FDA Hardening of Autoclave Testing Procedures

Several recent FDA warning letters have included what appears to be a hardening of requirements in autoclave validation.  I deliberately use the term ‘hardening’, because these requirements have been know about; but usually considered as desirable rather than essential.  As such, minimal effort has been exerted into ensuring they were clear and concise.  The warning letters gave loud and clear warning that these two subjects must be included in your temperature mapping of autoclaves.

1)      A documented rationale must be included justifying the number and position of the temperature censors to be used.

2)      A drawing showing their location and identity must be produced and appended to the temperature mapping documentation.

This initially will give many companies problems, however all autoclaves go through exhaustive testing by the original manufacturer at their manufacturing plant.  This testing is normally included in the FAT (Factory Acceptance Testing).  Along with this your initial IQ (Installation Qualification) is intended to show that your installation has not adultered the equilibrium of the design heat flow requirements that were confirmed in the execution of the FAT.  Therefore I would suggest that you contact the relevant people and obtain the documented verification for these two parameters.    

The Importance of Correct Procurement.

When an analysis of the end user's priorities, in procurement priorities, is made the importance of the equipment / programs being validateable ranks at number two out of ten.  Second only to delivery; with cost ranking around sixth. This has been true in over 80% of all cases we have been involved with.

For the-would-be purchaser, it gives enormous reassurance to know that regulatory compliant validation protocols and plans are supplied.  They are often willing to pay a 15 to 30 percent surcharge for these documents.  If a consultant is hired to produce the full suite of validation documents (8/9 documents) considerable costs are involved.  However it is the question; is the system / program actually capable of being validated?  That makes people hesitate.  I doubt (after over twenty years as an auditor) if there is any pharmaceutical company that has not at some time had to abandon new programs or equipment for these reasons.

The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.

Your comments about you having to validate the equipment or program are completely erroneous.  The end user has that task; your task is to ensure that your product is validatable.  That means in all ways it must be compliant with the applicable directives in cGMP.  On our site we carry further details of all these requirements.

Some of Our Current Fast Moving Documents.