K-Patents PR-23 for K-Patents Appendix - Manual (Page 6)

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 2013
6
Appendix to the Instructions Manual PR-23
1.1 Design 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 wetted parts materials
comply with the contact-compatibility 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. Meeting the FDA and USP criteria guarantees that
the seal material is acceptable for sanitary process applications and the material, or extracts
from the material will not be harmful to human health. No animal derived ingredients (ADI)
have been used in the machining and polishing processes. The PR-23-AC also meets
the 3A Sanitary Standard and is tested for in-place-cleanability according to the Euopean
Hygienic Engineering Design Group (EHEDG) test.
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 the refractometer generated measurement
and diagnostic data for storage, analysis and reporting. 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 the procedure similar to the one described in the
PROCESS REFRACTOMETER PR-23 INSTRUCTION MANUAL,
Section 13.
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 provides
full traceability of the wetted parts materials. Certificates of Origin, and any other required
quality documentation is available upon request at time of order.
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 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.