For Grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly, except where justified by contaminants in the process that would damage the particle counter or present a hazard, for example, live organisms and radiological hazards. In such cases monitoring during routine equipment set-up operations should be undertaken before exposure to the risk.
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Monitoring during simulated operations should also be performed. The Grade A zone should be monitored at a frequency and sample size such that all interventions, transient events and any system deterioration would be captured and alarms triggered if alert limits are exceeded. It is accepted that it may not always be possible to demonstrate low levels of ≥ 5.0 μm particles at the point of fill when filling is in progress, due to the generation of particles or droplets from the product itself.
Airborne particle monitoring systems may consist of independent particle counters; a network of sequentially accessed sampling points connected by manifold to a single particle counter; or multiple small particle counters located near monitoring points and networked to a data acquisition system. Combinations of systems can also be used. The system selected should be appropriate for the particle size considered.
Where remote sampling systems are used, the length of tubing and the radii of any bends in the tubing should be considered in the context of particle losses in the tubing. The selection of the monitoring system should take account of any risk presented by the materials used in the manufacturing operation, for example, those involving live organisms or radiopharmaceuticals.
The sizes of samples taken for monitoring purposes using automated systems will usually be a function of the sampling rate of the system used.
With regards to the monitoring of 5.0 μm, the limit of 20 is selected due to the limitations of monitoring equipment. It should be noted that alert limits should also be set based on historical and qualification data, such that frequent sustained recoveries below the action limit should also trigger an investigation.
For grade A zones, particle monitoring should be undertaken for the full duration of critical processing, including equipment assembly. The grade A zone should be monitored continuously and with a suitable sample size (at least 28 litres (a cubic foot) per minute) so that all interventions, transient events and any system deterioration would be captured and alarms triggered if alert limits are exceeded.
The occasional indication of macro particle counts, especially ≧ 5.0 μm, may be 1708 considered false counts due to electronic noise, stray light, coincidence, etc. However, consecutive or regular counting of low levels may be indicative of a possible contamination event and should be investigated. Such events may indicate early failure of the room air supply filtration (HVAC) system, filling equipment failure, or may also be diagnostic of poor practices during machine set-up and routine operation. Monitoring conditions such as frequency, sampling volume or duration, alert and action limits and corrective action including investigation should be established in each manufacturing area based on risk assessment.
Definition :
Alert Level – An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow up to address the potential problem. Alert levels are always lower than action levels and are established based on historical and qualification trend data and periodically reviewed.
Action Level – An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.
Isokinetic sampling head – A sampling head designed to disturb the air as little as possible so that the same particles go into the nozzle as would have passed the area of the nozzle had it not been there.
Unidirectional flow – An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed, to reproducibly sweep particles away from the critical processing or testing area
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