How can do the environmental monitoring during HVAC validation?

Dear members,

I have finished DQ, IQ and OQ of our new HVAC system which ISO class 8. I have completed all validation activities except microbial monitoring. I would like to set the plan for microbial monitoring. Regarding this i have a following doubts.

  1. How can we select the sampling points?
  2. Which methods to be followed?
  3. How can we set the Alert and action limits?
  4. If action limits exceeded which action is required?
  5. Is there any procedure to select the sampling points for every method i.e.Settle plate, Contact Plate and air sampling method?
  6. Once validation is completed how we can perform the environmental monitoring?
  7. What is the regular frequency of environmental monitoring in class 100000 area?
  8. How many methods to be applied for microbial monitoring?

kindly supply your valuable answers so that we can finish our HVAC validation at earliest.

looking anxiously for your reply.

Thanking you

Pulla Reddy Karnati
09912054829

Class 100000 areas enviromental monitoring is not so stringent as class 7 or lower classes.
You can evaluate once in an year and that by using settle plates to find the counts of fungi and bacteria.
The only thing that lacks in such area is proper cleaning procedure and sanitation programmes.
If you have sound cleaning and sanitation programmes at your facility in this area and if you moniter them well it will be good enough to carry out monitoring the counts once in 1 year time period.
Your aim is to keep the bacterial and fungal counts to loowest possible extent to protect other zones getting contaminated.
In this area you must maintain a minimum of 20 air changes and I would suggest you take always fresh air instead of a recirculatory system.
I like to see comments from other experts regarding this question.

Regards

[quote=Pulla Reddy]Dear members,

I have finished DQ, IQ and OQ of our new HVAC system which ISO class 8. I have completed all validation activities except microbial monitoring. I would like to set the plan for microbial monitoring. Regarding this i have a following doubts.

  1. How can we select the sampling points?
  2. Which methods to be followed?
  3. How can we set the Alert and action limits?
  4. If action limits exceeded which action is required?
  5. Is there any procedure to select the sampling points for every method i.e.Settle plate, Contact Plate and air sampling method?
  6. Once validation is completed how we can perform the environmental monitoring?
  7. What is the regular frequency of environmental monitoring in class 100000 area?
  8. How many methods to be applied for microbial monitoring?

kindly supply your valuable answers so that we can finish our HVAC validation at earliest.

looking anxiously for your reply.

Thanking you

Pulla Reddy Karnati
09912054829[/quote]

Dear Pulla ,
Answer of your Question is as follows,

  1. How can we select the sampling points?
    No. of sampling points for non viable particle count can be calculatedas per formulla √A. A= Room Area in m2.
    Location of sampling points should be decided on the basis of risk assesment of that area.For a new area to be qualified at least 15 Days monitoring is required.

  2. Which methods to be followed?
    Please clear the question.

  3. How can we set the Alert and action limits?
    On the basis of trand data of contineous monitoring Alert and action limits are set.
    Generally Alert limit can be set as mean count of a perticular location+2SD , Where SD= Standerd deviation
    Action limit can be set as mean count of a perticular location+3SD , Where SD= Standerd deviation

This is a generalized method for calculation of action and alert limit. Other stastical methods like percentage Occurance can also be used for that.

  1. If action limits exceeded which action is required?
    If action limit exceeds then a OOT should be filled.It should covered in your CAPA system.A investigation should be done for finding route cause . impact assesment should also be done.

  2. Is there any procedure to select the sampling points for every method i.e.Settle plate, Contact Plate and air sampling method?
    No. of sampling points for non viable particle count can be calculatedas per formulla √A. A= Room Area in m2
    Location of sampling points should be decided on the basis of risk assesment of that area.For a new area to be qualified at least 15 Days monitoring is required.
    For settle plate and active air sampling locations are selected on the basis of risk assesment of area. Location validation can also be performed but I don’t thinkit is required for grade D area.

  3. Once validation is completed how we can perform the environmental monitoring?
    After validation you can reduce no. of sampling points and monitoring frequency on the basis of the criticality of your process and area.

  4. What is the regular frequency of environmental monitoring in class 100000 area?
    Once in 15 days as per USP and FDA regulations.

  5. How many methods to be applied for microbial monitoring?

    1. Settle plates 2. Active air sampling 3. Surface Swabes 4. Contact plates

Please remember that there should be a procedure for Identification of Environmental Isolates. If some suspected organism is detected then it should be identified.

Regards,
Avinash Tomer

Hi,

  1. How can we select the sampling points?
    There is no rule in this regard. Normally in this case worst case should be identified it may be near or at the machine, may be near the return duct. you should go the area and observe the work pattern and find out the worst case.
  2. Which methods to be followed?
    Normally in this area settling plates method is used but u can use the air sampler as well.
  3. How can we set the Alert and action limits?
    first, observe the results of three days monitoring then set the alert and action limits.
  4. If action limits exceeded which action is required?
    When action limit exceeded, start the extensive cleaning program, check the filters at AHUs. Observe the area during operation and find out the reason of microbial count elevation.
  5. Is there any procedure to select the sampling points for every method i.e.Settle plate, Contact Plate and air sampling method?
    In this area, there is no standard procedure. you must find out the worst case.
  6. Once validation is completed how we can perform the environmental monitoring?
    Well, it depends upon your results initially you may check at every 15 days then one month and then 3 months if you are increasing the interval you have to prove with data that your area is working under controlled conditions.
  7. What is the regular frequency of environmental monitoring in class 100000 area?
    not clearly defined but once in a month is a good control.
  8. How many methods to be applied for microbial monitoring?
    setteling plate and air sampling

I hope these answers will fulfill your requirements.

Imzee

How can we select sampling points?
Assuming that your HVAC has recirculation - one of the worst case scenario is to expose plates near the return grills.
The other worst case scenario is the place were you expect maximum movement - which would mean places of entry and exit.
Hope this adds some value.

  1. How can we set the Alert and action limits?
    On the basis of trand data of contineous monitoring Alert and action limits are set.
    Generally Alert limit can be set as mean count of a perticular location+2SD , Where SD= Standerd deviation
    Action limit can be set as mean count of a perticular location+3SD , Where SD= Standerd deviation

Dear Avinash,

I don’t understand this method,Is that means Alert limit= average+2SD?
In that case,my firm’s soften water has a acceptance criteria—0.1~1.0 mg/L,How can we set the Alert and Action limits?

Thank you in advance
yeqiao.zhang@scinopharm.com

Does anybody have an format of the qualification protocols of a ISO class 8 facility please