K-Patents PR-23 for K-Patents Appendix - Manual (Page 46)

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 2013
46
Appendix to the Instructions Manual PR-23
7.7 Instrument verification with Sample holder and
Refractive Index Liquids
Description of requirements
Refractometer, sample holder PR-1012 and a set of five standard Refractive index
liquids PR-2300 with Cargille Certification are allowed to be settled to laboratory
ambient temperature (between 20-30 °C, 77-86°F) 24 hours prior to commencement of
the qualification.
Requirement acceptance values
Refractometer, sample holder and Refractive index liquids positioned in the laboratory 24
hours prior to verification with the ambient temperature at between 20-30 °C (77-86°F).
Date Signature Pass Conditional Pass Fail
Conditional pass:
Description of requirements
The procedure is done with all five liquids using a sample holder and verification instructions
at PROCESS REFRACTOMETER PR-23 INSTRUCTION MANUAL,
Section 13.
Nominal R.I. values:
● 1.330
● 1.370
● 1.420
● 1.470
● 1.520
Requirement values
The verification results are OK for all samples and acceptance / deviation values (not
more than + 0.0004 of the nominal values) are received for each sample. The Instrument
verification page in the browser for the complete Verification test procedure shows
Verification result: pass.
Failure to meet acceptance values
Terminate the OQ.
Date Signature Pass Conditional Pass Fail
Conditional pass: