Predefined and custom programmes for all needs. The machine process is developed by our Automation department in compliance with current regulations/standards and the type of product being sterilized. Sterilization chamber pressure or vacuum tests, Bowie & Dick tests, Helix tests, automatic filter breaker test with integrity tests; solid component and porous load programme; programme for liquids in ventilated containers; programme for liquids in sealed containers; programme for liquids in syringes; sensitive/fragile product (e.g. filter cartridges) programme; rubber cap programme; decontamination cycle with chamber condensate sterilization and drain filtration, in compliance with BSL3 and BSL4, etc. The steam is injected into the sterilization chamber via a PID-controlled automatic modulating valve and the condensate generated is continuously evacuated via the drain to ensure excellent heat distribution throughout the sterilization phases (temperature deviation less than ± 0.4°C).
RSA TYPE
cGMP SATURATED STEAM AUTOCLAVES
RSA TYPE
cGMP SATURATED STEAM AUTOCLAVES
RSA autoclaves are designed to sterilize heat-resistant and moisture-stable materials with clean saturated steam.
These include metal parts, plastic or rubber parts, liquids in ventilated (open) or sealed (hermetic) containers, filter cartridges and clothing.
POROUS, NON-POROUS AND LIQUIDS
SATURATED STEAM
121°C – 134°C
- Circular cross-section sterilization chamber with square or rectangular hatches (doors).
- A dimpled jacket surrounds the chamber for a quick and uniform load heating/cooling.
- The chamber is composed of one fully welded vessel with rounded corners to ensure excellent hygiene and facilitate the cleaning of inner surfaces.
- Mechanical construction, heat-resistant over 140 °C.
- Reinforcements are welded onto the outside of the jacket to ensure stable operating conditions.
- The chamber is placed on a base that has been designed specifically to evenly distribute the weight on the floor.
- The loading cart-insertion and removal guides are placed on the bottom of the chamber; they are also height-adjustable.
- Two 1.5” tri-clamp ferrules are welded to the chamber for validation purposes (temperature uniformity mapping and pressure tests).
- All of the chamber’s internal surfaces are mechanically polished and then undergo chemical degreasing, pickling and passivation treatments. Surface finish ≤ 0.35 micron.
- The bottom of the chamber converges towards the drain sump to facilitate the disposal of condensation.
- The chamber can be installed at floor level or in a pit (depending on the size).
- Both doors (loading and unloading side) have been designed to be connected to the walls of the cleanrooms (“Bio-seal” interface).
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