APR Sept/Oct 2023 - 85

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to the libraries on its existing platform were made, and they had an
immediate expansion of capabilities.
MicroSEQ Microbial ID System:
Single source for implementation
toward regulatory compliance
The MicroSEQ Microbial ID System is a high-throughput, comparative
DNA sequencing technology for the accurate identification of bacteria,
fungi, and yeast. MicroSEQ ID uses a genotypic method based on
sequence-based analysis of ribosomal genes in bacteria and fungi. It
supports recommended qualification guidelines from the International
Conference on Harmonization (ICH), the US Pharmacopeia (USP), the
European Pharmacopoeia (EUP), and the Japanese Pharmacopoeia
(JP). As such, it has been adopted by 23 of the top 25 pharmaceutical
companies globally, with 20 having multisite adoptions.
Rapid 5-step implementation
The timeline between purchase and implementation varies
depending on customer availability, with a typical engagement
lasting 10-12 weeks.
Purchase - Customer buys instrument and consulting service
Installation and training - Instrument installed and qualified
by local field service engineer and training provided by a field
application specialist
Project management and documentation approvals - Project
manager engages with customer to guide them through the validation
process
Validation test execution and customer approvals - CSV specialist
executes test plans
Customer implementation - Customer begins microbial identification
The MicroSEQ Rapid Microbial ID System includes PCR and
sequencing kits, a PCR thermal cycler, and the genetic analyzer
with various throughput options (such as the Applied Biosystems™
SeqStudio™ family of genetic analyzers) the MicroSEQ ID software,
and validated bacterial and fungal libraries. For more information,
visit the MicroSEQ page.
Customers have the option to receive support from the time they
purchase the instrument through installation and training, and then
through CSV. Thermo Fisher Scientific has a long history of successful
project management, test execution, documentation, validation, and
customer approvals.
Accurate identification to species level
MicroSEQ ID compares sequenced DNA to proprietary validated
libraries of more than 12,000 known microbial species. A field
application specialist can help customers create their own custom
library to compare an unknown sequence to the database. It creates
reports and phylogenetic trees and provides security, audit, and
e-signature (SAE) compliant reports. This workflow allows an electronic
chain of custody to support data integrity and enables compliance
with 21 CFR Part 11.
Why choose Thermo Fisher Scientific?
Thermo Fisher Scientific offers a complete microbial identification
solution, including instrumentation, assays, software, service, and
support to facilitate regulatory compliance. We offer complete visibility
into the CSV process, project planning, documentation reviews, test
execution, and summary of results to facilitate regulatory compliance
and allow a successful transition into production.
Our
integrated team-project managers, CSV specialists-have
completed hundreds of consulting engagements for clients, in the
process saving them time, money, and compliance headaches.
Be sure to visit the MicroSEQ page to learn more about the platform,
and how the extensive network can help you implement and validate
your microbial identification system.
References
1.
2.
FDA. 2004. Sterile Drug Products Produced by Aseptic Processing - Current Good
Manufacturing Practice: Guidance for Industry. Available from: https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/sterile-drug-productsproduced-aseptic-processing-current-good-manufacturing-practice
FDA.
2003. Electronic Records; Electronic Signatures - Scope and Application: Guidance for
Industry. Available from: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/part-11-electronic-records-electronic-signatures-scope-and-application
3.
FDA.
2019. Data Integrity and Compliance With Drug CGMP - Questions and Answers:
Guidance for Industry. Available
from: https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questionsand-answers
©
2023 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
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APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023