TS-ROTO TYPE

cGMP TERMINAL STERILIZERS WITH LOAD-ROTATING SYSTEM

TS-ROTO TYPE

cGMP TERMINAL STERILIZERS WITH LOAD-ROTATING SYSTEM

TS ROTO autoclaves are specifically designed for the terminal sterilization of lipid-based liquids (with varying specific weights) contained in sealed containers such as plastic bags, glass bottles, BFS containers, syringes, vials, etc. They feature automatic pressure compensation based on the temperature difference (ΔT) measured by an RTD probe inserted into a “sample” container. This prevents deformation, damage, or discoloration of plastic containers. The load rotation system avoids stratification or precipitation of heavier liquid phases within the containers.

LIQUIDS

MIXED AIR + STEAM or OVERHEATED WATER

105°C – 121°C

Process features
Additional information

- 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.
- Terminal sterilization using a mixture of Air + Steam.
- A built-in ventilation system that mixes the clean steam and air together, thus creating the sterilization medium.

This processing method is recommended for complex plastic or glass containers, such as pre-filled syringes or vials in which condensate may form and become problematic for the finished product. The system ensures optimum heat distribution throughout the entire sterilization phase (temperature deviation less than ± 1°C). These autoclaves also feature an improved drying process, thanks to the ventilation system that prepares the unloaded product for labelling and packaging.

Terminal sterilization using overheated Water.

A high-flow water recirculation system, thanks to the centrifugal pumps and “double-head multitube” heat exchangers which allow a “water” medium (WFI or PW) to be used as a means of transferring heat to warm up, sterilize and cool down the load. The system ensures optimum heat distribution throughout the entire sterilization phase (temperature deviation less than ± 1°C). This process method includes faster cycles but the treated product comes out still damp. Nevertheless, it is still the preferred method in most cases, due to its simplicity, cost-effectiveness and ease of validation.

Circular cross-section sterilization chamber with square or rectangular hatches (doors).
For the air + steam mixture process, a flat/circular jacket surrounds the chamber for a quick and uniform load heating/cooling.
For the overheated water process, single-wall chamber (without jacket).
The chamber is placed on a base designed to evenly distribute the weight on the floor.
Internal structure for rotation of the load with electrical-mechanical drive.
The bottom of the chamber converges towards the drain sump to facilitate the condensate and water drain.
Two 2” 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.
Both doors (loading and unloading side) have been designed to be connected to the walls of the cleanrooms (“Bio-seal” interface).