Non Viable Particle Monitoring in Aseptic Processing Area

In pharmaceuticals, non viable particle monitoring is as important as viable particle monitoring. In non viable particle monitoring particles of 0.5 µm and 5.0 µm are measured. Particle counter is used for particle monitoring in aseptic area. Basically 0.5-5.0 µm particle range are main source of product contamination because this range of particles carry microorganisms with them. These particles are not settled down easily so these are the main threat to product contamination. If particle contamination increased from the defined limits in the aseptic area then number of particles could also increases in the product as well and could contaminate the products. Different classes has different particle limits defined by EU GMP guideline. So control over these particles is very important to maintain the aseptic area. On the basis of both viable and non viable particles, area is classified. In aseptic area, different factors are responsible for increase of particle contamination. Manufacturing area, equipments, utilities and personnels are main source of particle contamination in aseptic area. For example particles are generated through the movement in aseptic area so movement of the personnels should be controlled and rhythmic in aseptic area.Good manufacturing practises should be followed to control the particle contamination in aseptic area. As per EU GMP 1m³ air should be sampled per location for particle monitoring. Particle contamination depends upon the activity in aseptic area. If there is no activity in aseptic area then particle contamination would be low and if activity is in progress in aseptic area then particle contamination would be increased. That's why guidelines has defined different limits for at rest and in operation conditions. In pharmaceuticals, online and continuous monitoring of particles are also performed in which particle counter gives results in form of print out during production hours. This is very important tool to have great control over the aseptic area during production hours. During monitoring any deviation from the specified limits could results in investigation. Below is the chart showing maximum number of permitted particles in different classes of area as per EU GMP guideline.

Maximum permitted number of particles per m3 equal to or greater than the tabulated size
Grade	At Rest		In operation
	0.5 µm	5.0 µm	0.5 µm	5.0 µm
A	3520	20	3520	20
B	3520	29	352000	2900
C	352000	2900	3520000	29000
D	3520000	29000	Not defined	Not defined

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