Modular Clean Room

Isolator

Keywords: isolator in sterile area, isolator sterile manufacturing, sterile compounding isolator, Sterility testing isolator

The isolator adopts the ISOLATOR safety level with environmental control meeting Class A standards. It integrates seamlessly into Class D or CNC environment laboratories, eliminating the need for complex B-level zone gowning procedures. Operators are completely isolated from test samples, eliminating cross-contamination risks and fundamentally resolving false positives to ensure drug release. It also significantly reduces environmental operating costs.Integrated with a sterile pass-through window and hydrogen peroxide sterilization/decontamination technology, it enables efficient, rapid sterilization of samples prior to testing, further mitigating risks.The equipment accommodates diverse batch sizes and process requirements.

Features:

Modular design, configuration, loading capacity, and structural combinations can be flexibly selected based on customer testing batch sizes.
Features a seated operation mode to reduce work fatigue and enhance operational accuracy.
Supports handling of toxic materials with a system enabling safe filter replacement.
Class 100 Vertical Laminar Flow
Adjustable positive/negative pressure

Enqury Now

Isolators are mainly used in the pharmaceutical industry to provide a physical barrier to protect the sterile environment and personnel safety. It consists of an operating cabin and a transfer cabin, with a positive pressure fully enclosed design. The airflow pattern is similar to that of a biological safety cabinet, but the pressure is opposite. It supports processes such as filling, weighing, and batching, and can be customized in size and equipped with an optional VHP sterilization system.

Aseptic isolators are used for sterile production and testing, meet Class A clean standards, use stainless steel/tempered glass hard cabins, and have laminar or turbulent flow designs. The closed isolator completely isolates personnel and processes to prevent contamination, and is suitable for sterile inspections, microbial testing, etc. Operations are performed using gloves, and materials enter and exit the transfer cabin.

Sterility Testing Isolator (Rigid Chamber) Key Technical Parameters:

Model	HSM-lL
Power Supply	AC220V+22V/50Hz
Power Consumption	3KW
Dimensions	253012502290mm (LWH)
Noise Level	≤70dB(A)
Pressure Differential	0~80Pa (adjustable)
Cleanliness Level	Class A (static)
Sterilization Rate SAL	6Log

Contact us at boben Modular Cleanroom Manufacturer. We will provide a detailed, customized sterile isolator solution and technical quotation tailored to your specific process requirements (such as filling speed, material characteristics, required VHP cycle time, etc.), aligning with your budget and standards.

What are the application scenarios of sterile isolators?

Vaccine aseptic filling

Requirement:Ensure the sterility of the mRNA vaccine filling process in compliance with FDA/EMA regulations.
Solution:Fully automated isolator with integrated VHP sterilization (log6 microbial kill). Equipped with Class A laminar flow (ISO Class 5) and online particle monitoring system.
Result:Achieved zero-contamination batch production and passed FDA on-site audit.Filling efficiency increased by 30% (compared to traditional RABS system).

Cell therapy product preparation

Requirement:Sterility and cross-contamination prevention and control of CAR-T cell processing.
Solution:Small biosafety isolator (BSL-2 level) with integrated CO₂ culture module.Single-person mobile design saves clean room space.
Result:The contamination rate of cell products has been reduced from 5% to 0.2%.50 clinical-grade cell preparations have been successfully completed.

Choose Boben, choose expertise and trust.

As a globally renowned modular cleanroom manufacturer, we specialize in delivering high-standard clean solutions. Our products are exported to five continents and successfully deployed by numerous internationally renowned pharmaceutical companies and research institutions. We provide not just equipment, but a comprehensive sterile process assurance system.

By choosing us, you gain:

International Project Management Team: Possessing extensive export experience, we are well-versed in international logistics, customs clearance, and destination installation requirements.
Localized Service and Support: Remote technical guidance is available, with professional engineers dispatched for on-site installation and training when necessary.
Long-Term Partnership Commitment: We provide reliable spare parts supply and ongoing technical consultation services.

Act Now:Customize Your Rapid Clean Space!

Don’t let lengthy lead times slow down your production schedule.
Contact our cleanroom experts for a free design consultation and customized quote to kickstart your fast-track production journey.

FAQ

A: Boben has 14 years of professional experience in R&D, production and sales of modular cleanrooms. As a seasoned foreign trade manufacturer, our business covers Southeast Asia, the Middle East, Europe, Africa and other regions. We deeply understand the local industry standards, certification requirements and market needs of different countries, and have served hundreds of B-end customers including electronics, pharmaceuticals, food processing and laboratories overseas.

A: Our modular cleanrooms cover ISO 1 to ISO 9 (equivalent to Class 100 to Class 100,000) cleanroom classes. They are widely applicable to electronics & semiconductor manufacturing, biopharmaceuticals, medical devices, food sterile processing, precision laboratory research and other scenarios. Each set of products is designed according to the unique process requirements of different industries, such as temperature/humidity control, anti-static design, and microbial pollution prevention.

A: Yes, customization is our core advantage! Based on 14 years of technical accumulation, we can tailor solutions according to your actual needs: ① Cleanroom class (ISO 1-9) and space size; ② Core configurations (HEPA filter system, air circulation mode, constant temperature & humidity system, intelligent monitoring); ③ Material selection (stainless steel, color steel plate, aluminum honeycomb panel, etc.); ④ Compliance with local standards (such as FDA, GMP, CE, etc.). We will provide one-stop customized services from scheme design to final delivery.

A: Absolutely! All our products strictly comply with international standards such as ISO 14644 (cleanroom classification) and ISO 14698 (biological contamination control). We have passed multiple international certifications, and the delivered cleanrooms can smoothly pass third-party testing and certification required by target markets (such as FDA for the US, GMP for the EU, and local certification standards in Southeast Asia/Middle East). We will provide complete technical documents and test reports to assist you in customs clearance and market access.

A: The production cycle is 2-4 weeks for standard configurations and 4-6 weeks for customized solutions (faster than the industry average). For overseas transportation, we cooperate with well-known logistics companies to provide sea/air shipping options, and professionally package modules to avoid damage during transportation. On-site installation is simple and fast—we provide detailed installation drawings, video guidance, and can dispatch technical teams to overseas sites if required. The entire installation process can be completed in 1-2 weeks, helping you put into production quickly.

A: We provide global after-sales service with no worries: ① 1-year warranty for core components (HEPA filters, control systems, etc.), and lifelong maintenance services; ② 24/7 online technical support (via email, phone, video call) to solve problems in a timely manner; ③ Spare parts supply guarantee—we have cooperative warehouses in key regions to ensure fast delivery of spare parts; ④ Regular follow-up visits to understand the operation status of cleanrooms and provide optimization suggestions. With rich foreign trade service experience, we can communicate smoothly in multiple languages and solve your after-sales concerns efficiently.