K-Patents PR-23 User Manual

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Appendix to the Instructions Manual PR-23 for K-Patents Products Intended for use in the Pharmaceuticals Industry

K-Patents Pharma Refractometer PR-23-AC

and Laboratory Test Cuvette LTC

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0

Effective: December 15, 2011

Appendix to the Instructions Manual PR-23

Do not underestimate or neglect the laboratory and factory safety rules:

●● Before you start, assess the workplace to determine if hazards are present, or are likely to be present, which necessitate the use of personal protective equipment, e.g.: ●● protective clothing and shoes

●● safety goggles ●● protective gloves

●● respiratory shields and devices

●● Locate the nearest safety equipment, extinguishers, eyewash, and emergency shower

2	Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011

Section 1	K-Patents Products for the Pharmaceutical Industry......................................................			7
	1.1	Design Qualification.......................................................................................................		8
Section 2	The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC.....................			9
	2.1	System description.........................................................................................................		9
	2.2	Use of Laboratory Test Cuvette for validation and sample testing................................		9
	2.3	System components provided by K-Patents................................................................		10
		2.3.1	Checklist of components..................................................................................	10
	2.4	Pharma validation package..........................................................................................		12
		2.4.1	Model code.......................................................................................................	12
	2.5	Laboratory Test Cuvette LTC........................................................................................		12
		2.5.1	Model code.......................................................................................................	12
	2.6	Indicating Transmitter DTR-GP-SC..............................................................................		14
		2.6.1	Model code.......................................................................................................	14
	2.7	Ancillary equipment and materials required, but not supplied by K-Patents...............		15
	2.8	Hardware and Software Requirements........................................................................		16
	2.9	Mechanical and Electrical Requirements.....................................................................		16
	2.10	Sensor installation and system connections................................................................		16
	2.11	Indicating Transmitter DTR assembly for use in Laboratory........................................		17
	2.12	Wiring connections of transmitter to sensor, power cable and computer....................		18
Section 3	Use of PR-23 Pharma Refractometer with Laboratory Test Cuvette LTC:
	Static Sampling...................................................................................................................			19
	3.1	Refractometer Instrument verification..........................................................................		19
	3.2	Laboratory Test Cuvette: Static sampling....................................................................		20
	3.3	Assembly of Laboratory Test Cuvette: Static sampling ...............................................		20
	3.4	Mounting Laboratory Test Cuvette to Sensor..............................................................		21
	3.5	Connecting hoses from thermostatic bath...................................................................		22
	3.6	Sample loading and mixer insertion.............................................................................		23
Section 4	Verification of Laboratory Test Cuvette LTC: Static sampling......................................			25
	4.1	Refractometer and Laboratory Test Cuvette Verification.............................................		25
Section 5	Use of Laboratory Test Cuvette LTC: Continuous sampling.........................................			27
	5.1	Assembly of continuous sampling Laboratory Test Cuvette........................................		27
	5.2	Mounting Laboratory Test Cuvette to Sensor..............................................................		28
	5.3	Connecting hoses.........................................................................................................		28
	5.4	Interconnection of all system parts...............................................................................		29

Appendix to the Instructions Manual PR-23

Section 6	Complying with Documentation and Validation Regulations........................................		31
	6.1	Documentation.............................................................................................................	31
	6.2	Qualification..................................................................................................................	31
	6.3	Protocol Acceptance by Customer and List of Tests Performed.................................	32
	6.4	Electronic Data Management and Data Storage.........................................................	32
	6.5	Electronic Signatures/Audit Trail..................................................................................	32
	6.6	Record Keeping............................................................................................................	32
	6.7	Security.........................................................................................................................	32
	6.8	System Validation.........................................................................................................	33
	6.9	K-Patents Refractometer System Adherence to Part 11..............................................	33

