SCIEX PA 800 Plus Guida all'installazione

PA 800 Plus Pharmaceutical Analysis

System

System Overview Guide

RUO-IDV-05-5521-A

January 2018

This document is provided to customers who have purchased SCIEX equipment to use in the

operation of such SCIEX equipment. This document is copyright protected and any reproduction

of this document or any part of this document is strictly prohibited, except as SCIEX may

authorize in writing.

Software that may be described in this document is furnished under a license agreement. It is

against the law to copy, modify, or distribute the software on any medium, except as specifically

allowed in the license agreement. Furthermore, the license agreement may prohibit the software

from being disassembled, reverse engineered, or decompiled for any purpose. Warranties are as

stated therein.

Portions of this document may make reference to other manufacturers and/or their products,

which may contain parts whose names are registered as trademarks and/or function as

trademarks of their respective owners. Any such use is intended only to designate those

manufacturers' products as supplied by SCIEX for incorporation into its equipment and does not

imply any right and/or license to use or permit others to use such manufacturers' and/or their

product names as trademarks.

SCIEX warranties are limited to those express warranties provided at the time of sale or license

of its products and are SCIEX’s sole and exclusive representations, warranties, and obligations.

SCIEX makes no other warranty of any kind whatsoever, expressed or implied, including without

limitation, warranties of merchantability or fitness for a particular purpose, whether arising from a

statute or otherwise in law or from a course of dealing or usage of trade, all of which are

expressly disclaimed, and assumes no responsibility or contingent liability, including indirect or

consequential damages, for any use by the purchaser or for any adverse circumstances arising

therefrom.

For research use only. Not for use in diagnostic procedures.

AB Sciex is doing business as SCIEX.

The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective

owners.

AB SCIEX™ is being used under license.

PA 800 Plus Pharmaceutical Analysis System System Overview Guide

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AB Sciex LLC

500 Old Connecticut Path

Framingham, Massuchesetts 01701

USA

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Contents

CHAPTER 1: Safety, Notices and Labels, 7

Overview, 7

General Safety Information, 7

Alerts for Warning, Caution, Important, and Note, 8

Instrument Safety Precautions, 8

Moving Parts or Sharp Objects, 8

Chemical Precautions, 9

Safety Symbols and Labels, 9

High Voltage Electric Shock Risk Symbol, 9

Sharp Object Label, 9

General Biohazard Symbol, 10

Caution, Biohazard Label, 10

Class 1 Laser Caution Label, 10

RoHS Notices, 10

China RoHS Caution Label, 10

China RoHS Environmental Label, 11

Other Instrument Labels, 11

Recycling Label (WEEE), 11

Disposal of Devices Containing Mercury Components, 12

CHAPTER 2: System Overview, 13

Instrument, 13

Sample Handling System, 15

Capillary Cartridge, 17

Fluid Delivery, Power Supply, and Interlocks, 18

Syringe Pump, 18

High Voltage Power Supply, 18

LED Indicators, 18

Cartridge and Sample Cover Interlocks, 18

UV Detector Optics, 19

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Contents

The Photodiode Array (PDA) Detector, 20

The Laser Induced Fluorescence (LIF) Detector, 21

Laser Module, 22

488 nm Laser Module, 22

Supported Applications, 23

IgG Purity/Heterogeneity Assay, 23

SDS Molecular Weight Analysis, 23

Capillary Isoelectric Focusing (cIEF) Analysis, 23

Carbohydrate Analysis, 23

CHAPTER 3: System Procedures and Training Guide, 25

Controller and Instrument Start Up, 25

Controller/Network Logon, 25

License Key, 25

PA 800 Plus Software, 26

Enterprise Window, 26

Instrument Start Up, 27

System Administration, 27

Configuration, 29

Online versus Offline, 30

How to Load the Cartridge and Samples, 30

How to Run a Method, 33

Analysis, 36

Area Calculation, 40

Annotations, 41

Peak Identity, 42

Run Multiple Methods with a Sequence, 42

Viewing Reports, 47

Standard Reports, 47

Method Custom Reports, 47

Sequence Custom Report, 47

Advanced Reports, 47

Suitability Reports, 49

Viewing and Printing Reports, 49

Maintenance, 49

APPENDIX A: Specifications, 51

PA 800 System, 51

Computer Requirements, 52

UV Detector, 52

PDA Detector, 53

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Contents

LIF Detector, 53

Sample Cooling, 54

Revision History, 55

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Contents

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CHAPTER 1

Safety, Notices and Labels

Overview

A description of the symbols and labels that are used on the SCIEX PA 800 Plus Pharmaceutical Analysis System,

or that are shown in this guide, can be found in this section.

Do not attempt to perform any procedure before carefully reading all instructions. If in doubt as to how to

proceed in any situation, contact your SCIEX Representative.

