K-Patents PR-23 for K-Patents - Manual (Page 8)

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