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What are the specific pathogens that are tested on each pharmaceutical dosage type and why?

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  • What are the specific pathogens that are tested on each pharmaceutical dosage type and why?

What are the specific pathogens that are tested on each pharmaceutical dosage type and why?

The significance of microorganisms in non-sterile pharmaceutical products should be evaluated in terms of the use of the product, the nature of the product, and the potential hazard to the user. The presence of certain microorganisms in non-sterile preparations may have the potential to reduce or even inactivate the therapeutic activity of the product, which has a potential to adversely affect the health of the patient.

The microorganisms tested for depend on the use of the product as hazards vary with the route of administration, the nature of the starting materials and the manufacturing process. Also the nature of the product itself (does it have immunosuppressants or corticosteroids) and the ability to support growth or use of preservatives. The method of application of the product and the demographics and status of the patient (e.g infants, debilitated, disease, wounds or organ damage).

Based on the above assessment the Ph. Eur has provided a table of acceptance criteria for microbiological quality of non-sterile dosage forms (Ref Ph. Eur. 5.1.4.).

Route of Administration

Specified Micro-organism

Non-aqueous preparation for oral use

Absence of E. coli in 1g or 1ml

Aqueous preparation for oral use

Absence of E. coli in 1g or 1ml

Rectal use


Oromucosal use

Gingival use

Cutaneous use

Nasal use

Auricular use

Absence of S. aureus in 1g or 1ml

Absence of P. aeruginosa in 1g or 1ml

Vaginal use

Absence of S. aureus in 1g or 1ml

Absence of P. aeruginosa in 1g or 1ml

Absence of C. albicans in 1g or 1ml

Transdermal patches

Absence of S. aureus in 1 patch

Absence of P. aeruginosa in 1 patch

Inhalation use (special requirements apply to liquid preparations for nebulisation)

Absence of S. aureus in 1g or 1ml

Absence of P. aeruginosa in 1g or 1ml

Absence of bile-tolerant-gram-negative bacteria in 1g or 1ml

Special Ph. Eur provision for oral dosage forms containing raw materials of natural (animal, vegetal or mineral) origin for which antimicrobial pre-treatment is not feasible and for which the competent authority accepts TAMC of the raw material exceeding 103 CFU/g or CFU/ml

Not more than 102 CFU of bile-tolerant-gram-negative bacteria in 1g or 1ml

Absence of Salmonella in 10g or 10mls

Absence of E. coli in 1g or 1ml

Absence of S. aureus in 1g or 1ml


All of the above organisms are indicators of potential contamination. Their presence indicates the potential to cause infection.

Most E. coli strains are harmless and commonly found in the lower intestine of warm blooded organisms, but some serotypes are pathogenic and can cause serious infections.

S.aureus is a member of the normal flora of the body, frequently found in the nose, respiratory tract on the skin and the lower reproductive track of women. Although S. aureus is not always pathogenic it is a common cause of skin infections. Pathogenic strains often promote infections by producing virulence factors such as potent protein toxins that bind and inactivate antibodies.

P.aeruginosa is found in soil, water, skin flora and most man-made environments around the world. It can cause disease in plants and animals including humans. It is a multi-drug resistant organism, recognized for its ubiquity, its intrinsically advanced antibiotic resistance mechanisms, and its association with serious illnesses. The organism is considered opportunistic insofar as serious infection often occurs during existing diseases or conditions – most notably cystic fibrosis and traumatic burns. It is also found generally in the immunocompromised but can infect the immunocompetent as in hot tub folliculitis.

C.albicans is an opportunistic pathogenic yeast that is a common member of the human gut flora. It does not proliferate outside the human body. It is detected in the gastrointestinal tract and mouth in 40-60% of healthy adults. It is usually a commensal organism but can become pathogenic in immunocompromised individuals under a variety of conditions.

Bile-tolerant-gram-negative bacteria belong to the gut flora, gut microbiota or gastrointestinal microbiota, which is the complex community of microorganisms that live in the digestive tracts of humans and other animals, including insects. Their presence indicates potential contamination of animal origin.

Salmonella is a genus of gram-negative bacteria of the family Enterobacteriaceae. Salmonella species are intracellular pathogens and certain serotypes cause illness. When Salmonella invades the bloodstream, it will spread throughout the body, invade organs, and secretes endotoxins causing septicaemia.

The common factor or vector of contamination is of human, animal or environmental origin in testing for the above organisms. Knowing where the organisms live will give an indication of possible sources of contamination. To further identify a possible source identification of species and genus of the organism that is found will be required.

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As part of our provision of the service we conform to current Good Manufacturing Practices (cGMP). We have a proven track record of working in partnership with Pharmaceutical companies providing support services that are not core to their business, releasing people and management time to add value to the pharmaceutical drug development process.


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