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SP Scientific LYOSTAR II - User Manual

SP Scientific LYOSTAR II
72 pages
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LYOPHILIZER OPERATORS MANUAL
FTS
S
YSTEMS
L
YO
S
TAR
II
S
TANDARD

Table of Contents

Questions and Answers

Summary

Important Symbols

Freeze Dryer Safety Warnings

Warranty Information

Introduction

Overview

Introduction to the LyoStar II freeze dryer and its components.

Getting Started

Initial Inspection

Procedures for inspecting the lyophilizer upon receipt for any shipping damage.

System Checklist

Pre-operation checks to ensure the lyophilizer is ready for use.

Placement and Initial Set-Up

Guidance on positioning and initial setup of the lyophilizer.

Ambient Temperature

Recommended ambient temperature and humidity for optimal performance.

Heat Transfer Fluid-Initial Set-up

Instructions for checking and setting the heat transfer fluid level.

Electrical Requirements

Details on the power supply and electrical connections needed for the unit.

Inert Gas;Air

Requirements for compressed air and inert gas sources for operation.

Cooling Water Requirements (Water Cooled Units Only)

Specifications for cooling water for water-cooled models.

Vacuum Pump Installation

Procedures for installing and preparing the vacuum pump.

Door Closure

Information regarding the proper sealing and maintenance of the chamber door gasket.

Internal Stoppering Operation

How to use the internal stoppering mechanism for vials and bottles.

Operating Your Lyophilizer

Leak Rate and Function Testing

Procedures for performing leak rate and system tests for performance verification.

Leak Rate Testing

Detailed steps for conducting a leak rate test to check vacuum integrity.

System Testing

Steps to perform a system test to measure refrigeration performance.

Thermocouple Placement

Guidelines for correct placement of thermocouples for accurate lyophilization runs.

Manual Mode of Operation

How to operate the freeze dryer using manual control of individual features.

Automatic Run

Steps for setting up and running an automatic freeze-drying process using recipes.

Programming Tips

Advice for creating and optimizing freeze-drying recipes.

To Create a New Recipe:

Instructions for creating a new custom freeze-drying recipe.

To Change the Recipe While the System Is Executing the Program:

How to modify recipe parameters during an active freeze-drying run.

Data Management

Alphanumeric Data

Information on collecting and interpreting alphanumeric data from runs.

LyoStar LyoManager Software Phase and Step Guide

Explanation of phases and steps in the software for tracking run progress.

Export to Spreadsheet

How to export collected data into a spreadsheet format for analysis.

Graphical Display

Viewing graphical representations of run data over different time intervals.

Defrost

Procedure for defrosting the condenser after a run.

Optional Liquid Nitrogen Trap-Auto Filling

Overview

Introduction to the auto-filling liquid nitrogen trap for pump protection.

Utility Requirements

Power and liquid nitrogen requirements for the trap system.

Operation

Steps for operating the auto-filling liquid nitrogen trap.

Cleaning

Procedures for cleaning the liquid nitrogen trap components.

Side Wrapper Removal

Instructions for removing the side wrapper for access or maintenance.

Optional Sample Extractor Assembly

Description

Overview of the Sample Extractor Assembly (SEA) and its purpose.

SEA Installation Instructions

Steps for installing the Sample Extractor Assembly onto the lyophilizer door.

Standard Door Removal

How to remove the standard door to prepare for SEA installation.

SEA Installation

Detailed steps for mounting the SEA onto the lyophilizer.

Operation

How to use the Sample Extractor Assembly for removing samples.

Shelf Area

Information on the shelf configuration and accessible area.

Electrical Requirements

Electrical specifications for the Sample Extractor Assembly.

Optional Isolation Valve

Isolation Valve

General information about isolation valves, pneumatic or electrical.

Electrical Isolation Valves

How electrical isolation valves operate automatically during cycles.

Pneumatic Isolation Valves

Requirements and operation of pneumatic isolation valves.

Use with Liquid Nitrogen Trap

Using the isolation valve in conjunction with the liquid nitrogen trap.

Optional Shelf-Latching Kit

Installation

Step-by-step guide for installing the shelf-latching kit.

Optional Cleanroom Configuration

Overview

Notes on deviations from standard configuration for cleanroom use.

Placement and Initial Set-Up

Specific placement and setup instructions for cleanroom configurations.

General Maintenance

Synoptic Screen

Using the Synoptic screen to monitor system status and component states.

Maintenance Screen

Accessing and using the Maintenance screen for component control and diagnostics.

Tune

Fine-tuning the control system parameters with SP Scientific guidance.

Calibration of Product Thermocouples

Procedure for calibrating product thermocouples for accurate readings.

System Maintenance

Routine maintenance schedule and tasks for optimal performance and longevity.

Appendix A: Troubleshooting

General Troubleshooting

Common issues and solutions for system response and startup problems.

Vacuum System Troubleshooting

Steps to diagnose and resolve vacuum leaks in the system.

SP Scientific LYOSTAR II Specifications

General IconGeneral
Number of Shelves6
Shelf Temperature Uniformity±1 °C
Condenser Temperature-85 °C
Data LoggingYes
TypeLyophilizer

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