产品名称：Sterile SatPax® 550 WFI Low Endotoxin低内**洁净室湿巾

Sterile SatPax® 550 WFI LE is a sterile pre-saturated low endotoxin wipe comprised of an exceptionally clean  meltblown polypropylene non-woven substrate. This wipe is pre-wetted with a 70% IPA and 30% WFI (water for injection) prepared using a validated aseptic sterile filtration process. 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 endotoxin levels. Sterile SatPax® 550 WFI LE is a validated sterile product that is gamma irradiated to assure sterility. 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.

无菌SatPax®550 WFI LE是一种无菌的预饱和低内**擦拭巾，由非常干净的熔喷聚丙烯无纺布基材组成。 用经验证的无菌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。 先进的构造和颗粒捕获功能可作为一种强大的载体，用于从表面，产品或过程中去除内**，而不会增加未经测试的内巾水平对内**水平的额外风险。 无菌SatPax®550 WFI LE是经过验证的无菌产品，经过伽玛射线辐照以确保无菌。 此外，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 5-8
Construction	Nonwoven
Material	Polypropylene
Edge	Knife-Cut
Solution	70% IPA / 30% WFI

ISO Class 5-8级
建筑无纺布
材料聚丙烯
切边刀
解决方案70％IPA / 30％WFI

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”

应用领域

清洁制药无菌填充区域，生物**柜和其他关键表面的理想选择。
•注射剂
•植入式装置
•仪器和工具
•手术包和区域


**行业

●制药业
●医疗器械
●生物技术
●生物制剂
●医疗/手术室
●其他主要的EPA，FDA监管行业

经常问的问题

什么是热原（内**）？

IEST-RP-CC023.2将热原定义为“能够发烧的物质。常见的热原是内**，内**是构成革兰氏阴性**外壁的一类脂多糖，本身就是细胞代谢的副产物。”

远藤-内部**-中毒

脂质A是革兰氏阴性**的*具毒性的成分。它被嵌入在活菌内部，当**通过清洁被杀死后，细胞外壁碎屑被释放出来，死细胞变得有毒。需要将其从表面移除。

内**的常见来源是什么？

内**的常见来源是水，土壤，植被，原材料，不佳的设备**和维护习惯。

革兰氏阴性内**的例子有哪些？

伯克霍尔德氏菌，假单胞菌，罗尔斯通尼亚，埃希氏菌，沙雷氏菌，嗜单胞菌。

您如何测试**内**的清洁剂？

伯克希尔使用LAL – Li变形细胞溶解试验。 FDA工业指南：热原和内**测试“ 30多年来，FDA接受了使用A血变形细胞裂解液LAL进行内**替代兔子热原测试。”

内**的检测频率是多少？

伯克希尔对每批产品都进行内**测试。

您有什么保证的内**限制？

<20 EU /设备– <0.5 EU / mL

FDA工业指南：热原和内**测试

“对于医疗器械...对于直接或间接接触心血管系统和**系统的产品，限值为0.5 EU / mL或20 EU /器械”

Item Number	Size (Metric)	No. / Pack	Pack / Case
SSP55000524LE	9" x 11" (22cm x 28cm)	50	24