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Germfree LFGI-4USP User Manual

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Germfree LFGI-4USP Specifications

General IconGeneral
BrandGermfree
ModelLFGI-4USP
CategoryIndustrial Equipment
LanguageEnglish

Summary

Preface

Safety, Operation and Professional Training

Key topics for safe and effective LFGI use, requiring professional understanding and practice.

LFGI and USP <797> Guidelines

Guidelines for LFGI use in pharmacy, aligning with USP standards and manufacturer recommendations.

Introduction to LFGI

Product Protection Features

How the LFGI provides a sterile environment for product safety via HEPA filtration and unidirectional airflow.

Personnel Protection Features

How the LFGI creates a barrier against hazardous materials for operator safety through HEPA exhaust.

Particulates, Gases, and Vapors

Protection against particulates, dust, aerosols, and limited protection from gases/fumes via HEPA filtration.

Theory of Operation

HEPA Filtration Principles

Explains HEPA filter mechanisms (impingement, interception, diffusion) and efficiency in particle removal.

Airflow Dynamics and Pressurization

Details unidirectional airflow, positive/negative pressure configurations (Isolator/Glovebox).

Containment Mechanisms

How the LFGI maintains containment via filters, construction, sealed components, and airlock.

Setup and Installation

Unpacking Instructions

Guide for safely unpacking the LFGI unit, including inspection for damage upon receipt.

Installation Procedures

Guidance on positioning the LFGI, fitting through doorways, and initial setup steps before operation.

Electrical Requirements

Specifies power needs, plug types, grounding, and circuit requirements for LFGI operation.

Certification Process

Outlines the necessity of post-installation certification for verifying LFGI performance and safety.

LFGI Components and Identification

External Parts Overview

Identifies external components like airlock, control panel, viewing panel, and gloveports.

Internal Work Area Components

Labels internal components within the work area, such as HEPA filters, trays, and return grilles.

Waste and Sharps Disposal System

Details the sharps and waste tubes, collector shelf, and optional containers for safe disposal.

Control Panel Identification

Explains the function of gauges, switches, and indicators on the LFGI's main control panel.

Cleaning and Maintenance

Exterior and Interior Cleaning

Procedures for cleaning LFGI exterior, interior, and airlock using approved agents and methods.

Light Cleaning Between Preparations

Procedure for light cleaning and sanitizing the LFGI work area between preparations using alcohol.

Recommended Cleaning Agents

Lists classes of cleaning agents, uses, examples, and brand names for LFGI cleaning and disinfection.

Maintenance Schedules and Lifespans

Guidance on typical lifespans and replacement schedules for glove sleeves, prefilters, and HEPA filters.

Operation and Safety Guidelines

Start-Up and Basic Operation

Detailed steps for initial LFGI startup, blower activation, purging, and basic operational procedures.

Airlock and Usage Procedures

Explains airlock operation for material transfer and lists essential usage guidelines ('Do' and 'Do Not').

Aseptic Technique and Safety

Emphasizes aseptic technique importance; equipment as a tool, not a substitute for proper practice.

Glove and Sleeve Management

Step-by-step procedures for changing gloves and sleeves, including modification for in-operation changes.

Alarm System and Troubleshooting

Details alarm causes (pressure drops), troubleshooting steps, and corrective actions for the LFGI.

System Specifications and Options

LFGI Model Specifications

Details construction, dimensions, performance data, and features for LFGI-3, -4, and -6USP models.

Unit Diagrams and Dimensions

Provides overall unit diagrams with key dimensions and labels for different LFGI models.

Optional Equipment and Accessories

Lists available optional accessories like chairs, cleaning tools, and ventilation kits for the LFGI.

Replacement Filter Information

Lists part numbers and sizes for various replacement filters (prefilters, HEPA) for LFGI models.

GERMFREE Certification and Overview

Certification Process Details

Explains the certification process, including integrity tests and velocity measurements for LFGI units.

Product Overview and Features

Introduces the LFGI USP Series, highlighting its features for sterile preparations and hazardous drugs.

Airflow, Pressure, and Particle Counts

Details airflow setup, isolator pressure settings, and particle count verification for ISO Class 5.

Filter Integrity Testing

Explains how to test HEPA filter integrity using a photometer and aerosol challenge procedures.

Sensocon Differential Pressure Controller

Introduction and Specifications

Overview of Sensocon controller capabilities, model configuration, and technical specifications.

Installation and Mounting

Instructions for installing and mounting the Sensocon controller, including panel cutouts and covers.

Electrical and Pressure Connections

Illustrates electrical wiring and pressure tubing connections for the Sensocon controller.

Display and Key Functions

Describes the Sensocon controller's display elements and the function of its navigation buttons.

Programming Menu Structure

Outlines the Sensocon controller's menu hierarchy: Main, Set-up, and Secure menus.

Control Modes and Settings

Explains operational modes like HiLo, Setpoint Deadband, and actuation parameters for the controller.

Alarms, Delays, and Advanced Settings

Details alarm types, delays, inhibit functions, and advanced settings like peak/valley values.

Output Scaling and Variable Management

Covers scaling 4-20mA output, moving variables, and using OptiLinkā„¢ for program management.

Sensocon Limited Warranty

Details the limited one-year warranty for Sensocon products, including terms and exclusions.

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