21 CFR Part 11 Compliant

Upgrade your freeze dryer’s control system and improve product quality!

The Lyolab984 micro-controller was designed to control and monitor the main lyophilization parameters on a variety of machines. The Lyolab984 combines the functions of separate temperature and pressure controllers together with the cycle sequencer to integrate the automation of the lyophilization cycle on a Windows 2000 ® PC. The Lyolab984 comes with a moderate price tag and targets the retrofit market.

We believe that a control system must facilitate the inter-relationship between the freeze dryer, the product, the recipe and the operator. Therefore, a control design must be evaluated in its ability to:

  • minimize operator error
  • clearly define recipe parameters
  • provide a synoptic of the machine for maintenance
  • automate intervention (AI) to alert possible malfunctions and product related behavior deviations
  • facilitate cycle modifications before and during a cycle
  • document a cycle in both data log and graph modes
  • support cGMP operation
  • be user-friendly

The LyoLab984 Micro-controller was designed with these functional characteristics in mind.

Ask for a LyoLab984 demonstration.

One of the most important functions of a fully integrated control system is to simplify recipe definition. With our unique EZ-n-Tree screens, recipe definition is a breeze. Creating a cycle profile for lyophilization is simplified by a series of prompting messages, help screens and warnings. Once a recipe is outlined, the temperature profile can be plotted, providing a visual representation of the recipe prior to running a cycle.

Since readable and accessible data is important in cycle development, the cycle batch log can be printed in a variety of formats, including graphical and numerical modes. Cycle data can also be imported into most spreadsheets, databases, and can even be appended to a document with a word processor. Our software is among the most flexible on the market.

Lyolab 984 features include:

  • Automated lyophilization cycle
  • Automated performance cycle
  • Manual synoptic mode
  • Alarms and safeties annunciation
  • Offline analysis of logs and graphs
  • Password access security
  • Multiple data presentation (event log, graphic)
  • Graphic recipe utility
  • PLC-OMI Smart Link monitoring
  • Recipe conversion utility
  • Printing of logs/graphs in full color
  • Simulation mode for training
  • Easy to learn interface

At Lyotech we understand that a control system is only as good as its supporting documentation. In the cGMP environment of most pharmaceutical manufacturing, documentation is critical for effective qualification of the control system. The LyoLab984 Micro-controller, which includes the PLC logic and OMI software, was designed for such a cGMP environment. The PLC ladder logic and the OMI code are fully documented including an operator interface manual, an interface technical supplement, and electrical schematics. In addition, a Control Qualification (CQ) package is offered, providing static I/O testing, safety interlock checks, sequencing checks and software test scripts (black box testing), for complete GMP readiness.