The Best Sterillity Testing Isolator Machine Negative Pressure Isolator

• Customization: Available
• Theory: Autoclave
• Type: Pressure Steam Sterilization Equipments
• Model NO.: SPIS-1
• Certification: CE, FDA, ISO13485
• Electric Tension: 220V
• LCD Display: With LCD Display
• Sterilization Information Recording and Printing: Sterilization Information Recording and Printing
• Material: Stainless Steel
• Model Number: Sterility Test Isolator
• Machinery Test Report: Provided
• Warranty of Core Components: 1 Year
• Core Component: PLC, Motor, Touch Screen
• Control System: PLC Control System
• Transport Package: Standard Package
• Specification: 440*350*390mm
• Trademark: Forever Medical
• Origin: China
• Production Capacity: 3000pieces/Month

Product Description

SPIS-1 isolator 

 

 

Main description

The use of weighing, proportioning and dispensing isolator.

The purpose of this isolator is to ensure the operator's safety giving the maximum protection during all handling operations, ensuring the separation between the external glove box environment. The operator works while standing and is completely isolated from the substance being manipulated.

 

Designed to provide containment(OEL to 0.5ugm/m3) for the purpose of potent products, this isolator is a double chamber unit, one for the drum loading and the other for the dispensing operators.  The isolator contains a weigh balance has a gull-wing door, glove ports and a wash in place system. The isolator operates at a negative pressure  with and in the case of a containment breach the system will alarm and provide air in rush protection.

 

The design has been ergonomically tested to ensure that the intended operations can be easily performed and is fully GMP compliant.

 

Main features

1. Fully PLC controlled

2. Software GAMP5 compliant

3. Friendly operator interface

4. Sliding tray

5. Pass through door for communication with adjoining chamber

6. 190mm glove flanges with gloves

7. 270mm glove flanges with gloves

8. Continuous film port diameter 380mm

9. H+T sensor for temperature and humidity internal monitoring

10. Magnetic manometers for the internal pressure control

11. Inverter for ventilation fan speed control

12. Automatic valves for air flow interception JUMO manometers

13. JUMO manometers to monitor inlet and outlet filters obstruction

14. Advance PUSH-PUSH system, bag in bag out system , RTP ,α/βvalve  

 

Technical parameters

Item	API weighing sampling isolator
Production capacity	8hours*7days
Motor power	4-0.8kw
Total power	5-15kw/h
Power supply	380V±38V/50±1Hz/60Hz
Dimension	2800×855×2800
Material	SS316L/304
Weight	700kg
Noise	≤70db(A)
OEL	OEB5
Air speed	0.36-0.54m/s
Laminar flow	Vertical unidirectional flow/Turbulent flow
Tem/humidity online monitoring	Yes
Working pressure	+45~-150Pa
Cleanliness level	A class environment
Structure mode	Modular + Expansion port
Leakage rate	≤0.25%Vol/h
Illumination	≥500Lux
Inner cavity material	AISI316L
Outside material	AISI304
H2O2 sterilizing time	≤90min
Sterilization effect	6LOG
Sterilization method	Hydrogen peroxide vapor
Sterilization concentration	>300PPM
Standard for residual VHP concentration after sterilization	≤1PPM
Classification during equipment operation	A LEVEL