Description
Each LyoGamma is configured as a compact mono-bloc unit that can be installed through the wall of the sterile room while offering easy maintenance access to all elements and optimising the total space necessary.
The unit has the following basic features:
- Covers freeze drying shelf areas from 0.5 m2 to 2 m2.
- Horizontal cylindrical chamber, manufactured in AISI 316 L stainless steel.
- Vertical cylindrical external condenser manufactured in AISI 316L stainless steel, located underneath the chamber.
- The inside of the chamber-condenser group is polished and it has a self-draining design to promote effective cleaning and sterilisation.
- The door is constructed in AISI 316L, with a large sight-glass in the centre to observe the product during the cycle. The door design, as well as the opening and closing mechanism, is configured to customer requirements, bearing in mind the final location of the unit, operating environment (isolators, RABS...) and loading and unloading features.
- TELSTAR freeze drying shelf inner channel design ensures high product homogeneity during freezing, primary and secondary drying stages.
- The SCADA LYOSTAR supervisory, control and data acquisition system designed by TELSTAR, allows the user to readily interpret the machine's operation and to obtain the information required for decision making and batch reporting, all in compliance with FDA 21 CFR part 11 registration and electronic signature guidelines.
- The equipment installations are designed according to the end user's requirements. Therefore, the unit can be supplied with mechanical or liquid nitrogen refrigeration, the vacuum system can be dry or oil-sealed with or without redundancy and a single or double venting filter can be installed with or without in-situ integrity test.