Section 7	Onsite Qualification Protocols and Records: Installation Qualification......................			35
	7.1	Authorization and responsibilities................................................................................		35
		7.1.1	Documents and procedures.............................................................................	35
		7.1.2	Authorized officiator..........................................................................................	36
		7.1.3	Execution..........................................................................................................	36
	7.2	System..........................................................................................................................		36
		7.2.1	Qualifying the system.......................................................................................	36
		7.2.2	Manufacturers and suppliers............................................................................	37
	7.3	IQ Protocol....................................................................................................................		37
		7.3.1	Scope of delivery..............................................................................................	37
		7.3.2	Damage............................................................................................................	38
	7.4	Documentation.............................................................................................................		38
	7.5	Operating environment.................................................................................................		39
	7.6	Installation....................................................................................................................		39
	7.7	Setting up the system components and devices..........................................................		40
	7.8	Electrical connections and wiring.................................................................................		41
	7.9	Ethernet connection.....................................................................................................		42
	7.10	Initial check and switching the device on ....................................................................		42
	7.11	Installation Qualification Summary Report..................................................................		43

Section 8	Onsite Qualification Protocols and Records: Operational Qualification.....................		45
	8.1	Individual module and system components check.......................................................	45
	8.2	Installation Qualification has been performed successfully.........................................	45
	8.3	Test procedure..............................................................................................................	46
	8.4	Authorized officiator.....................................................................................................	46
	8.5	System qualification.....................................................................................................	47
	8.6	Setting up the system components and devices..........................................................	47
	8.7	Instrument verification with Sample holder and Refractive Index Liquids...................	48
	8.8	Instrument verification with Laboratory Test Cuvette for Static sampling and
		Refractive Index Liquids...............................................................................................	49
	8.9	Operational Qualification Summary Report.................................................................	50

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Contents

Section 9	Analytical Method Validation: Establishing product refractive index monitoring
	validation protocols............................................................................................................		53
	9.1	Validation of Analytical Method....................................................................................	53
	9.2	Protocol objectives.......................................................................................................	54
Section 10	Routine Operation Phase...................................................................................................		55
Section 11	Preventive Maintenance.....................................................................................................		57
	11.1	Spare parts...................................................................................................................	57
Section 12	Other Documentation.........................................................................................................		59

Appendix to the Instructions Manual PR-23

6	Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011

1 K-Patents Products for

the Pharmaceutical Industry

This Instruction Manual Appendix covers K-Patents Pharma Refractometer PR-23-AC, and the Laboratory test cuvette LTC. Using these allows accurate measurements of liquid concentration to be obtained in compliance with pharmaceutical industry requirements.

Validation of an analytical method is the process, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical applications. The Laboratory test cuvette LTC is designed as an additional off-line testing and validation tool for use with the Pharma Refractometer PR-23-AC.

Qualification is a subset of the validation process that verifies the Pharma Refractometer instrument performance before it is placed in-line in a regulated environment (Figure 1.1). System suitability tests are used to verify that the accuracy, repeatability and reproducibility of the refractometer are adequate for the analysis to be performed. After all qualification checks have been performed and the required validation standards have been met, the Pharma Refractometer can then be installed in the production process for in-process control.

DESIGN	INSTALLATION	OPERATIONAL	PERFORMANCE
QUALIFICATION	QUALIFICATION	QUALIFICATION	QUALIFICATION

TIMING AND APPLICABILITY

Prior to purchase of a new model of instrument

At installation of each	After installation or major	Periodically at specified
instrument (new, old or	repair of each instrument	intervals for each
existing unqualified)		instrument

	EXAMPLE ACTIVITIES
Assurance of	Description	↔ Fixed parameters			Preventive maintanance
manufacturer’s DQ					and repairs
Assurance of adequate	Instrument delivery		Verify calibration and		Establish practices
support availability from	(Instrument, manuals etc.)		accuracy Validation		to address operation,
manufacturer					calibration, maintenance
					and change control
Preliminary instrument	Utilities/Facility	↔ Environment
performance valuation	(are prerequisites met?
(fitness for purpose)
	Assembly and installation	← Secure data storage,
	Network and data storage	→ back up and archive
	Installation verification	↔ Instrument function test		↔ Performance checks
	(initial testing after
	installation before
	operational qualification)

Figure 1.1 Qualification process steps.

Appendix to the Instructions Manual PR-23

1.1Design Qualification

Design Qualification (DQ) typically consists of manufacturer’s documentation to verify that the proposed design of the K-Patents Refractometer is suitable for the intended purpose.

