Hi Laura,

USP 27 <71>  is partially harmonized. It is efective January 1 2004.
We will attempt to keep our clients informed as to the approval or
non-approval of there various test by our review of upcoming editions of the
Pharmacopeias Forum in the year 2004.

 Harmonized

The following portions of the testing have been harmonized.

  1.. Growth promotion for bacteria is 3 days and 5 days for fungi.
  2.. B & F test is now called the "validation test".
  3.. With approval of different minimal amounts (weight or volume) has been
promulgate per container of sterile liquids insoluble topical, solids and
devices.
  4.. For membrane filtration, do not exceed a washing cycle of
     5 x 200mL.

  5.. All incubation periods are for 14 days.
It is recommended that the following incubation temperatures for soybean
casein digest broth be changed from 20 - 250C to 25-30C



 Non Harmonized

1.      Anything related to devices.

2.      Growth promotion allowed as "periodic" testing of different batch
prepared from the same lot of dehydrated medium.

3.      Use of alternative strains for Staphylococcus aureus, Pseudomas
aluginosa, and Clostridium sporogenes.

4.      Storage media for one month in unsealed containers performing growth
promotion within 2 weeks of use.  Storage for 1 year is acceptable if using
tight containers and growth promotion is performed within 3 months of use.

5.      Rinses fluid A, D and K.



Sincerely,

Daniel Prince, Ph.D.
Gibraltar Laboratories, Inc.
122 Fairfield Road
Fairfield NJ 07004-2401
973-227-6882 x519
www.gibraltarlabsinc.com
----- Original Message -----
From: "Moskie, Laura" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Tuesday, November 18, 2003 6:16 PM
Subject: [PMFLIST] Sterility test harmonization- USP with others?




Hi,

Does anyone have information or references on whether the usp sterility
test has been/ is in the process/etc. of being harmonized with the EU
and the ICH?

Laura Moskie

Medarex
519 Route 173 W
Bloomsbury, NJ  08804

Tele.(732) 479-2608

Fax (732)479-2401






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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com