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TFAI™ ESCO 紊流式無菌隔離器|製藥無菌製程與無菌充填

TFAI™(Turbulent Flow Aseptic Isolator)是 ESCO 的紊流式無菌隔離器,採用紊流(turbulent flow)氣流設計,提供符合無菌製程要求的隔離操作環境。適用於製藥場域的無菌充填、小批量無菌配製與需要完全隔離的無菌操作。可配置正壓(無菌保護)或負壓(操作人員保護)運行模式。

詳細規格請參閱本頁「規格」分頁。報價與客製化評估請洽原拓科技。

適合什麼應用

製藥無菌充填
需要在完全隔離環境中進行藥品充填的小批量製程。正壓配置可維持腔體內無菌環境,即使屏障系統有微小滲漏也是從內向外(保護產品)。

小批量無菌配製
研發階段或小量生產的無菌藥品配製。紊流式氣流在操作區域內提供均勻的空氣品質分佈。

需要紊流氣流環境的操作
部分製程對氣流方向的要求是「均勻分佈」而非「單向流」,TFAI™ 的紊流設計適合這類應用。

細胞治療製程
細胞處理的某些步驟需要在無菌隔離環境中進行,TFAI™ 的隔離設計可降低交叉污染風險。

不適合的應用

  • BSL-3/4 高風險微生物操作——應評估 Airstream Class III BSCSCI Class III,這些設備的設計更偏向生物安全防護
  • 需要單向流(laminar flow)的製程——TFAI™ 採紊流設計,如果製程要求嚴格的單向流環境,應評估其他配置
  • 一般實驗室的微生物操作或細胞培養——Class II A2 型 BSC 已足夠

與同子分類其他設備的定位差異

TFAI™ 在 ESCO Class III 產品線中定位為「製藥無菌製程專用的紊流式隔離器」,與 Airstream Class III(BSL 微生物防護)和 CBI-III / SCI Class III(密封隔離器)的應用場景有所區隔。TFAI™ 的紊流氣流設計與正壓配置選項更適合以「產品無菌保護」為主軸的製藥場景。四款設備的完整比較請見 Class III 生物安全櫃 子分類頁。

安裝規劃與相關資源

TFAI™ 的安裝條件依配置模式(正壓/負壓、循環式/全排式)而異,全排式配置需硬管直連排風系統。建議在採購評估階段就與原拓討論製程需求和設施條件。

延伸閱讀

如需 TFAI™ 的報價、客製化配置討論或整體實驗室建置規劃,歡迎聯繫原拓科技。

品牌:ESCO
產品型號:TFAI III
  • 自動氣流和壓力控制
  • LED燈具,提供優越的照明效果
  • 橢圓形手套孔,最大化手臂活動空間
  • 液壓支撐框架腿,提升操作員舒適度
  • 適用於危險或非危險藥品處理
  • 可用尺寸:4英尺、5英尺和6英尺
TFAI™ ESCO 紊流式無菌隔離器|製藥無菌製程與無菌充填
產品特色

產品特色

Esco Turbulent Flow Aseptic Isolator(TFAI)是一款獨立式隔離器,符合最嚴格的法規要求。該隔離器具備自動氣流和壓力控制,確保在執行測試和其他需要相同環境參數的過程中,能夠提供安全、潔淨且無菌的環境。TFAI具備滿足A級湍流環境的能力,為產品、操作人員和環境之間提供高度的隔離保護。

產品特色:

  • 改良的迷你摺疊分隔技術最大化了過濾器的表面積,提升了效率並延長了過濾器壽命,相較於傳統分隔技術更具優勢。
  • 採用袋進袋出過濾器(Bag-in, Bag-out)技術,可在生物除污後安全移除過濾器,為維護人員及環境提供防止接觸危險材料的保護。
  • 帶有電磁鎖的門機構,配合進出控制的時間延遲機制,確保物品轉移期間工作區保持無菌。
  • 可選配化學漂洗槽,適用於BSL 3和4級應用,以及銳器處理系統,有助於更順暢的工作流程,並減少轉移,從而增強人員保護和無菌環境。
  • 改良的安全更換袖口環允許手套更換,零污染風險。
  • 快速轉移端口提供了一種安全且簡便的方法,用於轉移樣本、材料、供應品和廢物,無需破壞隔離環境。
規格

規格

General Specifications

Turbulent Flow Aseptic
Isolator (TFAI)TM – Double Sided

TFA-2G

TFAI-3G

TFAI-4G

No. of Chambers

2 (1 Process Chamber and 1 Pass Chamber)

Nominal Size Main Chamber (Width)

1200 mm (47.2”)

1600 mm (62.9”)

2000 mm (78.7”)

