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RE: Water requirement for glassware washing

Kimberly
 
For laboratory glassware the cleaning requirements are based on Good
Science. After cleaning there should be no residual substances - previous
reagents, cleaning agents, water residues, etc. that can interfere with
subsequent analyses. Many companies use Purified Water USP or Ph Eur as the
final rinse, but equally many companies use water from commercially
available laboratory water purification systems.
Regarding Validation of the glassware washer, knowing that the washer will
always (or as close to always as is practical) produce clean glassware
should save you a lot of time and effort in checking the cleanliness after
each run. 
 
Alan
 
Alan Newbery
Senior Compliance Consultant
KMI, a division of PAREXEL International LLC
Tel & Fax +44 (0)1437 741745
email: anewbery@belmont.kminc.com <mailto:anewbery@belmont.kminc.com>
 
 

-----Original Message-----
From: gmp@www2.pharmweb.net [mailto:gmp@www2.pharmweb.net]On Behalf Of
Kimberly (by way of John Dolman<moderator@the-dolman-consultancy.com>)
Sent: 23 August 2002 10:12
To: GMP Forum
Subject: Water requirement for glassware washing


We are a pharmaceutical compnay with a QC laboratory that is trying to
validate the glasswarewasher.  My first question is:  Does the Glassware
washer of laboratory glassware need to be validated?  The second question is
what type of water doe sthe final rinse of the glassware cycle have to be?
I have heard varying opinions from qualified individuals, some say USP, some
say DI?
What requirements does DI water have to meet?  Is pH one of those
requirements or is restivity, conductivity & total dissoled solids a valid
criteria?  Please help.  Is there any FDA guidelines on this?

--------------------------------------------

Kimberly
kaa@discocow.com
DDT Technologies

--------------------------------------------



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