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Customized Medical Device Manufacturing Isolator

  • After Warranty Service: Video technical support, Online support

  • Certification: CE ISO GMP

  • Name: VHP Isolator

  • Application: Cleanroom, lab, dust-free room

  • Compressed Air Volume: 0.5MPa

  • Power V/Kw: AC220 /3.5

  • Transfer Cabin Size (W*D*H)mm: 600*680*700

  • Operating Cabin Size(W*D*H)mm: 1195*680*700

  • Outer Dimension(W*D*H)mm: 1600*880*2250

  • Cabin Material: External Full 304 Stainless Steel


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Limit Discounts

Limit Discounts


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Description

Description


The Customized Medical Device Manufacturing Isolator is designed to provide a sterile and controlled environment for the safe and efficient manufacturing of medical devices. This isolator ensures full compliance with GMP standards, allowing manufacturers to meet stringent regulatory requirements while minimizing contamination risks. Tailored to the specific needs of medical device production, this isolator offers high flexibility, precision control, and seamless integration with automated processes.

With advanced air filtration systems, robust material handling solutions, and customizable options for size, access ports, and automation, this isolator is ideal for creating a safe, controlled production environment for sensitive medical devices. Whether producing surgical instruments, implants, or diagnostic devices, the isolator guarantees protection from contaminants while ensuring product quality and operator safety.


Applications:

  • Surgical Instrument Manufacturing: Ensures contamination-free production and sterilization of surgical tools.
  • Implantable Device Production: Provides a controlled environment for manufacturing and assembling medical implants.
  • Diagnostic Device Assembly: Supports precise, sterile conditions for producing diagnostic devices, such as catheters and test kits.
  • Sterile Packaging: Ensures a contamination-free environment for packaging sterile medical devices.
  • Customized Medical Device Production: Tailored solutions for manufacturing unique or complex medical devices requiring specialized handling and environmental control.


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Key Features:

  • Sterile Environment: Ensures contamination-free production for medical devices.
  • Customizable Design: Configurable size, number of access points, and process-specific integrations.
  • Advanced Filtration: Equipped with HEPA/ULPA filters for superior air quality control.
  • GMP Compliant: Meets global regulatory standards for medical device manufacturing.
  • Ergonomic Access: User-friendly design with glove ports and easy access for maintenance and monitoring.


Technical Parameters


MaterialExternal all 304 stainless steel, internal chamber 316L stainless steel
Cleanliness levelClass A
Wind speed0.45m/s ± 20%
Leakage rate≤ 0.5% VOL/h (below 100pa)
Exhaust volume≥ 300m ³/ H
Pressure control range100pa~+100pa
Sterilization efficiency6lg
VHP residual removal efficiency≤ 1PPM
Control methodManual or automatic
Noise≤ 68dB (A)
illumination≥ 350LUX

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Installation

Installation


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Get in touch with us
Just leave your email or phone number in the contact form so we can send you a free quote for our wide range of designs!  We have more than 16 years of experience in cleanroom turnkey projects , with business all over the world. We adhere to the principle of customer first, serve every cooperative customer attentively, and focus on the standard delivery of each cleanroom project.
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Telephone: +86-18241958031/
+86-18913598640
Fax: 86-512-65488640
Whatsapp/Wechat: 008618241958031

Notice:
We hereby declare that our company's only legal contact is through the the above email, Any other similar suffix is a scammer email. 
Address: NO.188 xiangwei road, near junction of xiangwei road and chengyang road (the second floor of south building inside of haiji feiyue) Xiangcheng district, Suzhou city, Jiangsu province, China
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