K-Patents Pharma Refractometer PR-23-AC is an in-line real-time instrument that is designed to meet the pharmaceutical industry standards and guidelines including PAT, GMP, CIP/SIP and validation. K-Patents Pharma Refractometer PR-23-AC fulfills the pharmaceutical drug production regulations for process wetted part materials, sealing, and surface roughness. No animal originated media are used in the machining and polishing processes. The model PR-23-AC meets the 3-A Sanitary Standard requirements and is EHEDG (European Hygienic Equipment Design Group) tested.

The K-Patents refractometer has an Ethernet communications solution. The transmitter uses the IP protocol to communicate over the Ethernet to any type of computer. This eliminates human error and allows for easy capture of refractometer generated measurement and diagnostic data for storage, analysis and reporting. K-Patents provides a software package for data downloading. Full software specifications are freely available to users who wish to develop their own communications program. Access to the refractometer and the generated data can be restricted to authorized personnel using password and padlock protection.

K-Patents refractometers are designed, manufactured and serviced under ISO 9001 quality system and procedures that guarantee the accuracy and repeatability of the measurement results. Each refractometer sensor is provided with a calibration certificate comparing

a set of standard liquids to the actual sensor output. K-Patents verifies the calibration of all delivered instruments according to a procedure similar to the one described in the PROCESS REFRACTOMETER P2-23 INSTRUCTION MANUAL, Section 13.

K-Patents Pharma Refractometer PR-23-AC wetted parts materials comply with the contactcompatibility of a substance with pharmaceutical materials. Gasket materials conform to the FDA requirements 21 CFR 177.2600 and to biocompatibility standards according to USP Class VI.

K-Patents has an ISO 9001 certified quality system, which covers all its functions. The quality system is ISO 9001 certified by Det Norske Veritas. The quality performance is improved by critical self-assessment, internal auditing and feedback system. The chain of quality starts from the subcontractors with whom K-Patents maintains a quality contracting and regular auditing system. The internal quality functions, from verification of incoming products to packing and delivery, are based on defined procedures.

K-Patents Process Refractometers and support services are available to customers anywhere in the world. Application, installation and technical assistance are provided both locally by the representatives and also by the headquarters in Finland and the branch in the U.S.

K-Patents warrants that all products made by K-Patents shall be free of defects in material and workmanship. K-Patents agrees either to replace or repair free of charge, any such product or part thereof which shall be returned to the nearest authorized K-Patents repair facility within two (2) years from the date of delivery.

8	Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011

The Pharma Refractometer

2 PR-23-AC with Laboratory Test Cuvette LTC

2.1System description

The system comprises of a Pharma Refractometer PR-23-AC unit, a Laboratory Test Cuvette LTC, a computer for data logging and a microprocessor controlled thermostat. A thermostatic water bath is used to accurate and reliable temperature regulation of the liquid sample concentration in the Laboratory Test Cuvette during the off-line laboratory measurements. With this temperature control system the temperature of the Lab Test Cuvette test sample can be accurately adjusted and maintained.

2.2Use of Laboratory Test Cuvette for validation and

sample testing

Any significant change in a process of making a pharmaceutical product is a regulatory concern. Postapproval changes in the size of a batch from the pilot scale to larger or smaller production scales call for submission of additional information in the application to the Food and Drug Administration (FDA), with a specific requirement that the new batches are to be produced using similar test equipment and in full compliance with GMPs and the existing SOPs.

Manufacturing changes may also require new stability and dissolution testing. This is especially true for equipment changes (change to equipment of a different design and different operating principles) and the process changes (e.g. in mixing times and operating speeds). The Laboratory Test Cuvette LTC with static sample feature can be used to further study the sample characteristics. For instance the concentrations of the samples can be tested in varied conditions, e.g. in accelerated, elevated temperature tests.

Also, the preparation of the laboratory pilot batch is required many times as an intermediate step in a scale-up process. The Laboratory Test Cuvette LTC with the continuous sampling feature is designed for testing samples in a laboratory pilot batch.

