產品名稱：Sterile SatPax® MicroSeal®-VP WFI Low Endotoxin低內**潔淨室濕巾

Sterile SatPax® MicroSeal®-VP WFI LE is a sterile pre-saturated polyester sealed-edge low endotoxin wipe that provides maximum protection when it comes to critically low particle generation, chemical compatibility, and abrasion resistance for the most critical cleaning applications for the medical device, pharmaceutical, and other regulated industries where the smallest measure can make the biggest difference. This wipe is pre-wetted with a 70% IPA and 30% WFI (water for injection) prepared using a validated aseptic sterile filtration process. Our patented surface treatment enables the SatPax® MicroSeal®-VP WFI LE to capture and retain particulate contamination including endotoxins well beyond the capabilities of a typical polyester sealed edge clean room wipe. In addition, a no-run interlock knit construction provides a smooth surface texture and excellent absorbency. Sterile SatPax® MicroSeal®-VP WFI LE is a validated sterile product that is gamma irradiated to assure sterility. 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.

無菌SatPax®MicroSeal®-VPWFI LE是一種無菌的預飽和聚酯密封邊緣低內**擦拭巾，在低的顆粒產生，化學相容性和耐磨性方麵提供了大的保護，適用於關鍵的醫療清潔應用設備，製藥和其他受管製的行業，而采取小的措施可以發揮大作用。用經驗證的無菌過濾工藝製備的70％IPA和30％WFI（注射用水）預先擦拭該濕巾。我們的表麵處理技術使SatPax®MicroSeal®-VPWFI LE能夠捕獲並保留包括內**在內的微粒汙染物，其汙染程度遠遠*出了典型的聚酯密封邊緣無塵擦拭布的能力。此外，空轉聯鎖編織結構可提供光滑的表麵紋理和吸收性。無菌SatPax®MicroSeal®-VPWFI LE是經過驗證的無菌產品，經過伽瑪射線輻照以確保無菌。我們所有的低內**擦拭巾均經過批量測試，以確保它們達到或過USP和FDA標準（基於關鍵監管行業內**的大允許閾值）設定的要求。

ISO Class	Class 3-5
Construction	Knitted
Material	Polyester
Edge	Sealed Edge
Solution	70% IPA / 30% WFI

ISO Class 3-5級
建築針織
原料聚酯
封邊
解決方案70％IPA / 30％WFI

APPLICATIONS

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

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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”