微生物空气取样IQ、OQ(英文版)-higmp之家

Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.00 Effective Date: 21/01/2009 1 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/2008 MicroBio MB1 IQ/OQ/PQ Installation, Operational and Performance Qualification Protocol and Report for the MicroBio MB1 Air Sampler Document No: P0001W004 Issue: 1.01 Date: 05 March 2009 Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 2 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 © Cantium Scientific Limited 2009 All rights reserved. No part of this publication may be reproduced in any material or electronic form without the written permission of the copyright holder except in accordance with the provisions of the Copyright, Designs and Patents Act 1988. The material within this document should be considered strictly confidential and may only be disclosed to those mentioned within the distribution list or others as agreed with the copyright holder. Printed versions of this document are considered as uncontrolled. The latest version is always held electronically on the company’s computer network in the project, business or quality system folder, where appropriate. Cantium Scientific Limited 15 Clarendon Gardens Dartford Kent DA2 6EY Tel: +44 (0) 1322 252000 Fax: +44 (0) 1322 253253 Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 3 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 1 Contents 1 Contents ...................................................................................................................................................................... 3 2 Document Approval ............................................................................................................................................... 4 3 Document Issue ....................................................................................................................................................... 5 4 Distribution ............................................................................................................................................................... 5 5 Abbreviations ........................................................................................................................................................... 5 6 References .................................................................................................................................................................. 5 7 Introduction .............................................................................................................................................................. 6 8 Document Scope ...................................................................................................................................................... 6 9 Responsibilities........................................................................................................................................................ 6 10 Appendices ........................................................................................................................................................... 7 10.1 Appendix 1: Plant Description ................................................................................................................ 8 10.2 Appendix 2: Technical Information ...................................................................................................... 9 10.3 Appendix 3: Equipment Schematic .................................................................................................... 10 10.4 Appendix 4: IQ/OQ/PQ Rationale ...................................................................................................... 11 10.5 Appendix 5: Critical Instrument/Device Rationale ..................................................................... 12 10.6 Appendix 6: Critical Instrument/Device List ................................................................................. 13 10.7 Appendix 7: Operating and Maintenance Manuals ..................................................................... 14 10.8 Appendix 8: Spare Parts, Expendables and Consumables ....................................................... 15 10.9 Appendix 9: Procedures / Use Logs / Forms ................................................................................. 16 10.10 Appendix 10: Risk Assessments ................................................................................................... 17 10.11 Appendix 11: IQ Protocol – Equipment Installation ........................................................... 18 10.12 Appendix 12: IQ Protocol – Equipment List ........................................................................... 19 10.13 Appendix 13: IQ Protocol – Devices Calibrated .................................................................... 20 10.14 Appendix 14: IQ Protocol – Software Installation ............................................................... 21 10.15 Appendix 15: OQ Protocol – MicroBio MB1 Air Sampler .................................................. 22 10.16 Appendix 16: PQ Protocol – MicroBio MB1 Air Sampler .................................................. 23 10.17 Appendix 17: Test Equipment List ............................................................................................. 24 10.18 Appendix 18: Qualification Summry ......................................................................................... 