The benefit of K-Patents Pharma Refractometer with the Laboratory Test Cuvette is that it allows the use of the same equipment in all test faces as well as in the full scale on-process stage (see Figure 2.1).

Appendix to the Instructions Manual PR-23

From Lab to Commercial Production

Laboratory-scale		Laboratory pilot-scale		Full scale production
	batches		batches

Off-line

In-

Process optimization and scale-up

Figure 2.1 Test and validation equipment from laboratory to commercial production.

2.3System components provided by K-Patents

2.3.1Checklist of components

1 Pharma Refractometer PR-23-AC-62-HSS calibrated with raw measurement data refractive index (nD) and temperature (T)

2 Indicating transmitter DTR-M/U-GP-SC that calculates and displays the process liquid

2a concentration based on the refractive index and temperature, installed in a stainless steel enclosure that contains a key

3 Table top stand PR-7603-SS for Indicating transmitter, contains a set of two

3a M5x10 A2 DIN 912 screws

4 Wall mounting screws kit for mounting the Indicating transmitter DTR on the wall

5 Interconnecting cable between transmitter and sensor PR-8230

6 PR-8820 Crossover cable for Ethernet connection between Indicating transmitter and computer, length 5 m (16 inch), contains cable gland for enclosure connection

7 Outer casing of Laboratory Test Cuvette LTC-HSS

8 PR-9254 O-ring, 21x2 EPDM

9 Compression spring

10 Sample chamber, static sampling

11 PR-9253 O-ring, 20.2x3 EPDM

12 Sample chamber, continuous sampling

13 2.5” EPDM sanitary gasket

14a 2.5” Sanitary Clamp for the Laboratory Test Cuvette

14b 2.5” Sanitary Clamp for the Pharma Refractometer PR-23-AC-62-HSS Sensor

15 PR-12151 Sample mixer

16 PR-12152 Mixer paddles, set includes 2 paddles

17 PR-10956 Universal power adapter for Sample mixer

18 Sample holder PR-1012

19 R.I. Liquid set PR-2300, consists of Cargille Certificate for the liquids

20 Memory stick with PR-23 Toolkit program PR-8890 (a standalone software that allows data logging via a cross-over Ethernet cable)

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The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC

	4	16	2
		16
		8
3a	2	7
	2	7
		9
		10
	2a	11
		12

	14b
20	14a
6	14a
	13
5	1

19	18

Figure 2.2 System hardware and software components provided by K-Patents.

Appendix to the Instructions Manual PR-23

2.4Pharma validation package

Pharma validation package PR-12150 contains parts for usage of K-Patents Pharma Refractometer for off-line testing and validation in a laboratory.

2.4.1Model code

PR-12150 Pharma validation package, consisting of:

●● R-7603-SS Table top stand for Indicating transmitter (contains a set of two M5x10 A2 DIN screws)

●● PR-8820 Crossover cable for Ethernet connection between Indicating transmitter and computer, length 5 m (16 inch)

●● Parts for off-line instrument verification:

PR-1012 Sample holder

PR-2300 R.I. liquid set 5 x ¼ fl.oz.; Including: 1,33; 1,37; 1,42; 1,47; 1,52

●● USB Memory stick with PR-23 Toolkit program PR-8890 (a standalone software that allows data logging via a cross-over Ethernet cable)

●● IM-GB-PR23-ACP IQ and OQ Documentation for Equipment qualification

2.5Laboratory Test Cuvette LTC

K-Patents Laboratory Test Cuvette LTC is designed for off-line testing of Pharma Refractometer PR-23-AC in a laboratory in making small quantities of the drug. The

Laboratory Test Cuvette contains parts for static sampling (Figure 2.3) and continuous sampling (Figure 2.4).

Materials for wetted parts on the Laboratory Test Cuvette LTC are: PVDF, 316L Stainless steel, Viton, and EPDM. Materials for wetted parts of the PR-23-AC-62-HSS sensor are:

316L Stainless steel, PTFE Teflon and Sapphire.

