Digitalization of Environmental Monitoring as a fundamental aspect of the Contamination Control Strategy

Environmental monitoring (EM) is an essential part of ensuring the microbiological quality of sterile drugs and other sensitive pharmaceutical products. Integrating this approach into contamination control strategies also makes it possible to keep the conditions of cleanrooms and other controlled environments securely within the acceptable limits, which can minimize risks for patients and ensure regulatory compliance.

European Union regulations have significantly strengthened the applicable environmental monitoring requirements, especially with publication of the new Annex 1 of the EU Guidelines on Good Manufacturing Practice (EU GMP). That document states that all facilities must implement a comprehensive contamination control strategy (CCS), including risk assessments and environmental monitoring measures adapted to each process and environment.

In the context of advanced therapy medicinal products, such as those used for cell and gene therapies, sterility takes on even greater importance because these products are administered directly to the patient. In this case, EM is not just a requirement, but also an essential tool for patient safety.

Many companies are still using manual record-keeping systems, which are either entirely paper-based or else hybrid systems that combine computerized tools with manual processes that have not been integrated into them. Although historically these methods have functioned fairly well, they also present some significant risks:

• Human error: omissions, incorrect transcriptions, erased labeling, or unrecorded plates.
• Lack of traceability: difficulty tracking movement among personnel, equipment, and zones.
• Loss of data integrity: lack of change control and risks related to data manipulation or loss.
• Delays in analysis: information takes time to consolidate, which can slow down decision-making.

Aspects like these can have a negative impact on operational efficiency, and they can also result in non‑compliances during regulatory inspections.

Digitalization of the EM process represents a paradigm shift. Implementing validated and computerized systems allows a radical change in the workflow:

• Automation of data collection, using unique barcodes and a barcode reader and automatic recording.
• Full traceability, by automatically and securely linking all elements of the process: personnel, equipment, locations, lots, and environmental conditions.
• Real-time analysis and immediate generation of trends.
• Remote availability of data, which facilitates auditing, corrective actions, and evidence-based decision-making.
• Compliance with CFR 21 Part 11, Annex 11 and ALCOA+ principles, which ensures data integrity, accessibility, and traceability.

In addition, digitalization can reduce operating costs by up to 60%, by optimizing the use of human resources and materials.

In addition to their general operational advantages, digital environmental monitoring systems allow implementation of specific functionalities that directly reflect the requirements from Annex 1. Many of those requirements cannot be adequately implemented or verified when using manual or hybrid processes, and this gives digital systems a real competitive advantage over traditional models.

• Sampling plan with validated control: Configuration of maximum exposure times for settle plates, overexposure alerts, and traceability for each action performed.
• Precise laboratory management: Monitoring of incubation time, with alarms to ensure that incubation complies with the specifications.
• Alerts and limits based on historical data: Automatic calculation of alert and action limits, based on actual statistical analysis (which is key for compliance with Annex 1).
• Advanced trend analysis: Anticipation of risks via automatic detection of deviations, consecutive excursions, progressive increases in counts, and changes in microbiota.
• Predefined reports for lot release: Generation of non-editable reports that include results, alerts, actions, deviations, equipment and materials used, media lots, and discarded samples.
• Audit trail and full traceability: Unalterable records with electronic signature, user name, and date and time (essential for traceability and auditing).
• Validation under GAMP 5: Each software version must be validated for use in GMP environments.

These functionalities reduce errors and operating times, and they also strengthen an organization’s ability to anticipate deviations, pass audits, and release lots more quickly and with greater confidence.

In a context where regulatory requirements are intensifying, and with increasing pressure to minimize risks and optimize costs, continuing to use manual systems represents an operational and regulatory risk.

The evolution towards digitalized environmental monitoring has become an essential requirement for safe and secure operations in the pharmaceutical industry. In other words, this adaptation is no longer an option, but a necessity.

This transformation must be supported by a well-defined change strategy that includes specialized technical support and adequate training for the human team, to ensure an effective and sustainable transition that will have a real impact on the organization’s culture of quality.

Are you ready to make the move to digital?