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FTS LYOSTAR 3 - User Manual

FTS LYOSTAR 3
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LYOPHILIZER OPERATORS MANUAL
FTS
S
YSTEMS
L
YO
S
TAR
3
R
ESEARCH
&
D
EVELOPMENT
/
P
ILOT
-S
CALE
F
REEZE
D
RYER

Table of Contents

Questions and Answers

Summary

Original Instructions

Important Symbols

Freeze Dryer Safety Warnings

Warranty Information

Limited Warranty

Details the terms and conditions of the product warranty.

Introduction

Standard Features

Details the key features and capabilities of the LyoStar™™ 3 lyophilizer.

Equipment Options

Lists optional features and configurations available for the LyoStar™™ 3 lyophilizer.

Getting Started

Initial Inspection

Procedure for inspecting the lyophilizer for shipping damage upon receipt.

Setup Procedure

Step-by-step guide for installing and setting up the LyoStar™™ 3 lyophilizer.

Vacuum Pump Oil

Instructions for checking and maintaining vacuum pump oil levels and condition.

Oil Mist Eliminator

Ensuring the proper attachment of the oil mist eliminator.

Workstation Power Configuration

Verify workstation voltage selector switch configuration before connecting to power.

Connecting Control System Cables

Connecting data communication cables between the lyophilizer and workstation.

The Freeze-Drying System

Components and Subsystems

Overview of the main components and subsystems of the LyoStar™™ 3 lyophilizer.

Product Drying Chamber

Details the standard and ControLyo™™ chambers and their respective doors.

Product Shelves

Describes product shelves, shelf stack, latching, stoppering, and trays.

Shelf Heat-Transfer System

Explains the system for circulating heat transfer fluid through shelves.

TDLAS Spool Piece

Information on the vapor port for TDLAS apparatus installation.

Isolation Valve

Details the butterfly-type isolation valve and its function.

Condenser System

Describes the condenser chamber, cooling, door, and defrosting.

Refrigeration System

Explains the cascade refrigeration system and its utility requirements.

Aeration and Vacuum Level Control

Describes methods for controlling vacuum and aeration in the chambers.

Vacuum System

Details the vacuum pump, its function, and exhaust system.

Control System

Overview of the LyoS™ Control System and PLC.

Operating your Lyophilizer

Leak Rate and Function Testing

Procedure for performing automatic leak rate and function tests for the lyophilizer.

Preparation and Pretreatment

Ensures the product chamber, shelves, and condenser are clean and dry before operation.

Product Temperature-Monitoring Probes

Details probes, placement in bulk samples, vials, and unusual containers.

Thermocouple Connection

Ensures correct copper-to-copper connection for accurate thermocouple readings.

Pre-Freezing

Product samples must be frozen before the drying process begins.

Stoppers

Describes the system for seating stoppers in vials at the end of a cycle.

Freeze Drying

Overview of the two-phase freeze-drying cycle: freezing and drying.

Freezing; Thermal Treatment

Covers freezing methods and the use of ControLyo™™ technology.

Drying Steps 1-16

Details the primary drying phase where moisture sublimes.

Drying Step 17

Additional step for removing residual bound water from the product.

Completing the Cycle

Procedure for shutting down systems and unloading product.

Defrost

Instructions for defrosting the condenser after each cycle.

Liquid Nitrogen Trap

Operation

Step-by-step instructions for operating the auto-fill liquid nitrogen trap.

Cleaning

Procedure for cleaning the liquid nitrogen trap, including defrosting if needed.

Sample Extractor Assemblies

Standard Sample Extractor Assembly (Acrylic)

Details the components of the standard acrylic sample extractor assembly.

Sample Extractor Installation

Instructions for removing the standard door and installing the sample extractor.

Standard Sample Extractor Operation

Step-by-step guide for operating the standard acrylic sample extractor.

ASME-Coded Stainless Steel Sample Extractor Assembly

Describes the components of the ASME-coded stainless steel sample extractor.

ASME-Coded Sample Extractor Operation

Step-by-step guide for operating the ASME-coded stainless steel sample extractor.

Shelf Spacing

Adjusting shelf spacing using latching kits for larger vials.

Stoppering

Main Components

Details the main components of the LyoStar™™ 3 stoppering system.

Stoppering Procedure

Step-by-step instructions for operating the hydraulic stoppering mechanism.

Inert Gas Backfill

Process for backfilling the chamber with inert gas prior to stoppering.

Shelf-Latching

Shelf-Latching Kit Installation

Procedure for installing shelf-latching kits to adjust shelf spacing.

Praxairs ControLyo Nucleation On-Demand Technology

ControLyo Process Overview

Explains the pressurization, depressurization, and purging steps of the ControLyo™™ process.

Importance of Controlled Nucleation

Discusses the benefits of controlled nucleation on lyophilization outcomes.

Key Steps for ControLyo

Outlines the essential steps for utilizing the ControLyo™™ technology.

Mechanism

Discusses hypotheses regarding the mechanism by which ControLyo™™ induces nucleation.

Guidelines and Performance Expectations

Provides guidelines and expected performance for ControLyo™™ technology.

General Maintenance

Vacuum System Maintenance

Covers vacuum pump oil checks, changes, and oil mist eliminator.

Scheduling Vacuum Pump Oil Changes

Guidelines for determining the frequency of vacuum pump oil changes.

Gas Ballast Valve Maintenance

Explains the function and maintenance of the gas ballast valve.

Door Gasket Inspection

Instructions for inspecting and maintaining chamber and condenser door gaskets.

Air-Cooled Condenser Maintenance

Procedures for cleaning and maintaining the air-cooled condenser and compressor.

Water-Cooled Condenser Maintenance

Information on maintaining water-cooled condensers and water supply.

Condenser Chamber Cleaning

Guidelines for cleaning the condenser chamber, especially after processing corrosive materials.

Chemical Resistance Chart for Acrylic

Table showing acrylic resistance to various chemicals.

Recommended Monthly Maintenance Schedule

Tasks to be performed monthly for routine lyophilizer maintenance.

Recommended Quarterly Maintenance Schedule

Tasks to be performed quarterly for routine lyophilizer maintenance.

Recommended Annual Maintenance Schedule

Tasks to be performed annually for lyophilizer maintenance.

Recommended Five-Year Maintenance Schedule

Tasks to be performed every five years for comprehensive lyophilizer maintenance.

Appendix A: Sample Recipe

Sample Recipe: Freezing; Thermal Treatment

Sample recipe parameters for the freezing and thermal treatment phases.

Sample Recipe: Drying Phase

Sample recipe parameters for the drying phase of lyophilization.

Sample Recipe: Product Storage

Sample recipe parameters for product storage and backfill/stoppering.

Appendix B: Troubleshooting

Troubleshooting Chart

A guide to diagnosing and resolving common freeze-dryer issues.

Vacuum System Troubleshooting

Steps for diagnosing and resolving vacuum system related problems.

Chamber Vacuum Leak Check

Procedure for checking product and condenser chambers for vacuum leaks.

Appendix C: Stainless Steel Cleaners

Cleaning Heat Tint and Discoloration

Methods for cleaning heat tint and heavy discoloration on stainless steel.

Cleaning Stubborn Deposits and Stains

Recommended cleaners for tenacious deposits and atmospheric stains.

Cleaning Hard Water Spots and Scale

Procedure for removing hard water spots and scale from stainless steel.

FTS LYOSTAR 3 Specifications

General IconGeneral
BrandFTS
ModelLYOSTAR 3
CategoryDryer
LanguageEnglish

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