1. Inleiding

Aseptic isolation equipment is specially designed and manufactured according to the drug production quality management standard (GMP), and used in medicine health care products and require a higher level of environment protective barrier system, The pharmaceutical isolator system can maximize the pollution of prevention and control of the product, to protect the safety of the operator, to avoid being hurt by the toxic substances. Good pharmaceutical isolator manufacturers can provide perfect environmental control technology solutions for aseptic test, aseptic production and production protection of highly allergenic and toxic drugs.

Isolation equipment is either sealed or has a microbiological filtration system (HEPA) to provide air and is self-purifying. When sealed, use only the cleaned internal surface or use the quick transfer channel for material transfer.When opened, materials are only allowed to pass in and out through specific openings that have been designed and validated to eliminate contamination transfer. It can be used to isolate active mixtures during aseptic operations or for both sterilization treatments and isolation.

According to the use, isolator can be divided into aseptic inspection isolator, aseptic weighing isolation, aseptic feeding isolator, API isolator, etc.;

2. Performance feature

• The machine design, material, manufacture, assembly, debugging and so on met the new GMP pharmaceutical production specification requirements;
• Can choose stainless steel material, the machine structure and operation platform at the top of the whole closed structure design, the sterilization system, integrated control unit, in and out of the air system and air filtration unit, more beautiful and easy to clean and maintain;
• The machine body adopts smooth edges and corners, and the welding place is polished without burr. Internal arc Angle design, easy to clean;
• Each chamber according to the functional requirements for design, gloves with a standard size, no blind spot operation, special hull bust garment design may be adopted;
• Isolator equipment module design, uses the rat holes connection between each module, each part has obvious differential pressure gradient important areas to ensure that the amount of pressure difference relative to other areas for positive pressure;
• Isolator equipment can design according to the need for two kinds of single side or double side operation; The equipment has two design methods: split type and integrated type;
• Isolator can according to the function, increase the buffer tank shell, outgoing module or other chanbers were combined with the main hull, manufacture customized isolation system;
• Equipment exhaust device, remove excess hydrogen peroxide decomposition, avoid residues;
• VHP residue levels: < 1 PPM (residue level determined by the technological requirements);
• Chamber sealing: chamber leakage rate is not more than 5% within 10 minutes under pressure of 500 pa;
• Configurable gloves online leak detection system, can be used for online integrity detection for multiple gloves at the same time;
• Can configurate different shelves for different use;
• The isolator can be equipped with multiple cleaning water guns, the cleaning medium can be water (highly active drugs can use inactivated solvent) and compressed air;
• Configurable bag in/bag out (BIBO) system, safe replacement filters, ensure the safety of the people and the environment changing process;
• Configurable integrated VHP generator system without external VHP generator, better evaporated into gas, the hydrogen peroxide liquid to achieve better effect of sterilization, sterilization programmed temperature, accused of wet;
• Can be configured to monitor hydrogen peroxide concentration of gas, dust particles and planktonic bacteria port;
• Configurable RTP valve, achieve aseptic materials transfer;
• Equipment automatic hydrogen peroxide charging device can be configured, add fluid can be automatically according to the sterilization conditions;
• Configurable high and low concentration detection system, detection of hydrogen peroxide concentration in the process of sterilization;
• Configurable dehumidification system, make the air circulation through the dehumidifying device inside the isolator, would reduce the relative humidity inside the isolator, VHP sterilization efficiency;
• Functions of the control system: automatic control of gas pressure, automatic control of water and oxygen content, self-adaptive cleaning air circulation stepless variable speed, safety tips, fault diagnosis, data storage, password protection and other functions;

• Sterile isolator system in pharmaceutical industry can dock with the different equipment, accessories and integration, realize the various functions and technological requirements, customized design;