Anne Weeks - Senior Field Marketing Manager BioMonitoring, MilliporeSigma, Burlington, MA USA. An affiliate of Merck, KGaA Darmstadt, Germany; Dr. Anne-Grit Klees - Lead Expert, Product & Portfolio Manager, BioMonitoring Environmental Monitoring, Merck KGaA, Darmstadt, Germany.
Microbiological environmental monitoring (EM) can be complex, generating hundreds or even thousands of sample data points every week. Despite this, many facilities still base their data management on a combination of paper documents, spreadsheets, and digital tools to support individual monitoring methods. As long as QC staff are acquainted with all the intricacies of their particular setup and given the considerable time required to manage their data in compliance with regulations, routine monitoring can be performed this way. But there are risks. Historically evolved, non-integrated EM management systems can make it difficult to identify the trends that reveal the bigger picture, so valuable time may be lost before a contamination issue is fully understood and solved. In the worst case, QC staff are overwhelmed by it all and the safety of patients is put at risk. Recent years have seen a stream of FDA Warning Letters relating to data integrity issues, with the most frequent observation being missing or incomplete records. Consequently, the 2022 PDA Technical Report No. 13 recommends a computer-based data tracking system to be implemented.
The importance of data integrity
In its 2018 industry guidance Data Integrity and Compliance With Drug CGMP, the FDA defines data integrity as referring to “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).” It is important to stress that data integrity regulations apply to any form of data management, whether digital or paper-based. While providers of EM platforms will usually create and communicate ways to meet regulatory requirements with their software, QC labs using self-designed solutions and procedures are on their own when it comes to staying up-to-date on accepted practices and implementing changes.
To offer customers integrated solutions that can manage all their EM data digitally, we have formed cooperations with the EM software providers Novatek International (Montreal, Canada) and Archilex (Montagnola, Switzerland). Communication manuals have been created that explain how to make the software of our partners work together seamlessly with our instruments and consumables—all our products for viable air, surface, and personnel monitoring in cleanrooms and isolators (e.g., MAS-100® microbial samplers, ICR contact plates, settle plates and swabs) allow data transfer or have the necessary barcode to scan sample information into a software database. However, our partnerships are not exclusive. We intend to leave the choice of EM software to customers and keep our portfolio open to operate with any commercial software platform.
The benefits of EM data management solutions
Our cooperation with Novatek has resulted in an interface for bidirectional communication of the fully 21 CFR Part 11 compliant EM Software with our portable MAS-100 NT® microbial air sampler. The instrument exchanges all necessary data with the EM software, offering full data traceability, user access controls, user rights, and time stamps. Sampling protocols can be set up outside the cleanroom and securely uploaded to the sampler. The operator follows the instructions on the EM mobile device and takes the samples as per SOPs. After sampling, the data is sent to the software’s database for storage. Similarly, data transfer can be managed for the MAS-100 Iso line of viable air samplers for use in RABS and isolators if they communicate with compliant EM software or LIMS. The MAS-100 Atmos® microbial compressed gas sampler has its own 21 CFR-compliant software and can transfer all relevant sample data wirelessly using its result barcode.
EM software solutions support a wide range of functions, including the preparation and execution of sampling plans, the tracking of incubation and its results, data compilation and exploration, as well as root-cause analyses based on short or long-term trending. Users can perform real-time searches with filters applied for classes, environments, rooms, staff members, and other relevant data associated with sampling points. This gives a clearer, more comprehensive picture of the situation than by analyzing the data from each EM method separately. Search results can be used to generate trends, statistics, reports, and graphs, for example of the distribution of microbial species or genera. It is worth noting that trending is now mandatory according to the revised EU GMP Annex 1 and requires EM data to be considered before a product batch is released.
Where environmental monitoring is heading
Several trends can be observed in microbiological environmental monitoring. Two examples are that consumables and instrumentation are being designed to minimize the contamination risk during transfer into the manufacturing environment and that greater use is being made of single-use equipment and consumables. The value of this is leveraged by the trend that workflows are being digitalized and automated to minimize the risk of critical human errors and regulatory breaches while speeding up and improving data management to enable real-time assessments and earlier contamination alerts. Implementing a computerized system for all EM data will also put manufacturing facilities in a position to adapt to future requirements easier and faster.
Read how to achieve full data integrity and compliance for the MAS-100 NT® microbial air sampler.
www.SigmaAldrich.com/Data-Integrity
Publication Detail
This article appeared in American Pharmaceutical Review:Vol. 27, No. 1Jan/FebPages: 30-31
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