n-Safe Isolator Steril aseptic isolator

n-Safe Isolator Steril: positive pressure isolator for aseptic work

The n-Safe Isolator Steril from Nordic Labtech is a positive pressure isolator developed specifically for the aseptic preparation and handling of sterile pharmaceutical products under Grade A conditions. This aseptic isolator operates under positive pressure, so the fully enclosed work area is maximally protected against contamination from the surrounding environment. For pharmacies, hospital pharmacies and pharmaceutical production, this sterility isolator offers a reliable solution in which product protection and sterility are the central priorities.

Grade A conditions and unidirectional airflow

Within the work area, the pharmaceutical isolator maintains a unidirectional airflow of 0.45 m/s with a tolerance of plus or minus 20 percent. This results in approximately 2300 air changes per hour and a constant Grade A environment. The HEPA H14 filtration is applied to both the downflow and the transfer hatches (supply and exhaust) and complies with EN 1822 with a retention of 99.999 percent at 0.3 micron. In this way the aseptic work environment remains guaranteed under all conditions.

Safe transfer and integrated leak test

The GMP isolator is equipped with two transfer chambers with a programmable interlock, so that materials enter and leave the work area safely without breaching sterility. For validation, the isolator features sealing lids on the supply filters and a built-in automatic pressure decay leak test. These functions make periodic integrity testing simple and reproducible, fully in line with the requirements for aseptic work.

Ergonomics and operation

The electrically driven inner doors are operated by a foot switch, without compressed air, which creates a quiet and clean work environment. The electrically adjustable base offers a working height of 750 to 1050 mm, so every operator can work ergonomically. The large front window with gas springs and the glove ports with a diameter of 300 mm provide comfortable access. All functions are controlled through a fully digital touchscreen. The dimmable LED lighting of 0 to 2000 Lux with a colour rendering of at least RA95 guarantees optimal visibility of the work.

Construction and standards

The work surfaces are made of segmented stainless steel and the interior is white powder coated for easy cleaning and visual control. The n-Safe Isolator Steril complies with EN ISO 14644-7 and GMP Annex 1. The positive pressure isolator is available in three sizes (1200, 1500 and 1800), with 2, 3 and 4 glove ports respectively and an internal exhaust fan. This sterility isolator therefore combines validation, ergonomics and compliance in a robust system for aseptic isolator work.