Installation Guidance for the Sievers 500 RL0 pages

Fact Sheet
Analytical Instruments

Installation Guidance for the Sievers 500 RL
Aligning the 500 RL TOC Analyzer with Regulatory Expectations and
ASTM Best-practice Standards for On-line TOC Testing
Background

In January 2011, the United States Food and Drug
Administration (FDA) published a Guidance for
Industry document outlining the general principles
and practices of process validation. In this document,
the FDA encourages pharmaceutical manufacturers
to collect and evaluate process data throughout the
product life cycle in an effort to deliver quality product
to the patient. In addition, the cGMP regulations require
analytical devices or equipment, including on-line
TOC instruments, to be installed correctly and suitably
located for their intended use per CFR § 211.63.1
Most on-line TOC instruments are installed for use as
process control and monitoring devices, with final
release samples still being measured off line in the
QC laboratory. Although GE Analytical Instruments’
on-line TOC analyzer customers seek alignment with

current industry guidance, they may miss some critical
elements by using different approaches to installing
instruments for on-line TOC testing. To help standardize
the installation procedure and ensure the instrument
is installed in alignment with regulatory expectations,
GE Analytical Instruments developed a robust 500 RL
installation package. This Fact Sheet provides more
detail regarding the specific elements and offerings
of the Sievers 500 RL On-line TOC Analyzer Installation
Package.

Sievers 500 RL Installation Package Elements

The 500 RL Installation Package includes three critical
components, including Installation Activities, Performance
Verification, and Standard Operating Procedures (SOPs).
Table 1 highlights the 500 RL Installation Package
documentation components and the on-site services
available.

Table 1. 500 RL Installation Package Documentation Components and On-site Services

Critical
Components
Installation Activities

Documentation*
An installation protocol that includes proper
installation of the instrument, firmware,
software, and outputs

On-site Service
Installation Qualification Service

Guidance Procedure for establishing alert and
action limits with on-line TOC analysis
Performance Verification
Standard Operating
Procedures

Recovery Test Procedure of challenge
compounds as defined in FDA guidance
documents and ASTM Standards **
The 500 RL SOP includes instrument and method
information to ensure proper maintenance and
compliant operations after the installation of the
instrument.

Performance Verification
Service of “Specificity” ***
SOP Training & System Overview

* CD includes compatible versions of the documentation files for easy transfer into company specific documents
** ASTM E2656 – Standard Practice for Real-time Release Testing of Pharmaceutical Water for the Total Organic Carbon
Attribute
*** The Sievers Specificity test will challenge the method to recover 500 ppb C Methanol, 500 ppb C Nicotinamide (Vitamin
B3), and 500 ppb C KHP (Potassium Hydrogen Phthalate).