Audited Supplier
GMP Aseptic Sterile Isolator for clean room Lab Testing VHP sterilization system
Aseptic isolator M-ISOLATOR-P
This machine is mainly used for aseptic production and testing. Isolate personnel and materials during the operation process to avoid product contamination or cross contamination. Ensure the authenticity of test results during aseptic and microbiological examinations, while protecting the health and safety of operators. VHP sterilization system can be configured according to requirements, and customized to non-standard sizes according to customer needs. The main materials of the cabin are high-quality stainless steel and tempered glass, with a hard cabin structure that meets Class A standards statically.
| Model | M-ISOLATOR-P |
| Operating port size | Dia.240mm |
| Airflow mode | Vertical unidirectional flow |
| Airflow speed | -100Pa ~ -20Pa |
| Purification level inside the cabin | Static A-level |
Advantages:
- The inner cavity adopts laminar (turbulent) air supply, and the air manifold is professionally designed to ensure purification level;
- Real time monitoring of internal cavity pressure, temperature, and wind speed, and automatic control and adjustment;
- It can integrate VHP sterilization program, and the microbial killing rate can reach more than 6 logarithmic levels (Log 6);
- The sealing level of the isolator is strictly tested according to the ISO14644-2 standard;
- Waste can be quickly transported out of the work area through RTP and alpha beta valves to ensure a clean internal environment of the isolator (optional);
- PLC control, touch screen operation, key operation interlock control, effectively preventing misoperation;
- Real time monitoring of key parameters, storing data and charts for easy export and printing;
- Integrated dust particle online detection system, planktonic bacteria online sampling system, and hydrogen peroxide concentration online detection system as needed;
- Can be equipped with an online glove leak detector.
Why Choose Us?
- Well-experienced. Miran was founded in 2010.Focused on the pharmaceutical and chemical industry for over a decade
- Strong processing ability. We have independent research and development, production and manufacturing base, and more than 20 advanced processing equipment.
- Emphasis on R&D. We focuses on product research and innovation, with over ten R&D personnel and more than thirty patent certificates
- Complete verification.The verification system is complete, with a dedicated verification team responsible, complete verification materials, and a comprehensive after-sales service system
- Professional.Focusing on the pharmaceutical industry, familiar with pharmaceutical production processes, understanding and deepening the concept of verification system,
FAQ:
Q1: Are you a manufacturer?
Ans: *1.Yes, we have been in manufacturing and providing excellent cleanroom and solid preparation front-end processing system for customers more than 10 years.
*2.Our own production plants and a wide network of suppliers who are strictly selected, are totally qualified for ISO Quality Management System.
Q2: Do you inspect the finished products?
Ans:Yes, we will do inspection according to ISO standard and ruled by our QC staff.
Q3: Do you do OEM or ODM?
A:Yes, we do OEM and ODM. Customer's LOGO can be printed on our products
Q4: How long is the delivery time?
Ans: Normally 7days if we have the sample on hand. If customized one, about 60days.
Q5: How long is the warranty period?
Ans: One year after shipment.
