Innovations at INTERPHEX Guide 2022 - 14

Example 2: Online Cleaning Validation for
Real-Time Equipment Release
Current pressures to meet today's production demands are
motivating companies to embrace PAT to realize efficiencies.
Integrating online TOC analysis with cleaning validation
invites operational excellence and lean practices into the
process. Cleaning validation programs must demonstrate
comprehensive cleanliness by testing for defined quality
attributes. TOC and conductivity analysis are commonly
used in cleaning validation applications because of the
accuracy and precision in assessing the general cleanliness
of equipment and processes. Analyzing these quality
attributes online gives real-time data that allow for process
understanding, control, troubleshooting, and optimization.
Integrating TOC analyzers with Clean-In-Place (CIP) skids
enables online cleaning validation. While this integration
necessitates design activities and retrofitting of equipment
to successfully align both a TOC analyzer and CIP skid, it
ultimately leads to greater process efficiencies.
In the FDA guidance document on PAT, manufacturers are
encouraged to embrace online technology to continuously
demonstrate validation, understand the process, and
proactively build quality into products. Online technology
allows for efficiency gains, providing an increased focus on
process improvement opportunities and risk management.
It is possible to fully interface with a CIP skid for real-time cycle
profiling and equipment release in online cleaning validation
or ongoing verification programs. Online configuration
reduces human interaction and eliminates risk of errors in
sampling or lab analysis all while maintaining compliance,
accuracy, and data integrity.
Online cleaning validation offers process understanding,
process control, efficiency gains, and optimization. To make
the most of cleaning validation data, TOC analyzers offer
precise, accurate, and robust data that stands up to data
integrity requirements. With validated and accurate results,
data can be used to make important decisions, release
equipment in real time, troubleshoot, and event optimize the
cleaning process for a facility of the future.
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| Innovations at INTERPHEX 2022
Digitization
As labs approach their digital QC transformation, initial focus
areas often include:
Ë Transitioning away from manual data transcription
Ë Simplifying data management, review, and sharing
across various equipment, technologies, software, and
the Lab Information Management System (LIMS)
Ë Ensuring data integrity
Ë Using real-time data analytics to track trends and prevent
Out-Of-Specification (OOS) results
For critical compendial tests such as testing for TOC,
conductivity, endotoxins, and bioburden, labs are transitioning
to instrumentation and software that are developed with
broader digitization goals in mind, alongside essential data
integrity requirements. Since labs are in different stages of
their digital transformation, equipment and software must
be able to support this evolution.
Global companies with multiple sites often want to align and
be harmonized when it comes to equipment for different
types of testing. Harmonization of technology makes it
much easier to properly align global SOPs and analyze data.
It also makes it simpler to submit global data to regulatory
authorities if all global sites are performing release testing
utilizing the same method.
In labs today, the role of human interaction in terms of
reviewing and signing off on data is required and is very
important in ensuring accurate and non-falsified data. Adding
secondary review of data that can be securely reviewed and
electronically signed off with a timestamp of who reviewed
it and when helps strengthen a lab's data integrity and
adds a layer of eyes. Software programs that securely and
accurately generate results that are not subjective (relying
on human input for a result) lead to better conformance
with tests as there is less room for error. Finally, incorporating
newer technology for QC tests that has integrated, validated
software that is 21 CFR Part 11 compliant can reassure labs
that data will not only be secure, but will provide accurate
and reliable results that can easily be traced. These newer
technologies typically come with more user-friendly software
which makes training and compliance easier.
Innovations at INTERPHEX Guide 2022

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