Use of Pencil in Class 1000 Cleanroom

[somashekar]

A simple question ...
Is use of pencil (and of course the pencil erasor) be considered a good manufacturing practice within a class 1000 cleanroom ?

 

[Wes Bucey]

Re: Use of pencil in cleanroom

A simple question ...
Is use of pencil (and of course the pencil erasor) be considered a good manufacturing practice within a class 1000 cleanroom ?

I would think a pencil (not too soft a lead) might be OK, but the eraser generates too much dust and debris (rubber, paper, and graphite) - what do workers currently use and why?

 

[somashekar]

Re: Use of pencil in cleanroom

I would think a pencil (not too soft a lead) might be OK, but the eraser generates too much dust and debris (rubber, paper, and graphite) - what do workers currently use and why?

For the very reason that you stated, I am not for use of pencil. But I seek to know from people some GMP followed in cleanroom operations regarding this. Workers have just carried the normal room working habit into the clean room as far as writing goes.

 

[SteveK]

Re: Use of pencil in cleanroom

A simple question ...
Is use of pencil (and of course the pencil erasor) be considered a good manufacturing practice within a class 1000 cleanroom ?

When I worked in the pharmaceutical industry (GMP/FDA regulated), if you used anything other than a black pen on any documentation you would be taken outside and shot! OK I exaggerate, but use of pencils, Tipex, Post-it notes etc, especially in the manufacturing (clean) area, was seen as a capital offence.

Steve

 

[MIREGMGR]

Re: Use of pencil in cleanroom

Is use of pencil (and of course the pencil erasor) be considered a good manufacturing practice within a class 1000 cleanroom ?

As SteveK questions above...what record is being kept, for which erasure (as opposed to line-out and annotation of the change) is an acceptable recordkeeping process?

I agree with Wes's particulate/general contamination concern as well.

 

[raghu_1968]

Re: Use of pencil in cleanroom

A simple question ...
Is use of pencil (and of course the pencil erasor) be considered a good manufacturing practice within a class 1000 cleanroom ?

As per the Good Documentation Practice (followed in pharma industry), the usage of pencil is not permitted.

The usage of eraser (and Pencil) is also not permitted, not only in the clean room but also in the other GMP areas (Processing areas other that the clean room).

 

[Wes Bucey]

Re: Use of pencil in cleanroom

I want to point out clean rooms are not just for the pharma industry.

I was not addressing the record-keeping, which, of course, requires non-erasable notes in many industries. Most address the note-taking with the use of computers to avoid poor legibility of notes and to maintain a record, via password requirement, of who made the note and when (the "when" often being important, especially if something is later found to be amiss.) Paper is a poor medium for clean rooms of super classes simply because at bottom it is just a "paste" of wood chips or rag bits which can and does dissolve even in dry environment as the binder deteriorates and the paper dries and crumbles.

 

[Denis]

Re: Use of pencil in cleanroom

Depending on the industry - mine is a pharma supplier , and we manufacture in high classification clean rooms, the use of anything wooden is not allowed.

Wood , cardboard and paper are seen as carriers of contamination and therefore not allowed.

Records being altered by use of an eraser is also poor cGMP practice, as this is seen as falsification of records.

I would say its a bad idea and shouldn't be allowed - but it will depend on your manufacturing environment etc

 

[e006823]

Most of my clean-room experience has been in ASIC fabrication and assembly (class 100 and class 1000). Use of a pencil in a clean room is ill advised, even in a class 1000 clean room. It is much better (from a cleanliness stand point) to use ball point pens (minimal particulate and out gassing) The particles from the graphite in the pencil can get on gloves, clean room garments etc. and subsequently transferred to product.

 

[jkuil]

Can anyone tell me where I can find the pencil shapener?