Why Semiannual Performance Testing Saves Life Sciences Manufacturers Millions in Hidden Risk

History

Bulk Chemical Manufacturer who supplies contract ingredients to a variety of large Pharmaceutical Manufacturers performs many separate processes and production operations within multiple buildings spread over a large campus compound. Question was posed by their Accounting Department regarding cost associated with multiple visits per year versus one annual comprehensive site testing mobilization.

Scope

With over a dozen or more separate buildings containing a variety of Cleanrooms, Fumehoods, Flowhoods and Biological Safety Cabinets this facility has a lot of moving parts as it relates to controlled environmental testing.

At the end of each period’s re-certification all PEC’s and Cleanrooms are performing per specification. Without fail, upon return for the next service period at least a half dozen issues are found and ultimately corrected. Given the current six (6) month increment for re-testing, a problem could pop up shortly after completion of any given survey which would mean that issue could be present for six (6) months if not detected by facilities or production personnel.

We’ve found belts that have broken where air-handlers are no longer providing clean air to certain enclosures or where filters are so clogged with production powders that return air in the space is non-existent and is just causing turbulence within the cleanroom.

These types of issues typically go unnoticed by production personnel and require physical testing to detect. They all have a common theme causing “out-of-spec” conditions in critical manufacturing environments.

Conclusions

Over the twenty-five years of service reports associated with this particular Client, data demonstrates that due to the large number of Primary Engineering Controls (PEC’s) and Cleanroom installations at this facility, problems can occur in-between service visits unbeknownst to Facility Personnel that have the potential to affect product quality.

When a manufacturing environmental issue is identified and product as been produced within that controlled environment it causes a chain of administrative events for the Quality Control Department. Time between the last certification and a discovery of an out of spec condition only compounds the QA process and can sometimes cause products to be put on “Hold”, recalled or destroyed out of an abundance of caution.

The importance of regular testing cannot be understated. These facilities are in constant production mode, and mechanical or electrical issues are bound to happen. Being able to “detect and correct” is vital and cannot be understated in terms of dollars & cents on an Accountants’ spreadsheet.