隔離器

隔離器是一種用于在受控環(huán)境中進(jìn)行無菌操作的設(shè)備，廣泛應(yīng)用于醫(yī)藥、生物技術(shù)、食品加工、化妝品制造等行業(yè)。 我們的生物安全隔離器是實(shí)現(xiàn)這一目標(biāo)的關(guān)鍵技術(shù)，提供無與倫比的安全性和效率在生物醫(yī)藥、食品加工和科研領(lǐng)域，實(shí)驗(yàn)室無菌操作至關(guān)重要。

工作原理：

隔離器通過創(chuàng)建一個(gè)與外界環(huán)境隔離的封閉空間，確保內(nèi)部操作的無菌性。它通常使用高效過濾系統(tǒng)（如HEPA或ULPA過濾器）來過濾進(jìn)入隔離器的空氣，以去除微生物和微粒。

關(guān)鍵組件：

1.  過濾系統(tǒng)：用于過濾進(jìn)入隔離器的空氣，保證無菌環(huán)境。

2.  密封門：確保隔離器在開啟和關(guān)閉時(shí)的密封性。

3.  手套端口：允許操作人員在不破壞無菌環(huán)境的情況下接觸內(nèi)部物品。

4.  滅菌系統(tǒng)：如汽化過氧化氫（VHP）系統(tǒng)，用于周期性地對(duì)隔離器內(nèi)部進(jìn)行滅菌。

5.  監(jiān)控系統(tǒng)：實(shí)時(shí)監(jiān)測和記錄隔離器內(nèi)部的環(huán)境參數(shù)，如溫度、濕度、壓力等。

6.  數(shù)據(jù)記錄：記錄操作過程和環(huán)境參數(shù)，以符合GMP等法規(guī)要求。

操作流程：

1.  準(zhǔn)備階段：對(duì)隔離器進(jìn)行清潔和滅菌，準(zhǔn)備操作環(huán)境。

2.  裝載階段：通過傳遞艙或手套端口將物品裝入隔離器。

3.  操作階段：操作人員通過手套端口或機(jī)械臂在無菌環(huán)境中進(jìn)行操作。

4.  卸載階段：完成操作后，將產(chǎn)品從隔離器中取出，進(jìn)行后續(xù)處理或包裝。

應(yīng)用領(lǐng)域：

1.  無菌藥品生產(chǎn)：用于無菌灌裝、凍干、無菌連接等操作。

2.  生物技術(shù)：用于細(xì)胞培養(yǎng)、基因工程、生物制劑的生產(chǎn)等。

3.  食品加工：用于無菌包裝，確保食品安全。

4.  化妝品制造：用于生產(chǎn)敏感或高活性的化妝品成分。

安全與合規(guī)性：

隔離器的設(shè)計(jì)和操作必須符合行業(yè)安全標(biāo)準(zhǔn)和法規(guī)要求，如GMP、FDA規(guī)定等，以確保產(chǎn)品質(zhì)量和操作人員安全。

維護(hù)與清潔：

定期對(duì)隔離器進(jìn)行清潔、滅菌和維護(hù)，以保持其性能和延長使用壽命。

隔離器是一種高效、可靠的無菌操作解決方案，它通過提供封閉、可控的工作環(huán)境，幫助企業(yè)實(shí)現(xiàn)高標(biāo)準(zhǔn)的產(chǎn)品質(zhì)量和生產(chǎn)效率。

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Short Description:

Aseptic Sterile Isolator: Utilizes a physical barrier to protect the critical operations of sterile drug manufacturing from external environmental contamination, ensuring product integrity and operator safety.

 

Product Features:

• Intelligent Control System: Offers advanced automation for seamless operation and control.

• Experimental Operation Area: Provides a dedicated space for conducting experiments or operations under sterile conditions.

• VHP Sterilization: Utilizes Vaporized Hydrogen Peroxide for effective sterilization within the isolator.

• Automatic Chamber Leak Detection Test: Ensures the integrity of the isolator by automatically testing for leaks.

• Integrated Design: Combines multiple functions and systems into a single, cohesive unit for ease of use and maintenance.

• Internal Bacteria Collector: Helps maintain sterility by collecting and removing contaminants within the isolator.

 

Compliance and Additional Features:

• Designed to meet GMP (Good Manufacturing Practice), FDA (Food and Drug Administration), and USP/EP (United States Pharmacopeia/European Pharmacopeia) standards.

• Equipped with an electrical record and electrical signature for traceability and compliance.

• Features two interlocked inflatable seal doors to achieve near-zero leakage during production.

• Capable of real-time monitoring of wind speed, pressure, temperature, relative humidity, and, with optional sensors, hydrogen peroxide concentration.

• Supports real-time printing and storage of data for record-keeping and analysis.

• Can be operated both automatically and manually for flexibility.     

Technical Specifications:

• Power Supply: AC380V 50HZo 

• Maximum Power: 2500 Wattso         

• Control System: NetSCADA system

• Clean Class: GMP Class A dynamic

 

Application:

The Aseptic Isolator is ideal for applications where a high standard of sterility is required, reducing the need for a high-specification clean room and simplifying the process for personnel, thus lowering operational costs.

This equipment is a crucial asset in the pharmaceutical and biotechnology industries, providing a controlled, sterile environment that minimizes the risk of contamination, which is vital for the production of safe and effective drugs

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隔離器

手套箱

無菌隔離器

isolator

pressure isolatro

aseptic isolators

production isolator

sterile isolator