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Containment, Delivered: Suzhou Pharma Machinery Anti-Cancer Medicine Isolator

As a professional supplier in the pharmaceutical equipment field, Suzhou Pharma Machinery can provide customized solutions for various scenarios, such as VHP isolators, tablet press isolators, and full-process medicine production line isolators. Recently, the anti-cancer medicine isolator we designed specifically for a client has been successfully delivered. This closed protective equipment not only strictly complies with USP 800 and OEB4-6 safety standards but also precisely meets the client's production process requirements. Below, we will detail its core advantages and application value for you.

 

Key equipment for ensuring the safe handling of highly active anti-cancer medicine:

The anti-cancer medicine isolator is a crucial device in the pharmaceutical industry specifically designed for the handling of highly active, highly toxic, and highly allergenic medicine. It plays a vital role in providing safety protection during the production, preparation, and handling of anti-cancer medicine.

Main applications:

Medicine weighing and ingredient preparation: Provide a sealed negative pressure environment for operations such as packaging, weighing, ingredient preparation, and sampling of the medicine;

Highly active medicine production: Protect operators from exposure to medicine dust or liquids;

Raw material processing: Used for the sealed protection of key process equipment for raw materials.

General Parameters and Features:

Items

Specific contents and standards

Core protection objectives

  • Protect personnel and environment: Prevent the leakage of toxic medicines or pathogens.
  • Protect the sterility of medicines: Ensure that the medicines are operated in a sterile environment and are not contaminated.

Pressure control

Negative pressure design: For handling hazardous substances such as anti-cancer medicines, strict requirements are imposed to ensure that harmful substances do not leak out.

Key performance indicators

  • Negative pressure design: For handling hazardous substances such as anti-cancer medicines, strict requirements are imposed to ensure that harmful substances do not leak out.
  • Key performance indicators: Protection level (OEB): Usually, it needs to reach OEB5 (the occupational exposure limit OEL is < 1 µg/m³), and for extremely active medicines such as ADC, the exposure concentration should be < 10 ng/m³.
  • Leakage rate: Key indicator of cabin sealing, high-standard equipment requires < 0.25% vol/hr.
  • Cleanliness level: The sterile operation area needs to reach ISO 5 level (Class A) cleanliness.
  • Gap wind speed: Emergency guarantee when leakage occurs, usually maintaining ≥ 0.5 m/s inward wind speed at the damaged opening.

Main technical features

  • High-efficiency filtration system: Both incoming and outgoing air are equipped with HEPA or ULPA filters, with a filtration efficiency of over 99.995%.
  • Online sterilization (SIP)/purification: Integrated systems such as vaporized hydrogen peroxide (VHP) are integrated to conduct efficient sterilization of the cabin interior.
  • In-situ cleaning (CIP/WIP): Integrated cleaning nozzles are integrated, allowing for cleaning of the cabin interior surfaces in a sealed state to avoid personnel contact.
  • Safe replacement mechanism: Components such as filters and gloves adopt "bag-in-bag-out" (BIBO) designs, eliminating exposure risks during replacement.
  • Intelligent control: PLC control is adopted, real-time monitoring of pressure difference, temperature, humidity, etc., in line with data integrity requirements.

 

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Key points of the operation process:

Preparation and sterilization: The materials are sent into the isolator through an interlocking airlock or transfer window, and then the interior of the isolator is sterilized with VHP (Volatile Hydrogen Peroxide) hydrogen peroxide vaporization.

Negative pressure operation: Operators perform the operation wearing sealed gloves or full-body suits, and all air passes through high-efficiency filtration.

Waste disposal: The waste generated during the operation is sealed inside the cabin and then discharged through a dedicated channel.

Cleaning and exhaust: After the operation, in-situ cleaning is carried out, and all exhaust air is treated by high-efficiency filtration to ensure it is harmless.

Application value:

Protect personnel safety: Prevent the medicines from harming the health of operators through respiratory tract, skin contact and other routes

Ensure environmental safety: Prevent the medicine dust from spreading to the surrounding environment and avoid cross-contamination

Guarantee medicine quality: Provide an environment with low microbial contamination risk to ensure that the medicine quality is not contaminated by external factors

Improve production efficiency: Through automated operations and a sealed environment, reduce human operational errors.

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From the core unit to the complete production line, Suzhou Pharma Machinery's isolation solutions have always been dedicated to addressing the key challenges in pharmaceutical production. This brand-new anti-cancer medicine isolator is precisely our latest example of our focus on innovation. If you would like to learn more about this equipment or any customized isolation solutions, please feel free to contact us at any time.

 

Suzhou Pharma Machinery Co.,Ltd.

2026/1/2

Tia

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