Cleanroom Actions in case of Actions Limit Alarm

ifserav

Involved In Discussions
#1
Hi to all
We are implementing a continouos monitoring system in our cleanroom, and we want to have a document with actions to perform in case the system get alert and action alarms, do you know if any regulation ask for this kind of actions?, what kind of actions do you recommend?

Regards

Sergio Avila
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
Sergio,

ISO 14644-2:2015, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, provides you guidance on setting up a monitoring system

Specifically, section 4.3.6 tells you

Identification and justification of monitoring acceptance criteria or limits, including establishment of a single alarm level, or a dual alarm approach of alert and action levels. The minimum requirement is that a single alarm action level is established. Additionally, an alarm alert level can be established to provide early warning of performance deviation. For further guidance on setting alert and action levels, see informative Annex B.
and the kind of action in sections 3.3 and 3.4, respectively

action level: level of a parameter set by the user which, when exceeded, requires immediate intervention, including investigation of cause, and corrective action

alert level: level of a parameter set by the user giving early warning of a drift from normal conditions, which, when exceeded, should result in increased attention or corrective action
HTH,

Gerhard
 
#4
Hello,
I need help with understanding some of the basic criteria's for clean room and EMPQ. We have a GMP areas that is not going to be certified to ISO 8, but we have in place the internal controls (internal EM program with sampling and monitoring) that mimic all limits and requirements for ISO 8. In this case do we have to perform EMPQ if area is not officially certified to ISO 8? Thank you for your help.
 
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