GMP Pharmarceutical Automatic Aseptic Filling Sterile Isolator

• Customization: Available
• Certification: CE, GMP, ISO, GMP
• Condition: New
• Model NO.: SGL-20
• Customized: Customized
• Voltage: 380V
• Warranty: 1 Year
• Type: Preparation Machinery
• Finished Dosage Form: Capsule
• Precision: High Precision
• Computerized: Computerized
• Transport Package: Wooden Case Packing
• Specification: 700kg
• Trademark: Medigrade
• Origin: Shanghai, China
• HS Code: 8422303090
• Production Capacity: 100 Sets/Year

Product Description

Sterility Test Isolator

It is used for sterile testing , weighing, dispensing and transferring for the sterile substance with toxicity to ensure the reliable sterile environment.



Main features

Sterile test isolator is a sealing system, through fan filter unit (high efficiency filter , HEPA)to realize the air safe exchange and achieve the online monitoring of  particles and microorganisms in the inner environment. Use quickly transfer channels or air brakes to aseptic transfer of materials and ensure the protection between the operator and the drug, and can handle 1-6 operators at the same time.

Equipped with Millipore sterility tester, it saves a lot of time for checking. It has H2O2 pass box, which is suitable for multiple batch sample testing.

Fully meet the requirements of USP/EP/CHP sterility testing regulations, stable performance, ensure the quality of drug testing.

Parameters of samples are monitored and recorded, they can be either directly sent to a printer(option) or stored on a remote PC.

Technical parameters

Item	Isolator (soft)	Isolator(stainless steel)	API sampling isolator
Production capacity	8-10batches/day	8-10batches/day	8hours*7days
Motor power	5-7kw	5-7kw	4-0.8kw
Total power	0.4-0.8kw/h	4-0.8kw/h	5-15kw/h
Power supply	380V±38V/50±1Hz/60Hz
Dimension	3019×1000×2390	2508×1100×2500	2800×855×2800
Material	PVC,SS316L, cover ss304	SS316L/304	SS316L/304
Weight	400kg	600kg	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	PVC	AISI316L	AISI316L
Outside material	PVC	AISI304	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

If you are interested in this, please contact me: Nana Zhang
Shanghai Medigrade Industry Co.,Ltd
Waigaoqiao Free Trade Zone, Shanghai,China. 200137
 
 
 

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