External Dimensions
(W x D x H)

With BIBO

1200 mm x 1100 mm x 3000 mm

(47.2” x 43.3” x 118.1”)

1600 mm x 1100 mm x 3000 mm

(62.9” x 43.3” x 118.1”)

2000 mm x 1100 mm x 3000 mm

(78.7” x 43.3” x 118.1”)

Without BIBO

1200 mm x 1100 mm x 2600 mm

(47.2” x 43.3” x 102.4”)

1600 mm x 1100 mm x 2600 mm

(62.9” x 43.3” x 102.4”)

2000 mm x 1100 mm x 2600 mm

(78.7” x 43.3” x 102.4”)

With Adjustable Base Stand (Min)

1200 mm x 1100 mm x 2300 mm

(47.2” x 43.3” x 90.6”)

1600 mm x 1100 mm x 2300 mm

(62.9” x 43.3” x 90.6”)

2000 mm x 1100 mm x 2300 mm

(78.7” x 43.3” x 90.6”)

With Adjustable Base Stand (Max)

1200 mm x 1100 mm x 2700 mm

(47.2” x 43.3” x 106.3”)

1600 mm x 1100 mm x 2700 mm

(62.9” x 43.3” x 106.3”)

2000 mm x 1100 mm x 2700 mm

(78.7” x 43.3” x 106.3)

External Dimensions
(W x D x H) with 1000 mm Pass through Chamber

With BIBO

2465 mm x 1100 mm x 3000 mm

(97.0” x 43.3” x 118.1”)

2865 mm x 1100 mm x 3000 mm

(112.8” x 43.3” x 118.1”)

3265 mm x 1100 mm x 3000 mm

(128.5” x 43.3” x 118.1”)

Without BIBO

2465 mm x 1100 mm x 2600 mm

(97.0” x 43.3” x 102.4”)

2865 mm x 1100 mm x 2600 mm

(112.8” x 43.3” x 102.4”)

3265 mm x 1100 mm x 2600 mm

(128.5” x 43.3” x 102.4”)

With Adjustable Base Stand (Min)

2465 mm x 1100 mm x 2300 mm

(97.0” x 43.3” x 90.6”)

2865 mm x 1100 mm x 2300 mm

(112.8” x 43.3” x 90.6”)

3265 mm x 1100 mm x 2300 mm

(128.5” x 43.3” x 90.6”)

With Adjustable Base Stand (Max)

2465 mm x 1100 mm x 2700 mm

(97.0” x 43.3” x 106.3”)

2865 mm x 1100 mm x 2700 mm

(112.8” x 43.3” x 106.3”)

3265 mm x 1100 mm x 2700 mm

(128.5” x 43.3” x 106.3”)

External Dimensions
(W x D x H) with 600 mm Pass through Chamber

With BIBO

2065 mm x 1100 mm x 3000 mm

(81.3” x 43.3” x 118.1”)

2465 mm x 1100 mm x 3000 mm

(97.0” x 43.3” x 118.1”)

2865 mm x 1100 mm x 3000 mm

(112.8” x 43.3” x 118.1”)

Without BIBO

2065 mm x 1100 mm x 2600 mm

(81.3” x 43.3” x 102.4”)

2465 mm x 1100 mm x 2600 mm

(97.0” x 43.3” x 102.4”)

2865 mm x 1100 mm x 2600 mm

(112.8” x 43.3” x 102.4”)

With Adjustable Base Stand (Min)

2065 mm x 1100 mm x 2300 mm

(81.3” x 43.3” x 90.6”)

2465 mm x 1100 mm x 2300 mm

(97.0” x 43.3” x 90.6”)

2865 mm x 1100 mm x 2300 mm

(112.8” x 43.3” x 90.6”)

With Adjustable Base Stand (Max)

2065 mm x 1100 mm x 2700 mm

(81.3” x 43.3” x 106.3”)

2465 mm x 1100 mm x 2700 mm

(97.0” x 43.3” x 106.3”)

2865 mm x 1100 mm x 2700 mm

(112.8” x 43.3” x 106.3”)

Internal Dimensions (W x D x H)

1192 mm x 1080 mm x 842 mm

(46.9” x 42.5” x 33.1”)

1592 mm x 1080 mm x 842 mm

(62.7” x 42.5” x 33.1”)

1992 mm x 1080 mm x 842 mm

(78.4” x 42.5” x 33.1”)

Chamber Sheet Metal

Stainless Steel Type 316L (interior)

Stainless Steel Type 304 (exterior)

Filter Type

ULPA filter (U15)

Support Frame & Service Housing

Stainless Steel Type 304

Chamber Environment

ISO Class 5 (Grade A)

