Sterile Low Endotoxin

Knit, 100% PES, with 70% IPA / 30% WFI, low endotoxin, validated sterile

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Properties

  • 100% polyester
  • interlock knitted fabric
  • saturated with 70% IPA/30% WFI water (IPA with USP cleanliness grade > 99%)
  • validated sterile (SAL of 10-6)
  • each batch has a guaranteed endotoxin level of less than 1 EU/device
  • laser cut and sealed edges
  • reclosable PE pouch, packed in a bag and outer bag

Advantages

  • low particle and fibre emission
  • abrasion resistant
  • fast and efficient cleaning
  • reduces the storage of cleaning agents
  • easier to transport, store and use
  • even application of the cleaning solution

Applications

  • highly critical cleanrooms in the pharmaceutical industry
  • for wet cleaning in sterile environment including process tools and other special equipment

Product recommen­dation based on cleanroom classes


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ABCDE

Of course, cleanroom wipes used in ISO 5 can also be used in ISO 9, but in this case the economic efficiency and usefulness should be considered.

A 1 to 1 allocation of cleanroom wipes to an air cleanliness class according to ISO 14644-1 is not possible. Recommendations can only be made on the basis of special properties relevant from a cleanroom technical point of view, such as "abrasion resistance" or "particle emission". Users can find further information on this in VDI Guideline 2083 Part 9.2.

Technical data

Properties   Unit of measurementValueTest method
Material (fabric)     100% PES
(no-run interlock knit)
 
Saturation solution     70% IPA (USP grade) / 30% WFI
(Water for injection)
 
Edge processing     Laser cut  
Mass per unit area   g/m2 140  
Thickness   mm n.s.  
NVR
Non-volatile residues
IPA based
DI-water based
g/m²
g/m²
0.01
0.01
IEST-RP-CC004.3, Sec. 7.1.2
IEST-RP-CC004.3, Sec. 7.1.2
Particle residues ≥ 0.5 µm x 106/m2 2.6 IEST-RP-CC004.2, Sec. 5.1
Fibre Residues > 100 µm x 103/m2 0.142 IEST-RP-CC004.2, Sec. 5.2
Ionic Residues Sodium (Na+)
Chloride (ClO2-)
ppm
ppm
0.18
0.003
IEST-RP-CC004.3, Sec. 7.2.2
IEST-RP-CC004.3, Sec. 7.2.2
Sterilisation validated sterile SAL 10-6 yes n.s.
Guaranteed endotoxin level   Endotoxin Unit (EU)/wipe < 1 n.s.
  DimensionsPU per lined caseArt. no.  
  9" x 9"
(~ 23 x 23 cm)
12" x 12"
(~ 30 x 30 cm)
12" x 12"
(~ 30 x 30 cm)
550 pcs.
(10 pcs./Pouch) triple bagged
450 pcs.
(30 pcs./Pouch) double bagged
300 pcs.
(10 pcs./Pouch) triple bagged
59805

59805-01

59805-02
 

Note

The manufacturer's technical data listed above are typical values at the time of publication. They are not specifications. All data are without guarantee, changes are possible without prior notice.
Due to different test methods depending on the respective manufacturers and test laboratories, most of the given values cannot be compared one-to-one with those of other manufacturers/wipes.
Independent tests can be commissioned on request.

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