Here, we define sanitation process validation as "establishing documented evidence that a sanitation process will consistently reduce microorganism populations on inanimate
surfaces to preestablished levels that are considered safe." The preestablished microbial bioburden levels must be based on
public health codes, regulations, industry guidelines, or a scientifically sound rationale.
In the pharmaceutical and food industries, the sanitation process typically follows a cleaning stage. Cleaning with a detergent
usually removes or kills more than 90% of vegetative bacteria present on surfaces. The surviving microorganisms are mostly
surface-attached, and the sanitation process will inactivate them in-situ.
Disinfectant effectiveness tests do not mirror in-service conditions. The test microorganism inoculum used in DETs does not
mimic the behavior of environmental growth (e.g., biofilms and surface-adhered microorganisms). In addition, DETs fail to consider the effects of the preceding cleaning stage.
Therefore, the testing conditions used by agents manufacturers for disinfection and sanitation have little relationship to
the sanitation processes actually used in the pharmaceutical industry. Manufacturers rely on use-dilution and carrier tests
to provide data for registration in the United States and for recommended in-use concentrations.
Validation of a sanitation process should instead be based on empirical measurements of sanitizer effectiveness in working
conditions, suggesting the logical equation:
successful field tests under in-use conditions = validation.
For chemical disinfectant and sanitizing agents already registered under FIFRA in the United States or the CEN TC 216 work
program in the EU, there would be no need to perform in-house effectiveness tests. The DETs already performed by the manufacturer
for registration should be sufficient. Abundant experience and USP draft chapter ‹1072› show that sanitizers and disinfectants are more effective in actual use than the DETs indicate. Furthermore,
the high inoculum counts used in the laboratory studies represent a "worst-case" scenario. We should, therefore, be able
to rely on a second logical equation:
registration = qualification.
This approach would make in-house DETs unnecessary, and would greatly simplify the sanitation validation process by removing
the most difficult step; performing DETs. Only sanitizing or disinfecting agents that have not been registered for the intended
purpose would then require additional qualification with DETs.
Surface tests would still be required to develop procedures for sanitation processes. These tests would assess the effectiveness
of the selected sanitizer against surface-adhered microorganisms. In these assays, microorganisms are dried onto surfaces,
sanitized, and then removed for counting by conventional techniques or rapid microbiological methods (RMMs). Established surface
tests are straightforward and inexpensive, and can thus be carried out by most microbiology laboratories. Surface tests can
reflect in-use conditions like contact times, temperatures, use-dilutions, and surface properties. These tests can be modified
to follow a representative cleaning stage, and so will better mimic real in-use conditions. The proposed sanitation process
would be developed from the surface tests. Finally, the proposed sanitation process would be validated via challenge in field tests.
The sanitation process validation would then be performed following a simple methodology:
- clean the equipment;
- sanitize the equipment;
- take microbial bioburden samples.
The validation of agents for sanitizing and disinfecting seems like a major undertaking, but does not need to be. These agents
are not validated; they are qualified for the intended purpose, and then the sanitation process itself is validated. The
most difficult part in sanitation process validation would be the execution of disinfectant effectiveness tests by the user.
In-house DETs are superfluous, however, when the selected sanitizer or disinfectant has been registered in accordance with
FIFRA or the CEN TC 216 work program. The sanitation process validation methodology proposed here includes cleaning as part
of the sanitation process, and sanitation process validation becomes the successful execution of field tests under actual
in-use conditions. The resulting methodology would be cost-effective, simple, and time-saving.
My gratitude to Daniel Y. C. Fung, professor of food science at Kansas State University, for his kindness in reviewing a draft
of this article. And special thanks to Douglas McCormick, Advanstar Communications, for his assistance in the final editing
of the manuscript.
José E. Martinez is a consultant for JEM Consulting Services Inc., PMB 652 Box 4956; Caguas, PR 00726, tel. 787.349.3857,