Hygiene testing is an important and regulated part of the hygiene regimen in food and pharmaceutical processing facilities. A typical application is to determine whether a cleaned surface meets the relevant standard for cleanliness with respect to organic material. Several closely related methods are used for hygiene testing. The most common is adenosine triphosphate (ATP) hygiene testing. ATP is an important molecule in living systems as it is used to transport and exchange energy within living cells. Thus, the presence of ATP implies the presence of cells. Other hygiene testers use proteins or sugars as target molecules.

Regardless of the particular molecule, the principle and application of hygiene testing is similar. Samples can either be liquid samples or swabs wiped across the test surface. The samples are mixed with appropriate reagents (often packaged within a swab for greater ease of use) and then a reading is taken. Generally, hygiene testing makes use of luminescence so that the presence of the target molecule is announced by the release of light. The swab or sample is placed in a luminometer, which is often a simple handheld unit programmed to provide pass or fail results to the user.

It is important to recognize that these methods are not very specific. A “positive” hygiene test simply notes the presence of organic or cellular material in the sample, but provides no identification of the sample. For hygiene and cleanliness, this is often sufficient. It does not matter whether the contaminant is food residue or the bacteria that causes botulism. However, hygiene tests are often coupled with complementary testing using cell culturing and life science instrumentation that can provide a more definite identification, offering better information for the purposes of mitigation. Hygiene testing’s main advantage is that results are provided in a matter of seconds, rather than hours or days taken by traditional cell methods.

The simple nature of these tools makes them well suited for use in food processing facilities, which makes up the vast majority of this market. They are also used to some extent in pharmaceutical facilities, but such facilities typically rely more heavily on advanced techniques.

Although laboratory benchtop luminometers are used for this application, handheld luminometers are far more common, since they can be more readily carried to the test site by the user. These systems cost only a few thousand dollars and have enough battery power to carry out hundreds of tests on a single charge. The treated swabs and other consumables needed for the tests cost on the order of $1 per test. The total market for hygiene testing in 2008 was approximately $50 million.

The leaders in this market are UK-based Biotrace International, which was acquired by 3M in late 2006 (see IBO 10/15/06), Hygiena and the Biochemicals Products division of Kikkoman, a Japanese company known as a world leader in soy sauce and other food products.

Hygiene Testing at a Glance:

Leading Suppliers

• Biotrace (3M)

• Hygiena

• Kikkoman

Largest Markets

• Food and Beverage

• Pharmaceutical

• Biotechnology

Instrument Cost

• $1,000–$5,000