I need to validate an existing cleanroom facility that will be upgraded,
Somebody can told me if I will need to write a Valdation master plan for the validation activities that will be need to be done for the facility and it HVAC system ? renew an BOD etc...
Thanks in advance for the advice:confused:

Hi, and welcome to the Cove :bigwave:

Could you tell us a bit about what the upgrade of the cleanroom consists of? That may make it easier for people to provide input.

Agree with Gert Sorensen. You may provide some infomation in more details.

Does the existing facility already have a validation plan? If so, that will be your best start.

Also, do you have a copy of the ISO specification for Clean Rooms? You will probably need that also.

I need to validate an existing cleanroom facility that will be upgraded,
Somebody can told me if I will need to write a Valdation master plan for the validation activities that will be need to be done for the facility and it HVAC system ? renew an BOD etc...
Thanks in advance for the advice:confused:

Welcome to the Cove :)

The steps required to qualify the Clean Room will be as follows -

URS (User requirements specifications)

· Design qualification DQ

· All the data for the DQ

o Then qualify utilities and appropriate equipment

o Then qualify the facility itself

o Then qualify the clean room as per ISO 14644 requirements

I would begin by constructing a flow diagram.
One flow diagram to understand the actual processes within the clean rooms.

A seperate flow diagram for the engineering layout of the service system.

This approach would highlight the critical areas to validate.

You could perform an FMEA on the areas and attach some form of risk assessment to begin to tackle the project as a whole.

The FMEA could form the backbone of your VMP.

Can you involve the contractor who is providing the upgrade, using the URS against the agreed specification in terms of air changes and resultant microbial activity.

The DQ and IQ should be the realm of the contractor . You should be focusing on the OQ and PQ, with SOP's to maintain the validate state.

Thanks you for answer me so quickly,
I was out the office for few days, so I could check the forum sooner.
Answer to Gert Serensen:
the upgrade is quite simple the room was originally built on 1999, as same standart of cleanroom, but was define as protected environment class 300000.
No qualification or other validation was done only testing against specification when we receive the commissioning of the room.
The room is wide open space , with lot of half size partitions to delimited different area. The room was design and build as cleanroom class 100000 ISO8
with HEPA fitered ceiling.
no the facility have no validation plan.
The room now will be remodulated to accomodate the new production and the room will be classified as ISO 8.
My question is more oriented about the VMP if normal to do a seperate VMP only for the facility, HVAC and the supported utilities ( electricity, com, gas, AC, etc...) ?
The process will be validated as seperate VMP, this is a seperate issue.
So Denis the process Flowdiagram is not my issue. What is the FMEA?
Thanks all to helping me
Best regards
ERIC:agree1::agree1:

FMEA stands for Failure Mode Effects Analysis , search the forum for information on this tool.

I have used FMEA within validation to some success in determining the risk , and tackling issues in a structured manner.

Gert's the validation expert, so anything I say will be superceded by him.

Your title says validation master plan, I would think you would want to encompass in the master plan the different processess that need to be validated as part of producing product/services.

You may want to stagger your validations, so all your requalifications don't come up at once.

The upgrade is quite simple the room was originally built on 1999, as same standart of cleanroom, but was define as protected environment class 300000.
No qualification or other validation was done only testing against specification when we receive the commissioning of the room.
Okay, then what kind of monitoring of the clean room have you performed in the past?

The room is wide open space, with lot of half size partitions to delimited different area. The room was design and build as cleanroom class 100000 ISO8 with HEPA fitered ceiling.
Do you mean that it has been rebuilt to be class 100000 or that it was originally built to be class 100000?

My question is more oriented about the VMP if normal to do a seperate VMP only for the facility, HVAC and the supported utilities ( electricity, com, gas, AC, etc...) ?
The Validation Master Plan is - as the name indicates - a Master plan :) This usually means that it encompasses all the validation activities that are to be performed. The VMP is used to prioritize validation activities and allocate ressources to the validation tasks. Once this is done you create validation protocols for the individual validations. This should be done as a team, it is not supposed to be the task of a "lone ranger".... Remember that your validation criteria needs to be clear and established before you start the actual validation. For clean rooms you should definitely keep in mind that, the worst case conditions include amongst many others: After long term breaks in production (ie. after weekend shut downs), just around changes in shifts (day/evening/nights/weekendproduction), etc. You also should consider the way the HVAC system interconnects with the rest of the facility, etc. etc. etc. See why it is a group task??

The process will be validated as seperate VMP, this is a seperate issue.
Yup, completely seperate.

I have been a bit preoccupied lately, so forgive my manners :)

First of all, thanks to Qualityalways and Denis for the very good and useful information. :thanks:

Second, thanks to BradM for the kind words and for having so much faith in me. It may exceed the reality of my abilities, but it is still appreciated. :thanx:

First of all, thanks to Qualityalways and Denis for the very good and useful information. :thanks:

My pleasure Gert. Let us help each other