ENVAIR eco safe ISO Compact CMR / TPE
- 4-filter system: CMR production
- 3-filter system: TPE / Sterile Production
ENVAIR eco safe Iso Compact is an Isolator system which mainly was designed for re-constitution of anti-neoplastic drugs. The system works in negative pressure thus offering triple protection: for operator, for product and for environment. Glove / Sleeve combinations integrated in the front visor offer the physical separation from product and operator thus offering perfect personnel protection. ENVAIR eco safe Iso Compact may be used as well for handling pathogens, no matter of which group as per EN 12469:2000, as well as for any processes which require handling of cytotoxics or other dangerous chemical agents. ENVAIR eco safe Iso Compact can be used manifold in clinical oncology centres, for preparation of medication and for any application requiring a high grade of personnel protection. In detail the unit is qualified for the following applications:
- Preparation of anti-neoplastic chemo-therapy
- Manipulation of cytotoxic and cytostatic medication
- Manipulation aetiological agents with proved pathogenity to humans and animals
- Handling of pathogenic mixtures of high concentration and mutagen agents
- Onkogenic viruses
- Microbiology, Virology and Cell cultures
- Transformed DNA applications
Ambient air is sucked into the closed Isolator system from the top. The air is filtered by the suction HEPA filter and led downwards as laminar flow before it is filtered again by a second HEPA filter. Since the system works in negative pressure, the air is re-circulated and again filtered by the main HEPA filter which is placed underneath the work surface (third filtering station). This air is partly delivered back to the main work zone and partly delivered back to the ambience, after it has been filtered again by the exhaust air HEPA filter (fourth filtering station).
The housing is made of cold-rolled epoxy-painted steel with Alesta® Dupont anti-microbial coating. The inner surfaces are manufactured of stainless steel AISI 304, the work surface of the work chamber as well as of the transfer chamber are made of stainless steel AISI 316 with Scotch-Brite finish. All edges are smoothly rounded with 3 mm radius. The entire Isolator may as well be delivered complete of stainless steel AISI 304 or stainless steel AISI 316 with Scotch-Brite finish.
The front windows of Isolator and Transfer Hatch are made of 8 mm thick double safety glass, glare-free - the left and right hand side windows are made of 6 mm thick tempered glass. The front window of the main chamber can be opened completely for cleaning and maintenance purposes, with the help of two attached handles. Two gas struts hold the window in open position. Tightness of the front window is guaranteed by tested gaskets and are pressed against the frame by screws.
The Isolator is fitted with 300 mm round PTEG openings with O-ring system, to hold sleeves.
The transfer hatch is electro-magnetically locked. The inner and outer door lock is staggered. Opening the inner door is only possible after an automatically staggered rinsing process. The inner door is of PETG material, opening is possible by an up/down sliding system.
The operative airflow speed is set ex works to 0,40 m/s in both, main working zone and transfer hatch. Reduced air speed at 0,25 m/s is also available. Alternative settings ex works are available upon request.
The unit works with an operative pressure of -100 Pa (set in our works).
|Standards||EN 1822, EN12469, EN61010-1, ISO 14644.1||EN 1822, EN12469, EN61010-1, ISO 14644.1||EN 1822, EN12469, EN61010-1, ISO 14644.1|
|Outer dimensions||1350 x 2345 x 860||1655 x 2345 x 860||1960 x 2345 x 860|
|Inner dimensions||850 x 740 x 580||1155 x 740 x 580||1460 x 740 x 580|
|Transfer hatch||300 x 300 x 400||300 x 300 x 400||300 x 300 x 400|
|Pressure||-100 Pa||-100 Pa||-100 Pa|
|Electr. connected values||220-240V,AC, 50Hz,1ø, 600 W||220-240V,AC, 50Hz,1ø, 660 W||220-240V,AC, 50Hz,1ø 660 W|