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4 pharma validation package, 1 model code, 5 laboratory test cuvette ltc – K-Patents PR-23 for K-Patents User Manual

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

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Appendix to the Instructions Manual PR-23

2.4 Pharma 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.

2.4.1 Model 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

2.5 Laboratory 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