Airflow Type

Turbulent

Lighting Intensity

≥ 500 Lux (≥ 47 foot-candles)

Noise Level

≤ 65 dBA

Electrical Requirement

AC 230-240 V, 50/60 Hz, 1 Ph, 25A

General Specifications

Turbulent Flow Aseptic
Isolator (TFAI)TM – Single Sided

TFA-2G

TFAI-3G

TFAI-4G

No. of Chambers

2 (1 Process Chamber and 1 Pass Chamber)

Nominal Size Main Chamber (Width)

1200 mm (47.2”)

1600 mm (62.9”)

2000 mm (78.7”)

External Dimensions (W x D x H)

With Pod Flange

With BIBO

1200 mm x 780 mm x 3000 mm

(47.2” x 30.7” x 118.1”)

1600 mm x 780 mm x 3000 mm

(62.9” x 30.7” x 118.1”)

2000 mm x 780 mm x 3000 mm

(78.7” x 30.7” x 118.1”)

Without BIBO

1200 mm x 780 mm x 2600 mm

(47.2” x 30.7” x 102.4”)

1600 mm x 780 mm x 2600 mm

(62.9” x 30.7” x 102.4”)

2000 mm x 780 mm x 2600 mm

(78.7” x 30.7” x 102.4”)

With Adjustable Base Stand (Min)

1200 mm x 780 mm x 2300 mm

(47.2” x 30.7” x 90.6”)

1600 mm x 780 mm x 2300 mm

(62.9” x 30.7” x 90.6”)

2000 mm x 780 mm x 2300 mm

(78.7” x 30.7” x 90.6”)

With Adjustable Base Stand (Max)

1200 mm x 780 mm x 2700 mm

(47.2” x 30.7” x 106.3”)

1600 mm x 780 mm x 2700 mm

(62.9” x 30.7” x 106.3”)

2000 mm x 780 mm x 2700 mm

(78.7” x 30.7” x 106.3”)

Without Pod Flange

With BIBO

1200 mm x 695 mm x 3000 mm

(47.2” x 27.4” x 118.1”)

1600 mm x 695 mm x 3000 mm

(62.9” x 27.4” x 118.1”)

2000 mm x 695 mm x 3000 mm

(78.7” x 27.4” x 118.1”)

Without BIBO

1200 mm x 695 mm x 2600 mm

(47.2” x 27.4” x 102.4”)

1600 mm x 695 mm x 2600 mm

(62.9” x 27.4” x 102.4”)

2000 mm x 695 mm x 2600 mm

(78.7” x 27.4” x 102.4”)

With Adjustable Base Stand (Min)

1200 mm x 695 mm x 2300 mm

(47.2” x 27.4” x 90.6”)

1600 mm x 695 mm x 2300 mm

(62.9” x 27.4” x 90.6”)

2000 mm x 695 mm x 2300 mm

(78.7” x 27.4” x 90.6”)

With Adjustable Base Stand (Max)

1200 mm x 695 mm x 2700 mm

(47.2” x 27.4” x 106.3”)

1600 mm x 695 mm x 2700 mm

(62.9” x 27.4” x 106.3”)

2000 mm x 695 mm x 2700 mm

(78.7” x 27.4” x 106.3”)

External Dimensions (W x D x H) with 1000 mm Pass Through Chamber

With Pod Flange

With BIBO

2465 mm x 780 mm x 3000 mm

(97.0” x 30.7” x 118.1”)

2865 mm x 780 mm x 3000 mm

(112.8” x 30.7” x 118.1”)

3265 mm x 780 mm x 3000 mm

(128.5” x 30.7” x 118.1”)

Without BIBO

2465 mm x 780 mm x 2600 mm

(97.0” x 30.7” x 102.4”)

2865 mm x 780 mm x 2600 mm

(112.8” x 30.7” x 102.4”)

3265 mm x 780 mm x 2600 mm

(128.5” x 30.7” x 102.4”)

With Adjustable Base Stand (Min)

2465 mm x 780 mm x 2300 mm

(97.0” x 30.7” x 90.6)

2865 mm x 780 mm x 2300 mm

(112.8” x 30.7” x 90.6”)

3265 mm x 780 mm x 2300 mm

(128.5” x 30.7” x 90.6”)

With Adjustable Base Stand (Max)

2465 mm x 780 mm x 2700 mm

(97.0” x 30.7” x 106.3”)

2865 mm x 780 mm x 2700 mm

(112.8” x 30.7” x 106.3”)

3265 mm x 780 mm x 2700 mm

(128.5” x 30.7” x 106.3”)

Without Pod Flange

With BIBO

2465 mm x 695 mm x 3000 mm

(97.0” x 27.4” x 118.1”)

