Environmental monitoring (EM) data provides assurance that medicines made in an aseptic facility are safe for patients and that supply is not interrupted due to contamination issues. An EM program is a vital part of the quality system in modern drug production facilities and is scrutinized by regulatory agencies.

Designing an EM program is a relatively complex task, but is hampered by inadequate guidance and, while there are many different tools available, there is no consensus on best practice for a risk assessment.

This means it is left to each facility and regulatory agency inspector to determine the risk factors for microbiologic contamination and the adequacy of monitoring. Until now.

Justifying your EM program

BioPhorum’s new paper, Environmental Monitoring: A harmonized risk-based approach to selecting monitoring points and defining monitoring plans, will help companies explain and justify their EM programs and assess the highest risk locations with the most probable microbial recoveries.

Following the approach will also help sustain best practice over time. As it is an industry standard, it will reduce the need for individual judgment, ensure minimum sampling requirements for all higher-risk locations and enable the adoption of best practices across the sector. As facilities modernize, the standard also provides a framework for developing EM programs in line with technological improvements.

The guidance comprises a methodology that addresses the four key questions for the design of an environmental monitoring performance qualification (EMPQ) program and subsequent routine EM program:

1. What are the risk factors to consider?
2. How to systematically assess a room with these risk factors?
3. How to define risk levels?
4. What are the minimum standards for monitoring for different risk levels?

“The new BioPhorum EMPQ risk assessment has helped us improve our EM sample site selection based on risk and a documented rationale, resulting in just the right amount of sampling at the right locations,” said Christian Pruckner, Senior Sterility Assurance Specialist, with Hilary Chan, Principal QC Scientist, at Takeda. “This improves compliance and fosters resource management. The risk-based approach also provides consistency both within our company and across the industry.”

The guidance covers grade A-D rooms, including conventional aseptic filling lines, restricted access barrier systems, isolators, background rooms and support rooms. The risk assessment tool systematically evaluates locations within the facility/filling line against standard environmental control elements to determine which areas have the most potential for re-contamination of isolators or contamination risk of rooms during routine manufacturing processes. The six factors identified are:

1. Amenability of equipment and surfaces to cleaning and sanitization
2. Personnel presence and flow
3. Material flow
4. Proximity of open product or product contact material
5. The need for interventions/operations by personnel and their complexity
6. The frequency of interventions (only applicable for grade A).

The standard describes how to use these six factors to systematically assess all areas of a room and ranks them according to the probability of contamination. A set of principles and minimum standards are then proposed to determine where to locate sampling points and select sampling methods to match risk levels.

This second edition of the EM guidance includes revisions in response to feedback on version one and incorporates a series of case studies, which adds significant value for all stakeholders when adopting this global standard.

There is also some exciting news in that the BioPhorum document is beginning to be recognized in more formal guidance. The PDA technical report TR13 Fundamentals of an Environmental Monitoring Program now includes a reference to our guidance and a mention in US Pharmacopeia’s USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments will be added soon.

This international recognition demonstrates the value of BioPhorum’s approach and how it fills a gap in a crucial part of the quality system.

Environmental Monitoring (EM): A harmonized risk-based approach to selecting monitoring points and defining monitoring plans

7.87 MB 2 file(s)
Release Date - 10th November 2020

  Annex 1     environmental monitoring     environmental monitoring in drug product (EMinDP)  

Abstract

The purpose of an EM risk assessment (RA) is to provide information to determine how to distribute monitoring to best verify that processes are operating under control. This step-by step guidance covers the EM RA process and provides recommendations on monitoring sites and methods based on the relative probability of contamination industry guidance addresses these needs and attempts to capture best practices in a useable ‘toolkit’ format. The guide incorporates good practices from biopharmaceutical manufacturers and adheres to current regulatory guidelines.