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| Solid Dosage Training, Inc. FREE TECHNICAL HELP Compression |
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The Overload Set Point, Told You So!
If you have been following Solid Dosage Training, you know that we emphasize the correct settings for the
overload set point, no matter what type of tablet press you have. Well, now the US FDA is also following
this setting and now considers the “compressing force” and overload settings as critical operating
parameters for a tablet press. Read the 483 citation below. Good luck!
• “After compressing Prenatal Rx1 Tablets lot # 954S9 in May of 2008, compression tooling was found
damaged with chips and broken keys.
• The cause was attributed to exceeding the allowable compression force of the tooling.
• The tooling is rated for_ of compression force and the press was set at _.
• The compression force is a critical parameter but is not recorded in batch records.
• The master and batch production records have not been revised to specify the tooling rating and to
require documenting the compression force.”
– 483 issued to KV Pharmaceutical, Westport, 2/02/09