2.5.1 Model code

Model and Description	Part No.
LTC = Laboratory Test Cuvette	LTC
Sensor connection
-H = Sanitary 3A-clamp, 2 ½ inch	-H
Material of Construction
SS = AISI 316	SS

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The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC

Mixer

Outer casing

8mm (0.35”) cooling/heating water OUTLET

O-ring	2
16x2 EPDM

O-ring

21x2 EPDM

8mm (0.35”)	Sample chamber
cooling/heating
water INLET
	O-ring
	20.2x3 EPDM
EPDM sanitary
gasket

Figure 2.3 Pharma Refractometer PR-23-AC-62-HSS sensor with Laboratory Cuvette LTC for static sampling; dimensions (mm/in).

6mm (0.31”) sample INLET

	6mm (0.31”)
Outer casing	sample OUTLET
Outer casing

8mm (0.35”) cooling/heating water OUTLET

8mm (0.35”) cooling/heating water INLET

O-ring

21x2 EPDM

Sample chamber

O-ring

20.2x3 EPDM

EPDM sanitary gasket

Figure 2.4 Pharma Refractometer PR-23-AC-62-HSS sensor with Laboratory Cuvette LTC for continuous sampling; dimensions (mm/in).

Appendix to the Instructions Manual PR-23

2.6Indicating Transmitter DTR-GP-SC

The Indicating transmitter DTR is a specialized computer designed to process data received from one or two refractometer sensors. The Indicating transmitter (Figure 2.5) contains a front panel with a backlit Liquid Crystal Display (LCD) and a keyboard. A lock and a key are included in the enclosure’s door to prevent unauthorized access.

Materials for the Pharma Indicating Transmitter Enclosure DTR-M/U-GP-SC are: Stainless Steel, and polycarbonate window.

2.6.1 Model code

Model and Description		Model
DTR = Indicating Transmitter (connectivity for two sensors)		DTR
STR = Indicating Transmitter (connectivity for one –IA/-IE sensor)		STR
Cable connection
-U = ½ inch NPT-type conduit hubs		-U
-M = M20x1,5 metric cable glands		-M
Electrical classification
-GP = General purpose		-GP
Enclosure
-SC = Stainless Steel enclosure with window		-SC
Transmitter options (A) (leave this section blank, if AC supply is specified)
-DC = Power supply 24 V DC		-DC
(A) Note standard power supply is 100-240 VAC 50/60 Hz
Front view	Back view
153 mm
(6.04”)

186 mm (7.32”)

304 mm (11.95”)

281 mm (11.06”)

45 mm (1.77”)

50 mm

(1.97”) 50 mm (1.97”)

254 mm (9.99”)

Figure 2.5 Indicating transmitter DTR-GP-SC with Stainless steel enclosure; dimensions (mm/in).

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The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC

2.7Ancillary equipment and materials required, but not supplied by K-Patents

1 Any type of computer (PC, Mac, PDA, or mainframe)

2	Power cables, Optional: External power switches	2

3	Thermostatic bath and closed-looped circulator for precise temperature control of samples

4	Cooling water or non-aqueous cooling/heating fluid (silicon and other oil,

	glycol mixture, etc.).

5 Water hoses (inner dia. 8 mm/0.3 inch) to connect LTC to thermostatic bath.

Optional: Ball valves with hose fittings at both ends for opening and closing the water supplies to the laboratory cuvette between the cleansing and test sessions

6 Optional: 2 Ball valves for shutting off thermostatic fluid flow

7 Pipettes for static sampling

8 Continuous sample delivery system with sample delivery pump or peristaltic pump for sucking the sample

9 ID 6 mm (0.23 inch) sampling hose between continuous sampling LTC and test supply system

10 Cleaning tissue

11 Optional: Distilled water

12 Cleaning agent, e.g. Isopropyl Alcohol (IPA)

13 DIN 911 Long arm hexagon key (N:o 4) for opening and closing the socket screws of

DTR support

3 1

	7
13	5	6
2	5	6
9	8
9

Figure 2.6 Ancillary equipment and materials required, but not supplied by K-Patents.

