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SatPax® MFLP WFI Low Endotoxin
SatPax® MFLP LE is a non-sterile pre-saturated low endotoxin wipe engineered for advanced performance and minimizing the presence of harmful exotoxins in the pharmaceutical, medical device, and other key regulated industries. This wipe is presaturated with a 70% IPA and 30% WFI (water for injection) prepared using a validated aseptic sterile filtration process Comprised of a specially formulated blend of polyester and DuPont Lyocell, this wipe excels at wiping delicate and scratch prone surfaces while providing outstanding absorbency. The advanced construction and particle entrapment capabilities serve as a powerful vehicle for removing endotoxins from surfaces, end-products, or processes without adding additional risk from wipes not tested for low endotoxin levels. In addition, all of our low endotoxin wipes are lot-to-lot tested to ensure they meet or exceed the requirements set by USP & FDA standards based on the maximum allowable thresholds for endotoxins across key regulated industries.
Specification

Additional Information

ISO Class Class 3-5
Construction Nonwoven
Material Poly / Cell
Edge Sealed Edge
Solution 70% IPA / 30% WFI
Downloads Product Information Sheet (PDF)
Additional Info

APPLICATIONS

Ideal for cleaning pharmaceutical aseptic fill areas, biosafety cabinets, and other critical surfaces.

• Injectables
• Implantable Devices
• Instruments & Tools
• Surgical Kits & Areas


RECOMMENDED INDUSTRIES

● Pharmaceutical Manufacturing
● Medical Device
● Biotech
● Biologics
● Healthcare / Surgical Suite
● Other key EPA, FDA regulated industries

FREQUENTLY ASKED QUESTIONS

What is a pyrogen (endotoxin)?

IEST-RP-CC023.2 defines a pyrogen as “A substance capable of producing fevers. The most common pyrogens are endotoxins, a class of lipopolysaccharides that comprise the outer wall of Gram-negative bacteria and are themselves byproducts of cell metabolism.”


Endo - Internal Toxin - Poison


Lipid A is the most toxic component of a gram-negative bacteria. It is embedded internally in the living bacteria.When bacteria is killed through cleaning, the outer cell wall detritus is released and the dead cell becomes toxic. It needs to be removed from the surface.


What are common sources of endotoxins?

Common sources of endotoxins are water, soil, vegetation, raw materials, poor equipment sanitization and maintenance practices.


What are examples of gram-negative endotoxins?

Burkholderia, Pseudomonas, Ralstonia, Escherichia, Serratia, Stenotrophomonas.


How do you test wipers for bacterial endotoxins?

Berkshire uses the LAL – Limulus Amebocyte Lysate test. FDA Guidance for Industry: Pyrogen and Endotoxins Testing “For more than 30 years, FDA has accepted the use of Limulus Amoebocyte Lysate LAL test for endotoxins in lieu of the rabbit pyrogens test.”


What is the frequency of endotoxin testing?

Berkshire tests each lot for endotoxins.


What are your guaranteed endotoxin limits?

<20 EU/device – <0.5 EU/mL


FDA Guidance for Industry: Pyrogen and Endotoxins Testing


“For medical devices...the limit is 0.5 EU/mL or 20 EU/ device for products that directly or indirectly contact the cardiovascular system and lymphatic system”


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SatPax® MFLP WFI Low Endotoxin

Order Info

Item Number Size (Metric) No. / Pack Pack / Case Price qty
Item Number SPXMFLP00112LE Size (Metric) 9" x 9" (23cm x 23cm) No. / Pack 75 Pack / Case 12 Price
$568.95
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