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Microbial Contamination / Cleanliness

USP 61 – United States Pharmacopoeia – The National Formulary, USP XXIII, 1995, General Chapter 61

Test Parameters and Requirements

Microbial Contamination / Cleanliness of materials under concern is assessed with the parameters and requirements listed below:

Test Parameter	Requirements

(A) Total Aerobic Plate Count	Refer to CTFA* Guidelines
(B) Total Combined Molds & Yeasts Count	Refer to CTFA* Guidelines
Total Viable Count (A) + (B)	< 5000 cfu/ml
E. coli	Absence
Staphylococcus aureus	Absence
Salmonella species	Absence
Pseudomonas aeruginosa	Absence

cfu = colony forming unit

*The U.S. Personal Care Products Council is formerly the CTFA (Cosmetic, Toiletry and Fragrance Association)

Cosmetics / Liquids / Pastes / Gels / Powders used in Toys

With regard to toys, Clause 4.3.6.3 of ASTM F963-07 refers to USP 61 for the cleanliness of cosmetics / liquids / pastes / gels / powders used in toys

Details of the organisms

Escherichia coli (E.coli) is a bacterium that is commonly found in the lower intestine of warm-blooded animals. Most E. coli strains are harmless, but some, such as serotype O157:H7, can cause serious food poisoning in humans, and are occasionally responsible for costly product recalls. The harmless strains are part of the normal flora of the gut, and can benefit their hosts by producing vitamin K₂, or by preventing the establishment of pathogenic bacteria within the intestine.^[4][5]

E. coli are not always confined to the intestine, and their ability to survive for brief periods outside the body makes them an ideal indicator organism to test environmental samples for fecal contamination. The bacteria can also be grown easily and its genetics are comparatively simple and easily-manipulated, making it one of the best-studied prokaryotic model organisms, and an important species in biotechnology. E. coli was discovered by German pediatrician and bacteriologist Theodor Escherich in 1885, and is now classified as part of the Enterobacteriaceae family of gamma-proteobacteria.

Staphylococcus aureus literally "Golden Cluster Seed" and also known as golden staph, is the most common cause of staph infections. It is a spherical bacterium, frequently living on the skin or in the nose of a person. Approximately 20–30% of the general population are "staph carriers". Staphylococcus aureus can cause a range of illnesses from minor skin infections, such as pimples, impetigo (may also be caused by Streptococcus pyogenes), boils, cellulitis folliculitis, furuncles, carbuncles, scalded skin syndrome and abscesses, to life-threatening diseases, such as pneumonia, meningitis, osteomyelitis endocarditis, Toxic shock syndrome (TSS), and septicemia. Its incidence is from skin, soft tissue, respiratory, bone, joint, endovascular to wound infections. It is still one of the four most common causes of nosocomial infections, often causing postsurgical wound infections. Abbreviated to S. aureus or Staph aureus in medical literature, S. aureus should not be confused with the similarly named (and also medically relevant) species of the genus Streptococcus. It is often found in the nostrils of the human body.

S. aureus was discovered in Aberdeen, Scotland in 1880 by the surgeon Sir Alexander Ogston in pus from surgical abscesses. Each year some 500,000 patients in American hospitals contract a staphylococcal infection.

Salmonella is a genus of rod-shaped Gram-negative enterobacteria that causes typhoid fever, paratyphoid fever, and foodborne illness. Salmonella species are motile and produce hydrogen sulfide. Salmonella antibodies were first found in Malawi children in research published in 2008. The Malawian researchers have identified an antibody that protects children against bacterial infections of the blood caused by Salmonella. A study of 352 children at Blantyre's Queen Elizabeth hospital found that children up to two years old develop antibodies that aid in killing the bacteria. The researchers, quoted in the Science and Development Network, say this could lead to a possible Salmonella vaccine.

Pseudomonas aeruginosa is a Gram-negative, aerobic, rod-shaped bacterium with unipolar motility. An opportunistic human pathogen, P. aeruginosa is also an opportunistic pathogen of plants. P. aeruginosa is the type species of the genus Pseudomonas (Migula 1894).

P. aeruginosa secretes a variety of pigments, including pyocyanin (blue-green), fluorescein (yellow-green and fluorescent, now also known as pyoverdin), and pyorubin (red-brown). King, Ward, and Raney developed Pseudomonas Agar P (aka King A media) for enhancing pyocyanin and pyorubin production and Pseudomonas Agar F (aka King B media) for enhancing fluorescein production.

P. aeruginosa is often preliminarily identified by its pearlescent appearance and grape-like odor in vitro. Definitive clinical identification of P. aeruginosa often includes identifying the production of both pyocyanin and fluorescein as well as its ability to grow at 42°C. P. aeruginosa is capable of growth in diesel and jet fuel, where it is known as a hydrocarbon-utilizing microorganism (or "HUM bug"), causing microbial corrosion. It creates dark gellish mats sometimes improperly called "algae" because of their appearance.

Although classified as an aerobic organism, P. aeruginosa is considered by many as a facultative anaerobe as it is well adapted to proliferate in conditions of partial or total oxygen depletion. This organism can achieve anaerobic growth with nitrate as a terminal electron acceptor, and in its absence it is also able to ferment arginine by substrate-level phosphorylation. Adaptation to microaerobic or anaerobic environments is essential for certain lifestyles of P. aeruginosa, like during lung infection in cystic fibrosis patients where thick layers of alginate surrounding bacterial mucoid cells can limit the diffusion of oxygen.