25 Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 4 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 2 Document Approval Author: Fay Curd ACQI Lead Auditor, Cantium Scientific Limited Signed: Date: 05/03/2009 Approved: Stephen Plumridge BEng (Hons) CEng MIET MIEEE MRI FRSA Director, Cantium Scientific Limited Signed: Date: 05/03/2009 Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 5 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 3 Document Issue Issue Description Date Revision By Approved 1.00 First Issue 21/01/2009 Fay Curd Steve Plumridge 1.01 Minor Corrections 05/03/2009 Steve Plumridge Fay Curd 4 Distribution Recipient Title Company Contact No. Stephen Plumridge Director Cantium Scientific Limited 01322 252252 Fay Curd Quality Lead Auditor Cantium Scientific Limited 01322 252004 Dr Fred Parrett Director F W Parrett Limited 020 8460 2116 MB1 End Users (Uncontrolled / upon request) 5 Abbreviations IQ - Installation Qualification OQ - Operational Qualification PQ - Performance Qualification MB1 - MicroBio MB1 Portable Air Sampler 6 References P0001W002 - MicroBio Calibration Methodology, Issue 2.00, 25/11/2008, by Cantium Scientific Limited P0001W003 - MicroBio Operating Manual, Issue 2.00, 05/03/2009, by Cantium Scientific Limited Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 6 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 7 Introduction This document describes an IQ/OQ/PQ template for use with the MB1 as sold by F W Parrett Limited of Bromley, Kent, United Kingdom, or its distributors worldwide. The various document templates are detailed in the appendices of this document and relate to the following topics: 1. Pant Description 2. Technical Information 3. Equipment Schematic 4. IQ/OQ/PQ Rationale 5. Critical Instrument / Device Rationale 6. Critical Instrument / Device List 7. Operating and Maintenance Manuals 8. Spare Parts, Expendables and Consumables 9. Procedures / Use Logs / Forms 10. Risk Assessments 11. IQ Protocol – Equipment Installation 12. IQ Protocol – Equipment List 13. IQ Protocol – Devices Calibrated 14. IQ Protocol – Software Installation 15. OQ Protocol 16. PQ Protocol 17. Test Equipment List 18. Qualification Summary 8 Document Scope This document relates only to the MB1 sampler as sold by F W Parrett Limited or one of its appointed distributors. The document is intended as a template and it may be used as is or adapted to suit the end users exact requirements. 9 Responsibilities Cantium Scientific Limited is responsible for the production and maintenance of this procedure on behalf of F W Parrett Limited. F W Parrett Limited is responsible for distributing this procedure to its customers upon request. The end user of the MB1 is responsible for the use implementation of the protocols in accordance with their own procedures. Cantium Scientific Limited and or F W Parrett Limited cannot assume responsibility for the end use of this document. Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 7 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 10 Use of This Document The IQ/OQ/PQ documentation contained in the appendices may be used as is or copied and modified to suit the end users requirements. Areas highlighted within the appendices are to be completed by the distributors and end users of the equipment. 11 Appendices The following appendices provide the templates: 1. Equipment Description 2. Technical Information 3. Equipment Schematic 4. IQ/OQ/PQ Rationale 5. Critical Instrument / Device Rationale 6. Critical Instrument / Device List 7. Operating and Maintenance Manuals 8. Spare Parts, Expendables and Consumables 9. Procedures / Use Logs / Forms 10. Risk Assessments 11. IQ Protocol 12. OQ Protocol 13. PQ Protocol The text highlighted in yellow within the appendices should be changed by the distributor or end user to suit their requirements. Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 8 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.1 Appendix 1: Equipment Description EQUIPMENT DESCRIPTION QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Introduction / Plant Description The MB1 and MB2 MicroBio air samplers The MB1 and MB2 MicroBio air samplers are the most economical samplers in the world for monitoring airborne micro-organisms or bioaerosols. They have been fully validated by the UK Department of Trade and Industry Validation of Analytical Methods programme to meet the standards required for a reference sampler. These samplers collect airborne micro-organisms by drawing a stream of air at a constant flow rate of 100 litres per minute through a series of 1mm holes in a metal head. The air stream then impinges onto a sterile culture medium in a 55mm contact plate or 90mm Petri dish. After exposure to the air stream for a fixed period the contact plate is removed and incubated. The numbers of colonies which develop are counted enabling a calculation to be made of the concentration of micro- organisms in the air (CFU/m3 - colony forming units per cubic metre). Key Features · Microprocessor controlled · Flow rate 100 litres/min, factory calibrated · Sampling volume 25 to 1500 litres · Lightweight (700g) and portable · Battery Powered - rechargeable or alkaline · NiMh (4xAA) cells and charger supplied · Dimensions: Case-196x100x40mm black ABS plastic, exc. attached sampling head · Low Battery indication · Low noise · Sample up to 30,000 litres (MB1) · Fully validated to UK DTI VAM programme · Uses inexpensive 90mm Petri or 55mm contact plates · Easy to calibrate · Each unit calibrated prior to shipment and calibration certificate provided · Supplied with 1 Stainless Steel sampling head and spring adaptors for 90mm and 55mm plates · Supplied with MicroBio PC Reporter software · Designed and Manufactured under ISO 9001:2000 quality systems Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 9 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.2 Appendix 2: Technical Information TECHNICAL INFORMATION QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Flow Rate: 100 l/min Sample Volume: 25 to 1500 litres in 14 preset