產品名稱：Gamma Wipe® MFLP Low Endotoxin 低內**潔淨室濕巾

Gamma Wipe® MFLP LE is a sterile non-woven low endotoxin wipe engineered for advanced performance and minimizing the presence of harmful endotoxins in the pharmaceutical, medical device, and other key regulated industries. Comprised of a specially formulated blend of polyester and DuPont Lyocell, this wipe excels at wiping delicate and scratch prone surfaces while providing outstanding absorbency and chemical compatibility. The advanced substrate construction provides strong particle entrapment capabilities for removing endotoxins from surfaces, end-products, or processes. Using sterile wipes not tested for and verified for low endotoxins levels creates risk as it can contribute to endotoxin contamination. Gamma Wipe® MFLP LE is a validated sterile product that is gamma irradiated to assure consistent 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.

GammaWipe®MFLP LE是一種無菌無紡布低內**擦拭布，旨在提高性能，並大程度降低製藥，醫療設備和其他關鍵監管行業中有害內**的存在。由特殊配方的聚酯和杜邦萊賽爾纖維混合物組成，這種擦拭布擅長擦拭易碎和易刮擦的表麵，同時具有吸收性和化學相容性。基材結構提供了強大的顆粒捕獲能力，可從表麵，產品或工藝中去除內**。使用未經測試且未經驗證的低內**水平的無菌濕巾會帶來風險，因為它可能會導致內**汙染。 GammaWipe®MFLP LE是經過驗證的無菌產品，經過伽瑪射線輻照以確保一致的無菌性。此外，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 5-8
Construction	Nonwoven
Material	Polyester / Lyocell Blend
Edge	Knife-Cut

ISO Class 5-8級
建築無紡布
材料聚酯/萊賽爾混紡
切邊刀

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”

應用領域

清潔製藥無菌填充區域，生物**櫃和其他關鍵表麵的理想選擇。
•注射劑
•植入式裝置
•儀器和工具
•手術包和區域


**行業

●製藥業
●醫療器械
●生物技術
●生物製劑
●醫療/手術室
●其他主要的EPA，FDA監管行業

經常問的問題

什麼是熱原（內**）？

IEST-RP-CC023.2將熱原定義為“能夠發燒的物質。常見的熱原是內**，內**是構成革蘭氏陰性**外壁的一類脂多糖，本身就是細胞代謝的副產物。”

遠藤-內部**-中毒

脂質A是革蘭氏陰性**的具毒性的成分。它被嵌入在活菌內部，當**通過清潔被殺死後，細胞外壁碎屑被釋放出來，死細胞變得有毒。需要將其從表麵移除。

內**的常見來源是什麼？

內**的常見來源是水，土壤，植被，原材料，不佳的設備**和維護習慣。

革蘭氏陰性內**的例子有哪些？

伯克霍爾德氏菌，假單胞菌，羅爾斯通尼亞，埃希氏菌，沙雷氏菌，嗜單胞菌。

您如何測試**內**的清潔劑？

伯克希爾使用LAL – Li變形細胞溶解試驗。 FDA工業指南：熱原和內**測試“ 30多年來，FDA接受了使用A血變形細胞裂解液LAL進行內**替代兔子熱原測試。”

內**的檢測頻率是多少？

伯克希爾對每批產品都進行內**測試。

您有什麼保證的內**限製？

<20 EU /設備– <0.5 EU / mL

FDA工業指南：熱原和內**測試

“對於醫療器械...對於直接或間接接觸心血管係統和**係統的產品，限值為0.5 EU / mL或20 EU /器械”

Item Number	Size (Metric)	No. / Pack	Pack / Case
GWMFLPST25LE	12" x 12" (30cm x 30cm)	20	25