GMP-Certified Closed System Flexible Isolator for Sterile Pharmaceutical Operations

• Customization: Available
• Certification: GS, RoHS, CE, ISO9001
• Noise: Less Than 75
• Model NO.: M-ISLT-SC
• Application: Industrial
• Control Mode: Touch
• Usage: Fragrance, Dust Removal, Smoke Removal, Adding Negative Ion, Humidification, Formaldehyde Formaldehyde, Adding Oxygen, Sterilization
• Inlet Air Speed: 0.45m/S±20%
• Rated Power: 4.2kw
• Indoor Illuminance: High Than 500 Lux
• Control Operation: PLC
• Illumination: More Than 300 Lux
• Airflow Mode: Turbulence
• Transport Package: Wooden Case
• Specification: 2400*2100*2450 mm
• Trademark: Miran
• Origin: China

Product Description

GMP-Certified Closed System Flexible Isolator for Sterile Pharmaceutical Operations

Product Description

The flexible isolator is a flexible, closed membrane system suitable for micronization, dispensing, metering, filling, sampling, weighing operations and a variety of special applications. The equipment provides isolation protection between the operator and the product, and allows safe and contamination-free operation of small amounts of highly active or hazardous substances through closed operation with gloves. It is also suitable for sterile and biohazard pharmaceutical production applications; its design is based on specific applications and requirements. Determined by the realized process, it meets the production needs of multiple forms of pharmaceuticals without complex cleaning procedures and cleaning verification steps. It is suitable for applications that require frequent product changes. Millon not only provides standard flexible isolation solutions, but also provides customers with customized solutions, providing full-scale ergonomic operation simulation to meet the applicability of customers' specific process tasks in pharmaceutical production.
 

Product Parameters

Model	M-ISLT-SC
External dimensions	Customized
Noise	≤75 dB
Illuminance	≥300 LUX
Airflow mode	turbulence
Operating cabin pressure	-100Pa ~ -20Pa
Power supply	AC220V,50Hz
Protection level	OEB 4
Cabin airtightness	Meet ISO10648-2 standard requirements
HEPA filter	PUSH-PUSH filter

 

 

Detailed Photos

Advantages:

• Positive and negative pressure protects operators and products;
• Process control can adapt to OEL requirements, up to 1ug/m3 (OEB5);
• Low investment and maintenance costs;
• Extremely low cleaning and verification costs;
• Short replacement time and strong flexibility;
• Can be adapted to different types of cabinets and applications.

 

Certifications

Production & Processing

 

Company Profile

 

Exhibitions

 

 

Packaging & Shipping

 

 

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.