Appendix to the Instructions Manual PR-23

2.8Hardware and Software Requirements

PR-23 software is included in the Indicating Transmitter DTR and it includes: ●● Automatic temperature compensation

●● Sensor diagnostics and verification

In addition to software operation via the hardware, the DTR can be considered a web server and is accessible via web-browser (e.g. Internet Explorer, Mozilla, Firefox etc.). The Ethernet connection enables data download from an Indicating transmitter DTR to a computer. The connection works both directly between DTR and computer, or via a hub or switch, local area network (LAN), wireless network (WLAN) or fiber Ethernet. Any type of computer

(PC, Mac, PDA, mainframe...) with a compatible network connection can be configured to download data from the DTR. See PROCESS REFRACTOMETER INSTRUCTION MANUAL, Section 12 for detailed instructions.

2.9Mechanical and Electrical Requirements

Power supply for the refractometer is AC input 100-240 VAC/50-60 Hz, optional 24 VDC,

30VA.

2.10Sensor installation and system connections

Laboratory installation and key considerations for the site preparation

1.Physical dimensions of the instrument and accessories: Make sure there is enough space to accommodate them.

2.Suitable recommended operational environment for the instrument and for the Cargille Refractive Index Liquids should be maintained between 20 – 30 °C (68 – 86°F).

3.Utilities: 100-240 VAC/50-60 Hz (optional 24 VDC, 30 VA) electrical power supply, computer network connection, fume hood if required and water supply.

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The Pharma Refractometer PR-23-AC with Laboratory Test Cuvette LTC

2.11 Indicating Transmitter DTR assembly for use in Laboratory

Attaching laboratory stand to DTR

Unlock and open the DTR cabinet door, then unscrew the retaining screw for the keypad

panel and open the panel. The supplied screws (M5x10 A2 DIN 912) for attaching the stand 2 are inserted from the inside through the top two holes located at the back of the cabinet.

These are aligned and screwed into the threaded attachment points located at the top of the stand. The enclosure can now be used as a free standing tabletop unit, see Figure 2.7.

Figure 2.7 Attaching the laboratory table top stand to the Transmitter for use in the laboratory.

Appendix to the Instructions Manual PR-23

2.12 Wiring connections of transmitter to sensor, power cable and computer

For Indicating transmitter DTR wiring and Ethernet connections instructions see PROCESS REFRACTOMETER PR-23 INSTRUCTION MANUAL, Section 3 and Section12. When the wiring connections have been made sensor calibration and verification can commence.

Indicating Transmitter

DTR-M-GP-SC

Interconnecting cable

PR-8230

Pharma Refractometer

PR-23-AC-62-HSS

Power Supply Cable (not supplied by K-Patents)

Crossover Cable

PR-8820

PC -Windows

(not supplied by K-Patents)

Figure 2.8 Connection diagram for sensor calibration verification.

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Use of PR-23 Pharma Refractometer 3 with Laboratory Test Cuvette LTC:

Static Sampling

3.1Refractometer Instrument verification

The operational procedure checking the refractometer calibration’s accuracy, linearity and short-term repeatability and reproducibility consists of verification tests using Cargille standard Refractive index nD liquids.

The verification of the refractometer calibration is performed whenever a new K-Patents Laboratory Refractometer is qualified as a part of the validation process, and also if any of the following occurs:

●● There is a replacement of optical parts (Prism and prism gasket).

●● Refractometer readings reflect an unusual shift, or are outside of the acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.

Verification should be performed once every 6 months (or more frequently if specified in the client’s own quality system) as a routine quality control check. Verification is carried out using the Sample Holder PR-1012 and the set of Cargille standard refractive index nD liquids. A set (R.I. Liquid set PR-2300) is supplied by K-Patents. The Sample Holder PR 1012 consists of a sample receptacle with O-ring seal around the bottom aperture.

Before commencing the verification process make sure that your Refractometer and sample holder are at normal room temperature. Preferably take all components in the laboratory already one day prior to the verification. Check the condition and expiry date of your

Standard Refractive Index Liquids and that you also have the required cleaning solution (e.g. Isopropyl alcohol) and cleaning tissue to clean the sensor wetted surfaces and the sample holder.

For full Sensor verification instructions see PROCESS REFRACTOMETER PR-23, INSTRUCTION MANUAL Section 13.

After verification of the PR-23 sensor, further verification of the Laboratory Test Cuvette and

Sensor combination can be carried out.

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