In the Clinical Research arena, the Environmental Monitoring (EM) Program – comprising of viable and non-viable monitoring elements – is designed to routinely monitor particulates as well as micro-organisms in key spears of pharmaceutical manufacturing facility, especially in the aseptic processing areas. While the viable or micro-biological monitoring is replete with routine monitoring of the manufacturing environment for the trace of micro-organisms, the non-viable particulate monitoring, calculates the airborne particle count and further offers inputs on the routine maintenance of the clean room air classification.
There are many methodologies in use for micro-biological monitoring such as passive air sampling to look for settle plates, active air sampling or air sampler, surface sampling, looking for contact plates and swabs and personal sampling looking for finger plates or plates of gowns.
Purpose of EM
The main aim of the micro-biological EM is to gain inputs on micro-biological quality of the environment, besides to look for possible contamination dangers. If one cares to keenly follow the data analysis and trending, these inputs can be put into good use to assess the microbial flora of the environment and to further set action and alert limits from the available historical data.
Implementation of EM
A well defined and documented sampling plan, along with the associated Standard Operating Procedure (SOP) is involved to the successful implementation of an effective EM program. What is more, the SOP should be reviewed and revised from time to time, if the necessity is felt.
The cardinal aspects to be strictly observed and documented within the EM SOP are sample locations, sampling technique, monitoring frequency, and timing – during operation or at rest, action and alert limits, besides the investigative and corrective actions to be taken, when it overshoots the limits.
When you choose the sampling locations for environmental program, care should be taken to the design of the area and to the process. As per the FDA Guidance for the Industry, Sterile Drug Products Produced by Aseptic Processing – cGMP, Section A.11, you should include in the monitoring program, the monitoring locations that present the highest possible contamination risk to the product.
Furthermore, the monitoring locations should also be opted by observing the complex activities taking place and the flow of personnel in the processing area to come to a conclusion that the most potentially high-risk contamination areas. If the sample locations were randomly selected using the grid approach for non-viable particulates as specified in ISO 14644 series, clean rooms and associated controlled environments until recently, with regards to Clean Room Management in Pharmaceuticals and Healthcare, p4233, this method involves applying a grid over the clean room plans and selecting sample sites at equal distances in each zone. As this method of selection is inherently random, meaning it does not involve identifying locations which pose the greatest microbiological risk to the product.
Risk Assessment Tools
The risk assessment tools that are in vogue to track monitoring locations include Hazard Analysis Critical Control Points (HACCP) and Failure Mode Effect Analysis (FMEA) techniques. HACCP analysis is the identification of critical control points in a process and the determination of methods to prevent and control the occurrence of hazards.
Seven Step Process
According to ICH Q9 and Pharming Reviews No. 1 Current Perspectives on Environmental Monitoring (May 2010), Chapter 96, HACCP analysis typically involves a seven step process: conducting a hazard analysis to track the sources of contamination, assessing Critical Control Points (CCPs), setting up critical levels, establishing systems to monitor CCPs, initiating corrective actions when critical action limit deviations happen, having a record keeping system in place and establishing procedures to verify HACCP system is working efficaciously.
The pre-requisite you should have, while using HACCP analysis to determine the sampling locations in an EM Program is to have an in-depth knowledge of the process ad area. We can do this activity by a having a cross-functional team, which should have personnel from technical services, quality control as well as from the operations sides. Also, you need to list the key sources of contamination associated with the process and area in the hazard analysis stage itelf, with the help of process/work flow diagrams.
Risk Based Approach
Using a risk based approach, when you set up EM Program drives a continual review of trends and a periodic re-assessment of the program, as this will not only contribute in a big way to demonstrating control of the manufacturing environment, but also ensuring that the EM programme adheres to the regulatory requirements and expectations.
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