Sunday, 25 December 2016

Difference between Viable particle and Non-Viable particle

  • Before going manufacturing of pharmaceutical product verify the environment by monitoring method.
  • Pharmaceutical Environmental monitoring of controlled area is performed by two methods.

  1. Viable monitoring or Viable particle monitoring
  2. Non-Viable particle monitoring.

Viable Monitoring or Viable Particle Monitoring:

·         Capable of working successfully.
·         Living microorganism.
·       Able to germinate.
  •   Capable of surviving or living successfully.
  • A viable particle is a particle that contains one or more living microorganisms. These can affect the sterility of the pharmaceutical product and generally range from ~0.2µm to ~30µm in size.
  • Viable particles includes bacteria, Fungi.
  • Different types of monitoring method used for viable particle detecting, such like.
1.    Passive Air Sampling (settle plate method)
2.    Active Air Sampling (Volumetric Air Sampling)
3.    Surface monitoring  (swab sampling or Contact method)
4.    Personnel monitoring (Contact method)

Viable particles are not free floating they need a carrier to float from one area to another area.
  • Non-viable particles main source for movement of the viable particles.
  • Viable particles (Bacteria and fungi) 0.5um to 5.0 um size. So this range of particles are main source of product contamination.
  • Less than 0.5 um is critical of attachment of viable particle.
  • Greater than 5.0 um is large size of particle can not move easily and settle down.

Non-Viable Particles Monitoring :

·         Does not contain living organism.
·         Non-feasible (particle)
·         Unable to survive independently.
·         Manufacturing area, equipment, utilities and personnel are main source of particle contamination in aseptic area.
·         Check the particles of 0.5 um to 5.0 size
·         Electronic particle counter is used for particle counting.
·         This instrument can’t differentiate between viable and non-viable particles.
·         Any particle detected by the sensor of this instrument it will count this particles.

·    For example particles are generated through the movement in aseptic area so movement of the personnel should be controlled and rhythmic in aseptic area.Good manufacturing practices should be followed to control the particle contamination in aseptic area.

·         As per EU GMP 1 m³ 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.

·         So, to control classified area we need to control both viable and non-viable particles.

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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