2865 mm x 695 mm x 3000 mm

(112.8” x 27.4” x 118.1”)

3265 mm x 695 mm x 3000 mm

(128.5” x 27.4” x 118.1”)

Without BIBO

2465 mm x 695 mm x 2600 mm

(97.0” x 27.4” x 102.4”)

2865 mm x 695 mm x 2600 mm

(112.8” x 27.4” x 102.4”)

3265 mm x 695 mm x 2600 mm

(128.5” x 27.4” x 102.4”)

With Adjustable Base Stand (Min)

2465 mm x 695 mm x 2300 mm

(97.0” x 27.4” x 90.6”)

2865 mm x 695 mm x 2300 mm

(112.8” x 27.4” x 90.6”)

3265 mm x 695 mm x 2300 mm

(128.5” x 27.4” x 90.6”)

With Adjustable Base Stand (Max)

2465 mm x 695 mm x 2700 mm

(97.0” x 27.4” x 106.3”)

2865 mm x 695 mm x 2700 mm

(112.8” x 27.4” x 106.3”)

3265 mm x 695 mm x 2700 mm

(128.5” x 27.4” x 106.3”)

External Dimensions (W x D x H) with 600 mm Pass Through Chamber

With Pod Flange

With BIBO

2065 mm x 780 mm x 3000 mm

(81.3” x 30.7” x 118.1”)

2465 mm x 780 mm x 3000 mm

(97.0” x 30.7” x 118.1”)

2865 mm x 780 mm x 3000 mm

(112.8” x 30.7” x 118.1”)

Without BIBO

2065 mm x 780 mm x 2600 mm

(81.3” x 30.7” x 102.4”)

2465 mm x 780 mm x 2600 mm

(97.0” x 30.7” x 102.4”)

2865 mm x 780 mm x 2600 mm

(112.8” x 30.7” x 102.4”)

With Adjustable Base Stand (Min)

2065 mm x 780 mm x 2300 mm

(81.3” x 30.7” x 90.6”)

2465 mm x 780 mm x 2300 mm

(97.0” x 30.7” x 90.6”)

2865 mm x 780 mm x 2300 mm

(112.8” x 30.7” x 90.6”)

With Adjustable Base Stand (Max)

2065 mm x 780 mm x 2700 mm

(81.3” x 30.7” x 106.3”)

2465 mm x 780 mm x 2700 mm

(97.0” x 30.7” x 106.3”)

2865 mm x 780 mm x 2700 mm

(112.8” x 30.7” x 106.3”)

Without Pod Flange

With BIBO

2065 mm x 695 mm x 3000 mm

(81.3” x 27.4” x 118.1”)

2465 mm x 695 mm x 3000 mm

(97.0” x 27.4” x 118.1”)

2865 mm x 695 mm x 3000 mm

(112.8” x 27.4” x 118.1”)

Without BIBO

2065 mm x 695 mm x 2600 mm

(81.3” x 27.4” x 102.4”)

2465 mm x 695 mm x 2600 mm

(97.0” x 27.4” x 102.4”)

2865 mm x 695 mm x 2600 mm

(112.8” x 27.4” x 102.4”)

With Adjustable Base Stand (Min)

2065 mm x 695 mm x 2300 mm

(81.3” x 27.4” x 90.6”)

2465 mm x 695 mm x 2300 mm

(97.0” x 27.4” x 90.6”)

2865 mm x 695 mm x 2300 mm

(112.8” x 27.4” x 90.6”)

With Adjustable Base Stand (Max)

2065 mm x 695 mm x 2700 mm

(81.3” x 27.4” x 106.3”)

2465 mm x 695 mm x 2700 mm

(97.0” x 27.4” x 106.3”)

2865 mm x 695 mm x 2700 mm

(112.8” x 27.4” x 106.3”)

Internal Dimensions (W x D x H)

1192 mm x 630 mm x 842 mm

(46.9” x 24.8” x 33.1”)

1592 mm x 630 mm x 842 mm

(62.7” x 24.8” x 33.1)

1992 mm x 630 mm x 842 mm

(78.4” x 24.8” x 33.1)

Chamber Sheet Metal

Stainless Steel Type 316L (interior)

Stainless Steel Type 304 (exterior)

Filter Type

ULPA filter (U15)

Support Frame & Service Housing

Stainless Steel Type 304

Chamber Environment

ISO Class 5 (Grade A)

Airflow Type

Turbulent

Lighting Intensity

≥ 500 Lux (≥ 47 foot-candles)

Noise Level

≤ 65 dBA

Electrical Requirement

AC 230-240 V, 50/60 Hz, 1 Ph, 25A

產品詢問

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