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PBI SAS SUPER IAQ User Manual

PBI SAS SUPER IAQ
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ENGLISH
“SAS SUPER IAQ” - Code n. 90578
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Carefully read this Manual before operating your instrument.
This document is the property of International PBI Spa Milan
It may not be duplicated or distributed without the owner’s authorisation
Patent Pending
Manufactured by International PBI Spa Milan, Italy
REFERENCES
FDA – 1987 Guideline on Sterile Drug Products produced by Aseptic Process
ACGIH – Guideline for the Assessment of Bioaerosol in the Indoor Environment
ASTM – Draft Protocol – Committee D22.05.06
USP 23-NF 18 8
th
Supplement 1116 (May 1998) – Microbiological Evaluation of Clean Rooms
and other Controlled Environments
EU Guide for GMP – Manufacture of Sterile Medicinal Products Control of Medicines and
Inspection
CEN/TC 243 Norms for Clean Room Technology
International PBI S.p.A.
Via Novara, 89 – 20153 Milano – Italy – Tel + 39 02 48779-1– Fax + 39 02 40090010
E-mail:
info@internationalpbi.it www.internationalpbi.it

Questions and Answers:

PBI SAS SUPER IAQ Specifications

General IconGeneral
BrandPBI
ModelSAS SUPER IAQ
CategoryMeasuring Instruments
LanguageEnglish

Summary

Section One: Getting Started

Brief Operating Instructions

Concise guide for initial operation of the SAS Super IAQ instrument.

Visual Display Presentation

Details the information shown on the instrument's display upon startup.

Section Two: Operating Instructions

Principle of Surface Air System

Explains the fundamental operating principle of the SAS air sampler.

The Basic Idea

Outlines the core concepts and advantages of the SAS system.

Installation and Practical Use

Covers the installation and practical handling of contact plates for air sampling.

List of Menu and Utility Sub-Menu

Details the available menus and their sub-menus for instrument configuration.

Preliminary Inspection

Procedures for inspecting the instrument for transit damage and initial setup.

Contact Plate Holders and Maxi Plates

Information on adjusting plate holders and using larger Maxi-Contact Plates.

Tripod Installation (Optional)

Optional procedure for attaching the sampler to a tripod.

Operations

Starting Air Sampling

Instructions for initiating air sampling cycles.

User Mode Programming

How to select and use pre-programmed sampling volumes.

Program Mode for Volume Modification

Procedure to modify existing or program new sampling volumes.

Utility Mode Program Functions

Accessing and using utility functions like setting time and language.

Delay Mode Operation

Setting a delay before the start of an air sampling cycle.

Low Battery Message and Remote Switch Use

Handling low battery warnings and using the infrared remote switch.

Maintenance and Handling

Contact Plate Handling

Steps for proper handling, disinfection, and use of contact plates.

Sanitation of Air Sampler

Methods for cleaning and disinfecting the air sampler and its parts.

Contact Plates Preparation

Guidelines for preparing contact plates with agar for sampling.

Specifications

Principle and Air Flow Rate

Details the operating principle and nominal air flow rate of the SAS Super IAQ.

Battery Pack and Autonomy

Information on the battery specifications and operational autonomy.

Construction and Sampling Efficiency

Describes the materials used and the air sampling efficiency of the unit.

Parts and Controls

Contact Plate Chamber and Upper Panel

Identifies components of the contact plate chamber and the upper panel.

Front Control Panel Overview

Explains the functions of the buttons and display on the front control panel.

Bottom Panel Identification

Details the components located on the bottom panel of the instrument.

Display Messages

Common Display Messages

Lists and explains the various messages that can appear on the instrument's display.

Operational Data

Sampling Time Requirements

Table showing the time required for different air sample volumes.

Battery Charger Operations

Instructions for charging the instrument's battery pack correctly.

Maintenance

Cleaning Procedures

Recommended methods for cleaning the air sampler to maintain its condition.

Validation and Calibration

Guidance on validating and calibrating the air flow rate of the instrument.

Performance Routine Monitoring

Methods for regularly checking the instrument's working condition and performance.

Troubleshooting and Battery

Troubleshooting Common Problems

Solutions for common issues encountered with the air sampler.

Battery Replacement Procedure

Step-by-step guide for replacing the instrument's battery.

Accessories and Consumables

Accessory and Spare Part List

Catalog of available accessories and spare parts for the SAS Super IAQ.

Agar Contact Plates

List of ready-to-use media-filled sterile contact plates for sampling.

Brief Instructions

Starting Air Sampling (Previous Sample)

Quick guide to start sampling with the same volume as the last cycle.

Starting Air Sampling (User Mode)

Instructions for initiating sampling using pre-memorised user modes.

ISO EN 17025 Documentation

Instrument Identification Sheet

Template for identifying the instrument according to ISO EN 17025 standards.

Authorization and Return

Return Authorization Form

Form for requesting return authorization for the instrument for service.

Decontamination Form

Instrument Decontamination Procedure

Form and instructions for decontaminating the instrument before service.

Warranty and Customer Attention

Warranty Conditions

Terms and conditions of the product warranty provided by International PBI.

Attention to New Customers

Information and request for new customers regarding guarantee registration.

Declaration of Conformity

Product Compliance Statement

Statement confirming the product's compliance with relevant directives and standards.

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