General Safety Information

To prevent personal injury or system damage, read, understand, and obey all of the safety precautions and

warnings in this document and product label information. These labels are shown with internationally

recognized symbols. Failure to heed these warnings could result in serious injury. This safety information is

intended to supplement federal, state, provincial, and local environmental health and safety (EHS) regulations.

The information provided covers system related safety information applicable to the operation of the system. It

does not cover every safety procedure that should be practiced. Ultimately, the user and the organization are

responsible for compliance with federal, state, provincial, and local EHS regulations and for maintaining a safe

laboratory environment.

Refer to the appropriate laboratory reference material and standard operating procedures.

WARNING

If the equipment is used in a manner not specified by SCIEX the protection provided by the

instrument may be impaired.

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Safety, Notices and Labels

Alerts for Warning, Caution, Important, and Note

All warnings and cautions in this document include an exclamation point, framed within a triangle.

The exclamation point symbol is an international symbol which serves as a reminder that all safety instructions

should be read and understood before installation, use, maintenance, and servicing are attempted.

WARNING

WARNING indicates a potentially hazardous situation which, if not avoided, could result in

death or serious injury. It may also be used to indicate the possibility of erroneous data that

could result in an incorrect determination. May be used to indicate the possibility of severe

instrument damage.

CAUTION

CAUTION indicates a potentially hazardous situation, which, if not avoided, may result in minor

or moderate injury. It may also be used to alert against unsafe practices. May be used to

indicate the possibility of erroneous data that could result in an incorrect determination.

IMPORTANT Used for comments that add value to the step or procedure being performed. Following the advice in

the IMPORTANT adds benefit to the performance of a piece of equipment or to a process.

NOTE Used to call attention to notable information that should be followed during installation, use, or servicing of

this equipment.

Instrument Safety Precautions

Moving Parts or Sharp Objects

WARNING

Risk of personal injury. To avoid injury due to moving parts, observe the following:

• Never attempt to exchange labware, reagents, or tools while the instrument is operating.

• Never attempt to physically restrict any of the moving components of the instrument.

• Keep the instrument work area clear to prevent obstruction of the movement.

Moving parts are limited to the sample handling system. Plate movement is safety interlocked through the

sample access cover. To avoid injury due to moving parts, observe the following:

• Keep loose clothing and hair away from the plate area.

• Never attempt to physically restrict movement of the plate assembly.

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Safety, Notices and Labels

Chemical Precautions

• A description of the symbols and labels that are used on the SCIEX PA 800 Plus Pharmaceutical Analysis, or

that are shown in this guide, can be found in this section.

• Work in a well-ventilated area.

• Always wear assigned personal protective equipment, including powder-free neoprene or nitrile gloves,

safety glasses, and a laboratory coat.

• Follow required electrical safe work practices.

• Avoid ignition sources when working with flammable materials, such as isopropanol, methanol, and other

flammable solvents.

• Take care in the use and disposal of any chemicals. Potential risk of personal injury if proper procedures for

handling and disposing of chemicals are not followed.

• Avoid skin contact with chemicals during cleaning and wash hands after use.

• Comply with all of the local regulations for the storage, handling, and disposal of biohazardous, toxic, or

radioactive materials.

Safety Symbols and Labels

High Voltage Electric Shock Risk Symbol

This symbol indicates that there is high voltage and there is a risk of electric shock, and the operator should use

care when accessing this area.

Sharp Object Label

This symbol indicates that there are sharp objects, and the operator should use care when accessing this area.

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Safety, Notices and Labels

General Biohazard Symbol

This symbol indicates a possible biohazard risk from patient specimen contamination.

Caution, Biohazard Label

This symbol indicates a caution to operate only with all covers in position to decrease risk of personal injury or

biohazard.

Class 1 Laser Caution Label

A label reading “THIS PRODUCT CONFORMS TO APPLICABLE REQUIREMENTS OF 21 CFR 1040 AT THE DATE OF

MANUFACTURE” is found near the Name Rating tag. The laser light beam is not visible.

RoHS Notices

These labels and materials declaration table (the Table of Hazardous Substance’s Name and Concentration) are to

meet People’s Republic of China Electronic Industry Standard SJ/T11364-2006 “Marking for Control of Pollution

Caused by Electronic Information Products” requirements.

China RoHS Caution Label

This label indicates that the electronic information product contains certain toxic or hazardous substances. The

center number is the Environmentally Friendly Use Period (EFUP) date, and indicates the number of calendar

years the product can be in operation. Upon the expiration of the EFUP, the product must be immediately

CLASS 1 LASER PRODUCT

THIS PRODUCT CONFORMS TO

APPLICABLE REQUIREMENTS OF

21 CFR 1040 AT THE DATE OF

MANUFACTURE.

MANUFACTURED:

726024-C

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