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The Nordic Labtech n-Safe Isolator Cyto is a negative pressure isolator for preparing cytotoxic drugs and pharmaceutical preparations under aseptic Grade A conditions. The fully enclosed work zone with glove ports protects both the operator and the product against hazardous substances. With unidirectional airflow, HEPA H14 filtration, two transfer chambers and an automatic leak test, the isolator complies with EN ISO 14644-7 and GMP Annex 1. Available in 1200, 1500 and 1800 mm widths with an internal or external exhaust fan. Poly Temp supplies the n-Safe Isolator Cyto on a quotation basis.
The n-Safe Isolator Cyto by Nordic Labtech is an advanced negative pressure isolator for preparing cytotoxic drugs and pharmaceutical preparations under aseptic Grade A conditions. The fully enclosed work zone with glove ports offers maximum protection of both the operator and the product when handling hazardous substances. Because the isolator operates under negative pressure, harmful aerosols stay inside the work zone and cross contamination is prevented. The Cyto is developed for hospital pharmacies, cytotoxic compounding units and pharmaceutical production.
The work zone maintains a unidirectional airflow of 0.45 m/s with a tolerance of plus or minus 20 percent and around 1300 air changes per hour, resulting in a stable Grade A environment. Air handling uses HEPA H14 filtration according to EN 1822, with an efficiency of 99.999 percent at 0.3 micron. The system includes the main downflow filter, prefilters and filtration in the transfer chambers. The H14 cartridge prefilters feature a safe-change system with double sealing, so saturated filters are removed safely and without exposure.
The isolator has two transfer chambers (airlocks) with programmable interlock times, so material moves in and out of the work zone under controlled conditions. The inner doors are electrically driven and operated with a foot switch, which means no compressed air is required and the hands remain free. A built-in automatic pressure decay leak test checks the integrity of the isolator. The isolator complies with EN ISO 14644-7 and GMP Annex 1 and is available with an internal or external exhaust fan.
The Cyto is fitted with an electrically height adjustable base with a working height of 750 to 1050 mm and a large front window with a gas spring. The glove ports have a diameter of 300 mm. Operation runs through a fully digital touchscreen. The dimmable LED lighting is adjustable from 0 to 2000 Lux with a colour rendering index of RA95 or higher. The work surfaces are made of segmented stainless steel and the interior is white powder coated, for good cleanability and a clear view of the process. The isolator is available in three widths: 1200, 1500 and 1800 mm, with 2, 3 and 4 glove ports respectively and a weight of 540, 580 and 630 kg.
The n-Safe Isolator Cyto is subject to export control and is classified under classification code 2B352.f.2. An export licence is required for export from the European Union. Poly Temp is glad to advise you on the applicable requirements for delivery outside the EU.
| Model | Cyto 1200 | Cyto 1500 | Cyto 1800 |
|---|---|---|---|
| Width | 1200 mm | 1500 mm | 1800 mm |
| Glove ports | 2 | 3 | 4 |
| Weight | 540 kg | 580 kg | 630 kg |
| Exhaust fan | internal or external | internal or external | internal or external |
| Product type | Negative pressure isolator for cytotoxic and pharmaceutical preparation |
|---|---|
| Brand / series | Nordic Labtech n-Safe Isolator Cyto |
| Cleanliness class | Grade A (aseptic) |
| Airflow | Unidirectional, 0.45 m/s (plus or minus 20 percent) |
| Air changes | Around 1300 per hour |
| Filtration | HEPA H14 according to EN 1822, 99.999 percent at 0.3 micron (main downflow, prefilters, transfer chambers) |
| Prefilters | H14 cartridge with safe-change (double sealing) |
| Transfer chambers | Two, with programmable interlock times |
| Leak test | Built-in automatic pressure decay leak test |
| Inner doors | Electrically driven, operated by foot switch (no compressed air) |
| Base | Electrically height adjustable, working height 750 to 1050 mm |
| Front window | Large window with gas spring |
| Glove ports | Diameter 300 mm |
| Control | Fully digital touchscreen |
| Lighting | Dimmable LED 0 to 2000 Lux, CRI greater than or equal to RA95 |
| Work surfaces | Segmented stainless steel |
| Interior | White powder coated |
| Exhaust fan | Internal or external (of choice) |
| Standards | EN ISO 14644-7 and GMP Annex 1 |
| Export control | Classification code 2B352.f.2.; export licence required for export from the EU |
| Configuration | Variable product, price on quotation |
The n-Safe Isolator Cyto is a negative pressure isolator for preparing cytotoxic drugs and pharmaceutical preparations under aseptic Grade A conditions. It is used in hospital pharmacies, cytotoxic compounding units and pharmaceutical production, where both the operator and the product must be protected against hazardous substances.
The negative pressure keeps harmful aerosols and vapours inside the enclosed work zone. This protects the operator against exposure to cytotoxic substances and prevents cross contamination of the environment, while the product remains aseptic.
The isolator uses HEPA H14 filtration according to EN 1822, with an efficiency of 99.999 percent at 0.3 micron. Filtration covers the main downflow filter, prefilters and filters in the transfer chambers. The H14 cartridge prefilters have a safe-change system with double sealing for safe replacement.
The isolator has two transfer chambers with programmable interlock times for controlled entry and exit of material. The inner doors are electrically driven and operated with a foot switch, so no compressed air is required and the hands remain free.
The n-Safe Isolator Cyto complies with EN ISO 14644-7 and GMP Annex 1 and delivers an aseptic Grade A environment with a unidirectional airflow of 0.45 m/s and around 1300 air changes per hour. A built-in automatic pressure decay leak test checks the integrity.
Yes. The n-Safe Isolator Cyto is subject to export control with classification code 2B352.f.2. An export licence is required for export from the European Union. Poly Temp advises you on the requirements for delivery outside the EU and supplies the isolator on a quotation basis.
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