Product Datasheet

Octet System
Qualification
Products andServices

Installation
Qualiﬁcation(IQ)®

Operational
Qualiﬁcation(OQ)

Analytical
Instrument
Qualiﬁcation

Maintenance:
Compliance
Assurance (PMOQ)

Performance
Qualiﬁcation(PQ)

Regulations and global standards, including US FDA 21 CFRPart 11, EU GMP Annex 15 and USP <1058>, require documented verification that your instruments are delivered, installed and routinely calibrated and functioning according totheir operational specifications. Sartorius offers a full line ofqualification products and services to help you meet your initial and ongoing system qualification requirements.

calibrated state and to reduce the risk of using out-ofcompliance systems. We recommend to have instruments
checked and formally tested regularly to confirm they are
working according to manufacturer’s specifications and toidentify possible impacts due to normal wear.

Our Installation and Operational Qualification (IQOQ) andPerformance Qualification (PQ) services verify and record
the instrument’s ability to meet specified criteria after installation, move, software upgrade or major service events. Theseservices include comprehensive testing using establishedconditions and known sample characteristics.

Our comprehensive IQOQ Kit and service includes thefollowing tests performed by certified Sartorius Service
Scientists and Engineers:
Order and System Verification to ensure that theinstrument and computer ordered was received andfully documented
Documentation Verification to ensure that user guides
and other documentation are recorded
Installation Verification to ensure that the installation
meets specifications

Our comprehensive Compliance Assurance (PMOQ) service,
which includes all tests performed during OQ along withadditional light source changes, should be scheduled at
6-month intervals to ensure the system is maintained in a

IQOQ Kits and Services---------

Software Identification Verification to record current versions and verify compatibility
Verify that instrument is installed in a suitable environment for operation
Instrument communication and initialization check
Instrument XYZ stage alignment check
Instrument optical system check
Light source power check
Plate temperature accuracy check
Shaker speed accuracy check
Signal (nm shift) accuracy and reproducibility verification
Baseline drift and RMS noise verification

PQ Kits and Tests

Sartorious PQ Kits* provide a rapid and convenientmethod to verify the performance of Octet® Systems.
Instrument performance qualification can be performed
using one or both of two tightly controlled assays,
depending on the intended use of the instrument. Bothassays make use of a well-characterized antibody-antigen
binding pair.
The PQ-Kinetics Assay Kit (PQ-K) verifies signal levels, signal
precision, kinetic (ka, kd) and affinity (KD) constants are within
specification for an antibody-antigen binding interaction.
The PQ-Quantitation Assay Kit (PQ-Q) verifies signal levels, sample recovery, and precision are within specification
in a two-step binding assay for quantitation.
* PQ products are currently only available for the Octet® RH16, R8 andRED96e Systems.

GermanySartorius Lab Instruments GmbH & Co. KG
Otto-Brenner-Strasse 2037079 Goettingen
Phone +49 551 308 0F
 or further contacts, visit
www.sartorius.com/octet-support

Specifications subject to change without notice.
Copyright Sartorius Lab Instruments GmbH & Co. KG.
For Research Use Only.
DS-41-0294 Rev C

Recommended Frequency
IQOQ
To help ensure optimal performance and to support
instrument compliance, we recommend IQOQ service tobe performed at the following times:
At instrument installation
After major repair or replacement of critical components
After relocation
After functionality is added to the system, such as software upgrades---PMOQ
For instrument calibration purposes, we recommend
PMOQ to be performed on a semi-annual basis. One annual PMOQ service is included in the Compliance Assurance Service Contract for all systems. Additional or standalone PMOQ service can also be purchased separately.
PQ
PQ Kits can be purchased and run by end user at any specified interval – weekly or monthly – based on the quality requirements of your laboratory. Sartorius certified personnel
will run an initial PQ following instrument installation, after
relocation, and after software upgrades. A partial PQ will be
run following a major repair to the instrument.

Comprehensive Service Contracts
Sartorious Comprehensive Service Contract(s) ensure
your instrument is performing optimally with minimal
downtime. Routine maintenance and qualification after
software upgrades and major repair events is included
with every GxP comprehensive service contract.

USASartorius Corporation565 Johnson Avenue
Bohemia, NY 11716
Phone +1 888 OCTET 75
Or +1 650 322 1360