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Germfree LFGI-3USP User Manual

Germfree LFGI-3USP
85 pages
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Laminar Flow LFGI (CAI or CACI) User Manual
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Germfree LFGI-3USP Specifications

General IconGeneral
CategoryIndustrial Equipment
ModelLFGI-3USP
AirflowVertical Laminar Flow
MaterialStainless steel
Glove Ports3
HEPA FilterYes
HEPA Filter Efficiency99.99% at 0.3 microns
PrefilterYes
LightingLED
StandardUSP 797
DimensionsVaries
ApplicationPharmaceutical compounding
Work Zone Dimensions (W x D x H)36 x 24 x 24 in
Airflow Velocity90 fpm
Electrical60Hz
TypeLaminar Flow Glovebox Isolator

Summary

Preface

Safety, Operation and Additional Professional Training

Details essential training topics for safe and effective operation of the LFGI, covering technique and regulatory compliance.

Introduction

Product Protection

Explains how the LFGI safeguards the product through HEPA filtration and unidirectional airflow.

Personnel Protection

Describes how the LFGI creates a barrier to protect operators from hazardous materials.

Particulates and Gases/ Vapors

Covers protection against particulates, dust, powders, aerosols, and limited protection for gas/fumes.

Theory

HEPA Filtration

Explains HEPA filter mechanisms, efficiency, and particulate removal capabilities.

Unidirectional (Laminar) Air Flow

Details the vertical laminar flow for product protection and contamination reduction.

Pressurization

Explains positive (Isolator) and negative (Glovebox) pressure configurations.

Containment

Describes how filters and construction maintain containment of the work area.

Unpacking Instructions

Installation

Electrical Requirements

Certification

Outlines the necessity of post-installation certification for filters, airflow, and pressure.

Parts Identifier

Front of LFGI

Identifies external components of the LFGI unit.

Inside the Work Area

Identifies internal components within the LFGI work area.

Inside the Work Area #2

Further identification of internal components and their locations.

Sharps and Waste

Details the components for sharps and waste disposal within the LFGI.

Back of the Control Panel

Identifies components located on the rear of the control panel.

Control Panel

Identifies components and indicators on the main control panel.

Cleaning

Outside the LFGI

Instructions for cleaning the exterior surfaces of the LFGI.

Inside the LFGI

Procedures for cleaning the interior of the LFGI work area.

Operation

Airlock Operation

Explains the function and use of the airlock for material transfer.

Usage

Lists important 'Do Not' and 'Do' guidelines for safe and effective operation.

Practice Proper Aseptic Technique

Emphasizes the importance of aseptic technique, not replaceable by equipment.

Appendices

Warranty Information (2 year standard)

Details the terms, coverage, and limitations of the manufacturer's warranty.

Maintenance

Covers recommended maintenance schedules for gloves, prefilters, and HEPA filters.

Light Bulb Replacement

Step-by-step instructions for replacing the internal lighting.

Ducting

Discusses LFGI venting options and external ducting configurations.

Electronic Adjusting Stand

Explains the operation and features of the height adjustment mechanism.

Automated Compounders

Information on integrating automated compounding equipment with the LFGI.

Assembly Instruction Roxtec Gland M63

Detailed steps for assembling the Roxtec Gland M63 sealing system.

Gloves

Recommendations for suitable glove types and materials for use with the LFGI.

Alarm

Describes the low pressure alarm and troubleshooting for alarm conditions.

Glove and Sleeve Maintenance

Covers procedures for changing gloves, sleeves, and performing inspections.

Cleaning Procedures

Details rigorous and light cleaning procedures for the LFGI.

Cleaning Agents

Lists recommended cleaning agents, their uses, examples, and brand names.

Cleaning Terms

Definitions of common cleaning and sanitization terminology.

LFGI- USP Specification Sheets

SECTION I. PERFORMANCE DATA

Outlines the performance capabilities and standards met by the LFGI USP series.

SECTION II. EQUIPMENT SPECIFICATIONS

Details the physical construction, dimensions, and features of the LFGI.

Construction

Specifics on materials, dimensions, and design features of the LFGI.

Antechamber

Describes the sealed two-door airlock and its environmental separation function.

Waste Removal

Details the trash and sharps tubes and associated collection systems.

