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FDA Inspection Issues.
July 18, 2013

Steam Quality dictates its ability to sanitize consistently.

If you use steam in any way i.e CIP/SIP, sanitation, sterilization including autoclaving an other cleaning activities, then it is essential that the quality of your steam is known, and regularly monitored to ensure it is consistently within the prescribed values.  Any planned or unplanned changes to the system that could result in the system integrity being changed or compromised must result in the steam quality being re-verified.
It is a simple and comparatively cheap process to verify the steam quality; it can be an utter calamitous event to fail to verify compliance.
Do not run this risk, go ahead and purchase our interactive steam quality testing kit that will arrive complete with pitot and expansion tubes and fully detailed interactive protocols.  So simple any lab technician can complete all the tests within three hours.
Quality Steam Validation Kit. -- $499.00

HEPA Filer Compliance Issues.

High Integrity air filters have recently figured in a several very targeted warning letters.  It is very important to remember they are not Fit and Forget items; you must establish the filter dirty pressure-drop (change filter) indication. (i.e filter clean pressure-drop + filter range = filter change pressure).
To reiterate; the filter manufacturers clean pressure drop value is always given at a specific flow rate.  When the actual flow in your system is lower than this flow;  your filter clean pressure drop will also be low and when it is high your filter clean pressure drop will also be high.  You must therefore measure the flow and calculate what your pressures are to enable you to declare what the filter dirty change pressures is. Regulators expect to be able to review your documented methodology for this important task.
We have a very simply easy to use test script used for this purpose.  Why not purchase it and paste it into all you SOP's and protocols that deal with HEPA filter testing.

HEPA Filter Clean PD Correction - $26.00.

No matter whether you use our templates or completed protocols using our IQ, OQ and PQ documents along with their interrelated plans and assessment documents produces the thorough audit trail needed to meet all internal or external regulatory reviews or inspections.

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