SatPax® MicroSeal®-VP WFI Low Endotoxin 低内毒素洁净室湿巾

SatPax® MicroSeal®-VP WFI LE is a non-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. 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.

SatPax®MicroSeal®-VPWFI LE是一种非无菌的预饱和聚酯密封边缘低内毒素擦拭巾，在产生极低的颗粒，化学相容性和耐磨性时，可为的清洁应用提供的保护。YL器械，制药和其他受管制的行业，采用Z小的措施可以发挥作用。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。我们的专利表面处理技术使SatPax®MicroSeal®-VPWFI LE能够捕获并保留包括内毒素在内的微粒污染物，其污染程度远远超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出色的吸收性。我们所有的低内毒素擦拭巾均经过批量测试，以确保它们达到或超过USP和FDA标准（基于关键监管行业内毒素的允许阈值）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
建设针织
材质聚酯
封边
解决方案70％IPA / 30％WFI
 APPLICATIONS

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

• 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

清洁制药无菌填充区域，生物安全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


推荐行业

●制药业
●YL器械
●生物技术
●生物制剂
●YL/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（内毒素）？

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

远藤-内部毒素-中毒

脂质A是革兰氏阴性细菌的Z具毒性的成分。它被嵌入在活菌内部，当细菌通过清洁被杀死后，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。

内毒素的常见来源是什么？

内毒素的常见来源是水，土壤，植被，原材料，不良的设备消毒和维护习惯。

革兰氏阴性内毒素的例子有哪些？

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。

您如何测试细菌内毒素的清洁剂？

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

内毒素的检测频率是多少？

伯克希尔对每批产品都进行内毒素测试。

您有什么保证的内毒素限制？

<20 EU /设备– <0.5 EU / mL

FDA工业指南：热原和内毒素测试

“对于YL器械...对于直接或间接接触心血管系统和淋巴系统的产品，限值为0.5 EU / mL或20 EU /器械”

 

Item Number	Size (Metric)	No. / Pack	Pack / Case
SPXVP00112LE	9”x 9” (23cmx23cm)	30	12