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October 1999


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Anthony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Fri, 29 Oct 1999 12:22:25 -0400
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                     WASHINGTON DRUG LETTER * SEPT. 6, 1999 Vol. 31, 
     Drug firms' bioburden monitoring programs must encompass often-overlooked items such as incoming components from suppliers.  For example, firms should conduct baseline bioburden tests on equipment parts such as stoppers, bioburden monitoring on such vendor-supplied parts is often neglected, but is just as critical.
     FDA inspectors stress that bioburden testing is necessary even if a firm autoclaves the incoming stoppers using an overkill cycle and/or performs heat molding to prevent pyrogen growth.  The only way firms can get an idea of the incoming microbial load on the stoppers is to conduct a bioburden run, the agency said.
     Inspectors recommend that such tests include both bioburden evaluation and the collection of baseline data.  In a related issue, automated stopper processors * used to wash and siliconize stoppers * must be routinely validated, demonstrating endotoxin reduction.  Any reduction failure must be investigated according to written procedures.

Is this routine or periodic monitoring after collection of baseline data?

Many companies validate their autoclave cycle by directly inoculating BIs on to rubber stoppers. Periodic monitoring of incoming stoppers show a very low bioburden and stoppers are washed, dried and siliconized again using a validated process.

If there was an inherent problem with moist heat-resistance spores persisting on stoppers we may expect to see media fill failures for aseptically-filled products.

Tony Cundell

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