PETG Vented Bottle Assembly

產品介紹:

伽瑪滅菌通風瓶組件適用於生物製藥產品和試劑的安全轉移、取樣和儲存。

規格訊息:

1.輕量化的組件

2.滅菌級 0.2μm PVDF 通風過濾器,可防止在高價值產品填充和取出過程中微生物的進入。

3.獨特的瓶蓋設計可以輕鬆打開,無需旋轉管道和通風口連接。

 

1.細胞培養基的儲存與轉移

2.無菌取樣

3.無菌灌裝和轉移

 

Materials of Construction

Cap

 Polypropylene

Inlet Tube

 Thermoplastic Elastomer (TPE)

Bottle

 PETG

Dip Tube

 Platinum Cured Silicone (PCS)

Assurance

100% Integrity Tested

 Pressure Leak Test

Toxicity

 Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics

Fiber Release

 Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)   (6) for fiber release

Particle Release

 Complies with USP <788> test for particulate matter in injections

Endotoxin Testing

 Aqueous extracts exhibit <0.25 EU/ml as established by Limulus   Amebocyte Lysate (LAL) Test as per USP <85>

Extractables

 Passes NVR test as per USP <661>

Sterility

 mdi PETG vented bottle assemblies are sterilized by gamma irradiation to   provide a sterility assurance level of 10-6. The sterilization process has   been validated as per ISO 11137-2 which includes dose verification, dose   mapping and quarterly dose audits.

 The sterilization dose of 25 kGy has been substantiated through the   careful definition of the test samples, bioburden testing of multiple lots of   the selected test samples, calculation of verification dose, and sterility   testing.

 

Hydrophobic PVDF Vent Filter

Capacity

Filter Size

Upto 1000mL

25 mm

2000 mL

50 mm

 

Inlet Tube

18 inch with press in plug

 

客製化

可根據使用者對管道、配件、端部連接、瓶子尺寸和連接器的要求進行客製化。

產品影片:

詢價車:

  • Part NO.
  • Qty
  • Inquiry
  • PETG Vented Bottle Assembly 50mL
  • PETG Vented Bottle Assembly 60mL
  • PETG Vented Bottle Assembly 125mL
  • PETG Vented Bottle Assembly 250mL
  • PETG Vented Bottle Assembly 500mL
  • PETG Vented Bottle Assembly 1000mL
  • PETG Vented Bottle Assembly 2000mL
  • PETG Vented Bottle Assembly 客製化
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