steps Sampling Volume Capacity: Up to 30,000 litres before recharge* Other Features:  Auto switch off  4-digit 7-seg LED display  Sample cancel feature Weight (excluding charger and carry bag): 650g Dimensions: 196 x 100 x 110 mm (inc. sampling head) 196 x 100 x 40 mm (case only) Power: 4 x AA Cells Alkaline or NiMh 6V at 350mA (maximum) Noise Level: < 45dB @ 1m Environmental Operating Range: -10 to 40°C up to 90% RH Sampling Plate Capacity: 55mm contact plate or 90mm Petri dish Sampling Head: 316 grade stainless steel 220 holes of 1 mm diameter over a 50mm diameter area PC Software: Any Windows PC running Windows 2000, XP and Vista Minimum Requirements: Pentium II 3 M Byte hard disk space 256 M Byte RAM 800 x 600 Screen Resolution CD/DVD ROM for installation * Based upon random volume samples at varying intervals until low battery warning given. These tests were done on units fitted with new and fully charged NiMh cells. Actual battery life may vary due to volume taken per sample, interval between samples, age of cells, and other environmental effects such as humidity and temperature. Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 10 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.3 Appendix 3: Equipment Schematic EQUIPMENT SCHEMATIC QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Equipment Name MicroBio Air Sampler Equipment Number Equipment Model Number MB1 Equipment Serial Number Equipment supplier Address Telephone Number Email Contact Name Manufacturer F W Parrett Limited. Address 7 Coppergate Close BROMLEY Kent BR3 Telephone Number +44 (0)20 8460 2116 Email sales@parrett.uk.com Contact Name Dr Fred Parrett, Director Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 11 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.4 Appendix 4: IQ/OQ/PQ Rationale IQ/OQ/PQ Rationale QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Scope / Rationale Installation and Operation Qualification will ensure that the MB1 air sampler is performing as intended and supplied to {CUSTOMER NAME}. Installation Qualification will demonstrate that the equipment has been installed as per specification. The Operational/Performance Qualification will demonstrate that results delivered and activities performed are as per {CUSTOMER NAME} requirements. MB1 air sampler The MB1 air sampler equipment has classified critical devices upon it; these critical devices will be challenged as part of the Operational Qualification. Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.00 Effective Date: 21/01/2009 12 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/2008 11.5 Appendix 5: Critical Instrument/Device Rationale Critical Instrument/Device Rationale QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Equipment Reference Number Device Description Critical Rationale for Classifying Instrument/Device as Critical Sampling Head Critical 316 grade stainless steel 220 holes of 1 mm diameter over a 50mm diameter area Signed: Date: Signed: Date: Checked By: Performed By: Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 13 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.6 Appendix 6: Critical Instrument/Device List Critical Instrument/Device List QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Reference Number Device Description Calibrated Production Challenge or QA Challenge Instrument Range Tolerance MB1 air sampler Flow rate 100 l/min ±3% Signed Date Performed By: Signed Date Checked By: Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.00 Effective Date: 21/01/2009 14 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/2008 11.7 Appendix 7: Operating and Maintenance Manuals Operating and Maintenance Manuals QA Protocol Ref: xxxxxxxx Plant/Equipment/Facility Description: MB1 MicroBio air sampler Manual Title/Reference Location MicroBio Operating/Technical Manual http://mb1manual.cantiumscientific.com/index.html MicroBio Operating/Technical Manual Cantium Scientific Document Number: P0001W003 Signed: Date: Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 15 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.8 Appendix 8: Spare Parts, Expendables and Consumables Spare Parts, Expendables and Consumables QA Protocol Ref: xxxxxxxx This list contains details of all parts that may be considered consumable or spare parts that may be replaced by the end user. Plant/Equipment/Facility Description: MB1 MicroBio air sampler Full Part Description (including sizes where appropriate e.g. bearings, belts etc.) Supplier/Manufacturer Supplier's Part No 4 x AA NiMh high capacity cells (or you may use similar NiMh, NiCd, or even non-rechargeable Alkaline Batteries). Any battery Supplier - Charger and battery pack Cantium Scientific Ltd or F W Parrett Limited P0001BAT001 Stainless Steel Sampling Head Cantium Scientific Ltd or F W Parrett Limited P0001M010 Petri Dish Holding Springs Cantium Scientific Ltd or F W Parrett Limited P0001M008 Contact/RODAC plate holding springs Cantium Scientific Ltd or F W Parrett Limited P0001M007 M3 x 6 stainless steel screws for above springs Cantium Scientific Ltd or F W Parrett Limited P0001SCR003 Signed: Date: Cantium Scientific Limited MicroBio MB1 IQ/OQ/PQ [P0001W004] Issue 1.01 Effective Date: 05/03/2009 16 / 25 QMF24.dotx Issue 2.03 Effective Date: 10/11/200 11.9 Appendix 9: Procedures / Use Logs / Forms Procedures / Use Logs / Forms QA Protocol Ref: xxxxxxxx List all new or existing {CUSTOMER} documentation that impacts upon operation of this equipment. Plant/Equipment/Facility Description: MB1 MicroBio air sampler Document Title Document Ref. Status (draft/final) Date Issued MicroBio Calibration Methodology P0001W002 Final 25/11/2008 MicroBio Operation Manual P0001W003 Final 25/11/2008 The signature below verifies that all required SOPs and