Environment monitoring validation


(Chetan Hirpara) #1

how to do environment monitoring validation of clean room area ?
and how to prepare validation protocol of EM ?


(Manoj Singh) #2

Select the most worst location for contamination.
1.Near entry exit door
2.near return riser
3.at work station where more activity is performed.


(Manoj Singh) #3

Use inclined petri plate stand below return riser .
Use parallel petri plate stand under LAF at working height.


(Manoj Singh) #4

location of sampling should be shown in protocol.you should also include environmental monitoring procedure ,alert and action limit.


(Chetan Hirpara) #5

Thank you very much…
How can we define the action and alert limit…
And does it change in yearly basis?


(Manoj Singh) #6

Action limit mentioned in EUGMP guideline and USFDA guideline


(Manoj Singh) #7

For alert limit validate the area and fix it.


(Chetan Hirpara) #8

how we define alert limit ?
any formula is for alert limit .
please guide me on this topic…


(Gecicek) #9

Alert limit is defined by historical data of trends, if you don’t have any historical data, calculate the alert limit less than %10-%20 of action limit until you get the trends of the area


(Carlos E. Alanís) #10

Im looking for references in wich includes or describes how to estimates the sampling points in a clean room; i´ve heard a few years ago, there is a guide for this matter. If you have any comment or guide, i´ll appreciate. Thanks


(Dhanaraju Rengasamy) #11

we are also waiting the same question ? bro

Pls. can any one answer ?

Thank you.


(Amol Kale) #12

PDA TR13 describes much about how to select sampling locations.
However risk assessment or justification for selected locations of sampling locations is required.


(Lokesh) #13

Dear sir,

Is there any formula to calculate the number of locations in a room for viable monitoring.

please suggest me


(Albert Groeneveld) #15

There are two methods:

  1. Active Air Monitoring
    Assessing microbial quality of air should involve the use of active devices including but not limited to impaction, centrifugal, and membrane (or gelatin) samplers. Each device has certain advantages and disadvantages, although all allow testing of the number of organisms per volume of air sampled. We recommend that such devices be used during each production shift to evaluate aseptic processing areas at carefully chosen locations. Manufacturers should be aware of a device’s air monitoring capabilities, and the air sampler should be evaluated for its suitability for use in an aseptic environment based on collection efficiency, cleanability, ability to be sterilized, and disruption of unidirectional airflow.20 Because devices vary, the user should assess the overall suitability of a monitoring device before it is placed into service. Manufacturers should ensure that such devices are calibrated and used according to appropriate procedures
  2. Passive Air Monitoring (Settling Plates)
    Another method is the use of passive air samplers, such as settling plates (petri dishes containing nutrient growth medium exposed to the environment). Because only microorganisms that settle onto the agar surface are detected, settling plates can be used as qualitative, or semi-quantitative, air monitors. Their value in critical areas will be enhanced by ensuring that plates are positioned in locations posing the greatest risk of product contamination. As part of methods validation, the quality control laboratory should evaluate what media exposure conditions optimize recovery of low levels of environmental isolates. Exposure conditions should preclude desiccation (e.g., caused by lengthy sampling periods and/or high airflows), which inhibits recovery of microorganisms. The data generated by passive air sampling can be useful when considered in combination with results from other types of air samples.

Refer to ISO 14698 Annex C4 for specific guidelines.