Modular GMP Freeze Dryer

A complete and reliable base unit

Each LyoZeta is configured as a compact unit in mono-bloc configuration that can be installed through the wall of the sterile room while offering easy maintenance access to all elements and optimizing the total space necessary.

The base unit has the following features:

• It covers freeze drying areas from 4 m2 to 50 m2.
• Rectangular chamber manufactured in AISI 316 L stainless steel.
• Horizontal cylindrical condenser manufactured in AISI 316L stainless steel, which can be located behind or at the lateral side of the chamber.
• Cartridge mushroom valve or butterfly valve to isolate the condenser and the chamber. See more about cartridge mushroom valve…
• The internals of the chamber-condenser group are polished and have a self-draining design to promote effective cleaning and sterilization.
• The door is constructed in AISI 316L, with a sight-glass in the centre to observe the product during the cycle.
• The equipment installations are designed according to the end user’s requirements.  The Mechanical refrigeration and vacuum system can be dry or oil-sealed, with or without redundancy.
• Telstar freeze drying inner channel design shelf ensures high product homogeneity during the freezing and primary and secondary drying stages.

• Loading and unloading systems to manage different formats of production. Solutions as manual, semiautomatic or completely automatic system. See more about loading and unloading systems… (INTEGRAL)
• OEM components from first brands widely available in the marketplace. Valves, filters, measuring instruments and other components are of a high quality and provide state of the art technology.
• The freeze dryer system offers the possibility to select modular redundancy. This means the customer is able choose the redundancy levels, considering redundancy on the main installation such as refrigeration or vacuum groups.

Control Systems. User-friendly solutions for maximum efficiency

The SCADA  supervisory, control and data acquisition system designed by Telstar, allows the user to readily interpret the machine’s operation and obtain information on the process required for decision making and batch reporting, all in compliance with FDA 21 CFR part 11 electronic record guidelines.

Designed thinking on GMP

Main components such as the chamber, freeze drying shelves, condenser, and process pipe work are constructed in stainless steel AISI 316L and are mechanically polished to Ra ≤ 0.51 μm as standard. Sanitary fittings are sealed with pharmaceutical grade gaskets and piping joints are orbital or TIG welded.

Technical guidance and fluent communication

The project is handled by a project manager that coordinates the communication between the customer and the rest of the project team, who are experts in mechanical, control, validation and manufacturing.

Wide field of applications

For either bulk format or liquid in vials, ampoules or syringes, the LyoZeta units are designed for freeze drying high value products, such as:

• Vaccines
• Cytostatics
• Antibiotics
• Biologicals
• Hormones
• Active ingredients
• Reactives

Accessories & Options

When engineering modular systems, the standard model range Telstar offer will provide the most appropiate solutions to meet the most common requirements and challenges in the industry. A comprehensive number of options have to be adapted to match the particular needs of the customer.

• Vial stoppering systems
• AISI 316 stainless steel bellows for stoppering ram isolation
• Constant height loading system
• Automatic door latching and locking system
• Sub-door for loading and unloading
• CIP cleaning system
• SIP sterilization system
• Vacuum group with dry pumps
• Redundant critical components
• Product trays
• Qualification service
• Freeze drying development support laboratory
• Preventive maintenance programs
• Calibration series
• Training services
• Upgrade & Refurbishment
• Solvents and high potent products