Ideal for cleaning pharmaceutical aseptic fill areas, biosafety cabinets, and other critical surfaces.
• Implantable Devices
• Instruments & Tools
• Surgical Kits & Areas
● Pharmaceutical Manufacturing
● Medical Device
● 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”