K-patents PR-23 for K-Patents Appendix User Manual

Document/Revision No. IM-GB-PR23-AC-VACCINES: Rev. 1.01Effective: November 1, 2013K-Patents Pharma Refractometer PR-23-ACAppendix to PR-23 Instruction

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201310Appendix to the Instructions Manual PR-232.3 Pharma Refractomete

The Pharma Refractometer PR-23-AC2© Copyright K-Patents 2013. All rights reserved.11Figure 2.2 Pharma Refractometer PR-23-AC-62-HSS-EP sensor and Pha

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201312Appendix to the Instructions Manual PR-232.4 Indicating Transmit

The Pharma Refractometer PR-23-AC2© Copyright K-Patents 2013. All rights reserved.13Front view Back view186 mm(7.32”)281 mm(11.06”)153 mm(6.04”)304 mm

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201314Appendix to the Instructions Manual PR-23wireless network (WLAN)

© Copyright K-Patents 2013. All rights reserved.153Installation of PR-23 Pharma Refractometer3.1 Hardware and Software RequirementsPR-23 software is

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201316Appendix to the Instructions Manual PR-23Attaching table top stan

Installation of PR-23 Pharma Refractometer3© Copyright K-Patents 2013. All rights reserved.172Figure 3.2 Sensor stand assembly: Installing the sensor

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201318Appendix to the Instructions Manual PR-234Figure 3.4 Sensor stan

Installation of PR-23 Pharma Refractometer3© Copyright K-Patents 2013. All rights reserved.193.4 Indicating Transmitter installation for use in table

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 20132Appendix to the Instructions Manual PR-23Do not underestimate or n

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201320Appendix to the Instructions Manual PR-233.5 Wiring transmitter

Installation of PR-23 Pharma Refractometer3© Copyright K-Patents 2013. All rights reserved.213.6 Refractometer Instrument VericationThe operational

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201322Appendix to the Instructions Manual PR-23

© Copyright K-Patents 2013. All rights reserved.2344.1 Ethernet connectionIn addition to software operation via the hardware, the DTR can be consider

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201324Appendix to the Instructions Manual PR-23Figure 4.1 Computer Com

Electronic Data Capture and Storage4© Copyright K-Patents 2013. All rights reserved.25displayed at all times. The IP address of the connected refracto

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201326Appendix to the Instructions Manual PR-23CALC is the calculated c

Electronic Data Capture and Storage4© Copyright K-Patents 2013. All rights reserved.27Figure 4.4 Computer Communication Software CC-11: Data logging

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201328Appendix to the Instructions Manual PR-23The log le is not visib

© Copyright K-Patents 2013. All rights reserved.295Complying with Documentation and Validation Regulations5.1 DocumentationWhen a pharmaceutical comp

© Copyright K-Patents 2013. All rights reserved.3ContentsSection 1 K-Patents Products for Vaccine Production and Sucrose Gradient Ultracentrifugati

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201330Appendix to the Instructions Manual PR-235.4 Electronic Data Man

Complying with Documentation and Validation Regulations5© Copyright K-Patents 2013. All rights reserved.315.9 K-Patents Refractometer System Adherenc

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201332Appendix to the Instructions Manual PR-23

© Copyright K-Patents 2013. All rights reserved.336This Installation Qualication (IQ) involves documented verication of the complete system: K-Paten

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201334Appendix to the Instructions Manual PR-236.1.2 Authorized ofcia

Onsite Qualication Protocols and Records: Installation Qualication6© Copyright K-Patents 2013. All rights reserved.356.2.2 Manufacturers and suppli

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201336Appendix to the Instructions Manual PR-236.3.2 DamageDescription

Onsite Qualication Protocols and Records: Installation Qualication6© Copyright K-Patents 2013. All rights reserved.376.5 Operating environmentDescr

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201338Appendix to the Instructions Manual PR-236.7 Setting up the syst

Onsite Qualication Protocols and Records: Installation Qualication6© Copyright K-Patents 2013. All rights reserved.396.8 Electrical connections and

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.01 Effective: November 1, 20134Appendix to the Instructions Manual PR-23Section 6 OnsiteQualicatio

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201340Appendix to the Instructions Manual PR-236.9 Ethernet connection

Onsite Qualication Protocols and Records: Installation Qualication6© Copyright K-Patents 2013. All rights reserved.41Requirement valuesThe correspon

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201342Appendix to the Instructions Manual PR-236.12 Installation Quali

© Copyright K-Patents 2013. All rights reserved.437Onsite Qualication Protocols and Records: Operational QualicationOperational Qualication (OQ) is

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201344Appendix to the Instructions Manual PR-237.3 Test procedureThe O

Onsite Qualication Protocols and Records: Operational Qualication7© Copyright K-Patents 2013. All rights reserved.457.5 System qualicationCheck th

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201346Appendix to the Instructions Manual PR-237.7 Instrument vericat

Onsite Qualication Protocols and Records: Operational Qualication7© Copyright K-Patents 2013. All rights reserved.477.8 Operational Qualication Su

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201348Appendix to the Instructions Manual PR-23Comments (including disc

© Copyright K-Patents 2013. All rights reserved.498After the instrument is qualied, it can be used to measure analytical data. A Standard Operating P

© Copyright K-Patents 2013. All rights reserved.51This Instruction Manual Appendix covers K-Patents Pharma Refractometer PR-23-AC when used in the pro

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201350Appendix to the Instructions Manual PR-23

© Copyright K-Patents 2013. All rights reserved.519The need for K-Patents Pharma Refractometer regular maintenance is minimal, due to the construction

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 201352Appendix to the Instructions Manual PR-23

© Copyright K-Patents 2013. All rights reserved.5310Other DocumentationYou may want to include the following documents in your les concerning this K-

NotesAppendix to the Instructions Manual PR-23Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.0 Effective: March 1, 201354

www.kpatents.comK-Patents OyP.O. Box 77FI-01511 Vantaa, FinlandTel: +358 207 291 570Fax: +358 207 291 577Email: [email protected], Inc.1804 C

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 20136Appendix to the Instructions Manual PR-231.1 Design QualicationD

© Copyright K-Patents 2013. All rights reserved.72The Pharma Refractometer PR-23-AC2.1 System descriptionThe recommended system for the vaccines prod

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 20138Appendix to the Instructions Manual PR-232.2 System components2.2

The Pharma Refractometer PR-23-AC2© Copyright K-Patents 2013. All rights reserved.91132111589107b7a533a142a71264Figure 2.1 System hardware and softwa