Safety

Covers safety features like lock-out handles, pressure alarms, and glove changes.

Ergonomics

Features designed for operator comfort and efficiency, like height adjustment.

Configuration Options

Discusses adjustable aspects like pressure, airlock orientation, and exhaust.

Filtration

Details the HEPA filter types, coverage, and prefilter usage.

Electrical

Specifications for power requirements, motor systems, and lighting.

Exhaust

Describes exhaust options, connection types, and airflow specifications.

Weight

Provides net and shipping weight specifications for the unit.

SECTION III. OPTIONAL EQUIPMENT AND ACCESSORIES-

Lists optional accessories available for purchase with the LFGI.

SECTION IV. UNIT DIAGRAM

Presents a visual diagram with key dimensions of the LFGI unit.

UNIT SPECIFICATIONS SHEET LFGI-4USP LAMINAR FLOW GLOVEBOX / ISOLATOR

SECTION I. PERFORMANCE DATA

Outlines the performance capabilities and standards met by the LFGI-4USP.

SECTION II. EQUIPMENT SPECIFICATIONS

Details the physical construction, dimensions, and features of the LFGI-4USP.

Construction

Specifics on materials, dimensions, and design features of the LFGI-4USP.

Antechamber

Describes the sealed two-door airlock and its environmental separation function.

Waste Removal

Details the trash and sharps tubes and associated collection systems.

Safety

Covers safety features like lock-out handles, pressure alarms, and glove changes.

Ergonomics

Features designed for operator comfort and efficiency, like height adjustment.

Configuration Options

Discusses adjustable aspects like pressure, airlock orientation, and exhaust.

Filtration

Details the HEPA filter types, coverage, and prefilter usage.

Electrical

Specifications for power requirements, motor systems, and lighting.

Exhaust

Describes exhaust options, connection types, and airflow specifications.

Weight

Provides net and shipping weight specifications for the unit.

SECTION III. OPTIONAL EQUIPMENT AND ACCESSORIES-

Lists optional accessories available for purchase with the LFGI-4USP.

SECTION IV. UNIT DIAGRAM

Presents a visual diagram with key dimensions of the LFGI-4USP unit.

UNIT SPECIFICATIONS SHEET LFGI-6USP LAMINAR FLOW GLOVEBOX / ISOLATOR

SECTION I. PERFORMANCE DATA

Outlines the performance capabilities and standards met by the LFGI-6USP.

SECTION II. EQUIPMENT SPECIFICATIONS

Details the physical construction, dimensions, and features of the LFGI-6USP.

Construction

Specifics on materials, dimensions, and design features of the LFGI-6USP.

Antechamber

Describes the sealed two-door airlock and its environmental separation function.

Waste Removal

Details the trash and sharps tubes and associated collection systems.

Safety

Covers safety features like lock-out handles, pressure alarms, and glove changes.

Ergonomics

Features designed for operator comfort and efficiency, like height adjustment.

Configuration Options

Discusses adjustable aspects like pressure, airlock orientation, and exhaust.

Filtration

Details the HEPA filter types, coverage, and prefilter usage.

Electrical

Specifications for power requirements, motor systems, and lighting.

Exhaust

Describes exhaust options, connection types, and airflow specifications.

Weight

Provides net and shipping weight specifications for the unit.

SECTION III. OPTIONAL EQUIPMENT AND ACCESSORIES-

Lists optional accessories available for purchase with the LFGI-6USP.

SECTION IV. UNIT DIAGRAM

Presents a visual diagram with key dimensions of the LFGI-6USP unit.

Certification of GERMFREE Laminar Flow Glovebox / Isolator

Models

Lists the available LFGI USP models.

Product Overview

Introduces the LFGI USP series and its features for sterile preparations.

Basic Operation

Airflow Set Up

Guides on adjusting airflow and pressure for optimal unit performance.

Isolator Pressure

Explains positive/negative pressure settings and ISO Class 5 air quality.

Supply Velocity

Details the average supply velocity range and measurement points.

Particle Counts

Procedures for verifying ISO Class 5 conditions via particle sampling.

Filter Integrity

Describes methods for testing the integrity of main and airlock HEPA filters.

Back of the Control Panel

Identifies components located on the rear of the control panel.

Replacement Filter Sizes & Part Numbers

Lists part numbers and sizes for various LFGI filters.

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