High Efficient Sterility Test Isolator Clean Environment Examination

high efficient clean environment examination sterility test isolator sterility test isolator

PVC sterility test isolator.pdf

The aseptic isolation system is specially designed and manufactured for medical and health care products according to the requirements of Good Manufacturing Practice (GMP).

And a barrier system that requires a higher level of environmental control protection. This system can prevent product contamination and protect the operator's safety and avoid toxic substances. Provides perfect environmental control technology solutions for sterility testing, aseptic processing and protection against highly sensitizing and toxic drug production. The PDA recommends that the following definitions of isolation systems be adopted by the healthcare industry worldwide:

The isolation system is sealed or has a microbial filtration system (HEPA) that provides air and is self-cleaning. When confined, use only the purified interior surface or use the fast transfer channel for material transfer. When opened, material is only allowed to pass in and out through a specific, designed and verified opening to remove the transfer of contamination. It can be used to isolate active mixtures during aseptic processing or for both sterilization and isolation

2,Parameter

• Hard hatch structure consisting of fully enclosed stainless steel and tempered glass;
• The cabin is welded integrally with 316L stainless steel, and all internal angles of the inner cavity are arc angles, which are convenient for
• Hard hatch structure consisting of fully enclosed stainless steel and tempered glass;
• The cabin is welded integrally with 316L stainless steel, and all internal angles of the inner cavity are arc angles, which are convenient for cleaning and sterilization operations;
• Completely unidirectional airflow mode provides an exceptional aseptic operating area;
• The airflow mode is a vertical unidirectional airflow that quickly eliminates biofouling during ventilation;
• The material door is inflated and sealed, with pneumatic locking and working state interlocking function;
• Integrated or independent hydrogen peroxide sterilization can effectively reduce bioactive substance pollution up to 106;
• Integrated YT-601B/YT-608B aseptic detection system to reduce the occupation of operating space;
• The system adopts Siemens PLC for control, integrating signals for acquisition, real-time data display, high and low voltage alarm, data record storage and printing functions;
• The hourly leakage rate is ≤0.5%, which guarantees the reliability of product quality and the safety of operators. The test is based on ISO14644-7.2004 and GB/T25915.7-2010 standards;

WHO WE ARE

Hangzhou WINTEAM Scientific Instrument Co., Ltd. is a key high-tech enterprise in Hangzhou China, which is a national high-tech enterprise integrating R&D, production, sales and service. The company's current main two departments:

Microbial departments

traffic departments.

WHAT WE DO

MICROBIAL DETECTION

• Sterility Test Canister
• Vacuum Filter Manifold
• Sterility Test Pump
• Sterility Test Isolator
• Hydrogen Peroxide Sterilization Equipment
• Microporous Membrane Filter
• Membrane Filtration Assembly
• Quality Control Strains
• Sterile Petri Dishes

TRAFFIC MACHINE

WINTEAM is a leader in the license plates production and systemic solutions provider in china. Our machine list is constantly expanded and currently includes

• License Plate Production Line
• Customized Automated production line for number plates
• Embossing press NFC Secure
• hot stamping NFC Secure
• Manual hot stamping/Automatic hot stamping
• Manual embossing press/Automatic embossing press
• materials and components for the production of license plates
• License plates shredders
• comprehensive systemic solutions in the field of vehicle registration
• Accessories and additional tool

Why choose WINTEAM

As a company that seize more than 90% china licence plants hot stamping market and half of Chinese sterility market, and about 200 professional stuffs to service to you,25 employees in R&D.

WINTEAM has abundant experience and enough Production capacity to Satisfy customer’s license plate & machinery demand.

Professional after-sales staff 24hours