产品名称：Sterile SatPax® MicroSeal®-VP WFI Low Endotoxin低内**洁净室湿巾

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.

无菌SatPax®MicroSeal®-VPWFI LE是一种无菌的预饱和聚酯密封边缘低内**擦拭巾，在低的颗粒产生，化学相容性和耐磨性方面提供了大的保护，适用于关键的医疗清洁应用设备，制药和其他受管制的行业，而采取小的措施可以发挥大作用。用经验证的无菌过滤工艺制备的70％IPA和30％WFI（注射用水）预先擦拭该湿巾。我们的表面处理技术使SatPax®MicroSeal®-VPWFI LE能够捕获并保留包括内**在内的微粒污染物，其污染程度远远*出了典型的聚酯密封边缘无尘擦拭布的能力。此外，空转联锁编织结构可提供光滑的表面纹理和吸收性。无菌SatPax®MicroSeal®-VPWFI LE是经过验证的无菌产品，经过伽玛射线辐照以确保无菌。我们所有的低内**擦拭巾均经过批量测试，以确保它们达到或过USP和FDA标准（基于关键监管行业内**的大允许阈值）设定的要求。

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

ISO Class 3-5级
建筑针织
原料聚酯
封边
解决方案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”