AseptiBag™ 2D Bioprocess Bags

產品介紹:

AseptiBag 拋棄式的2D生物製程袋,多用於儲存和轉移,由 ™ Gold 由 AseptiFlex ™ -D 薄膜製造具有許多的優點。

規格訊息:

1.高阻隔性能,可保護產品分子

2.堅固、靈活和耐破強度高

3.方便入口和出口快速連接

4.容易握持和懸掛

 

1.無菌培養基、緩衝液及藥物物質在低溫下長期無菌儲存

2.將無菌培養基轉移至生物反應器

3.製程區域之間製程中間體的轉移

4.將藥物成分無菌轉移至製劑設施

 

Materials of Construction

Bag Film

AseptiFlex-D film type FBG-1

Connection Ports

Polycarbonate

Clamps

Polyester

Tubing

Platinum cured silicone

Operating Temperature

-80°C to 45°C

Freeze - Thaw Conditions

Minimum Temperature : -80°C

Maximum No. of Freeze - Thaw Cycles : 05

Burst Pressure with Water

>15 psi

Storage Temperature

-20°C to 45°C

Sterilization

Gamma Sterilizable upto 50 kGy

Assurance

Bacterial Endotoxin

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

Fiber Release

Passes microscopic test for fibers

Particle Release

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

Extractables with WFI

Does not affect the quality of Water for Injection (passes tests as per USP<661>)

Sterility

The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6

Biosafety

Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>

Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>

 

相關規格尺寸

                                                    

Bag Size

A

B

    

3 mL

75mm

55mm

10 mL

90mm

60mm

50 mL

157mm

87mm

100 mL

179mm

92mm

250 mL

189mm

134mm

500 mL

226mm

155mm

1 litre

275mm

200mm

2 litre

350 mm

200 mm

3 litre

378 mm

247 mm

5 litre

410 mm

319 mm

10 litre

620 mm

322 mm

20 litre

520 mm

580 mm

50 litre

860 mm

582 mm

 

For 3ml storage bags

 

For 10ml to 250ml storage bags

 

For 500ml to 50L Storage Bags

 

產品影片:

詢價車:

  • Part NO.
  • Qty
  • Inquiry
  • 2D Bioprocess Bags 3 mL
  • 2D Bioprocess Bags 10mL
  • 2D Bioprocess Bags 50mL
  • 2D Bioprocess Bags 100mL
  • 2D Bioprocess Bags 250mL
  • 2D Bioprocess Bags 500mL
  • 2D Bioprocess Bags 1Litre
  • 2D Bioprocess Bags 2Litre
  • 2D Bioprocess Bags 3Litre
  • 2D Bioprocess Bags 5Litre
  • 2D Bioprocess Bags 10Litre
  • 2D Bioprocess Bags 20Litre
  • 2D Bioprocess Bags 50Litre
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