J. Soc. Cosmet. Chem. 23 415-426 (1972) ¸ 1972 Society of Cosmetic Chemists of Great Britain The clinical significance of the presence of micro-organisms in pharmaceutical and cosmetic preparations M. T. PARKER* Presented on 29th September 1971 in London, at the Symposium on 'Microbial control', organized by the Pharmaceutical Society of Great Britain and the Society of Cosmetic Chemists of Great Britain. Synopsis--Contaminated PHARMACEUTICAL preparations may cause DISEASE when injected into tissue, implanted into wounds or normally sterile areas of the body such as the bladder or the lower respiratory tract, or, in certain circumstances, when deposited on the skin or administered orally. Of the organisms found in pharmaceutical preparations, only the salmonellae cause disease when administered to healthy persons by a 'natural' route. The rest are 'conditional' pathogens, which cause disease in healthy persons other than newborn infants only when injected into the tissues or implanted directly into a sterile area of the body but in certain classes of susceptible persons it is sufficient to deposit the organism on the skin or to administer it orally. These classes include patients with severe pre-existing disease, patients with lowered resistance due to therapy, and infants during the first few days of life. Most of the ORGANISMS of clinical significance in pharmaceutical preparations aro 'free-living' types of GRAM-NEGATIVE BACILLI, and belong to the klebsiella, enterobacter, serratia, pseudomonas and flavobacterium groups. They have simple nutritive characters and can multiply at ambient temperature in fluids apparently devoid of organic matter. Many of them have a remarkable ability to survive and even to multiply in the presence of commonly used DISINFECTANT and BACTERIOSTATIC agents. *Cross-Infection Reference Laboratory, Central Public Health Laboratory, London, NW9 5HT. 415

416 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS INTRODUCTION Almost everything that we know about the ill effects on patients of receiving pharmaceutical preparations that are contaminated with micro- organisms has been learned from hospital practice, and without doubt it is in hospitals that most of the trouble is seen. This is not surprising, because patients often come to hospital with pre-exisfing diseases that make them particularly susceptible to infection, and in hospital many of them are necessarily subjected to procedures--diagnostic, surgical and pharma- cological-that further increase this susceptibility and some of these procedures expose the patient to specific hazards from contaminated preparations. The chance that such a complication would be recognized and attributed to the contaminated product is greater in hospital than outside but even in hospitals an isolated infection from a medicament is relatively difficult to detect, and the fact that a number of patients in the same hospital often have received the same preparation greatly increases the chance of recognizing ill effects due to it. Therefore, although there is little information about illness attributable to contaminated medicines in general practice, we should be wrong to assume that it does not occur. Even less is known about the significance for the user of microbially contaminated cosmetic preparations. Cosmetics are applied mainly to the normal skin of healthy persons, and there is little reason to believe that the common microbial contaminants would cause disease in these circum- stances. If used by members of the general community who have a pre- existing skin disease, the ill effects if any would be very difficult to attribute to the preparation. Certain cosmetic preparations--notably hand creams and lotions--find their way into hospitals, and their microbial state then becomes a matter for serious concern. CO•qSEQUENCaS OF ^DMINISTm•NO CO•qT^MIN^TED MEDIC^MENTS BY V^RIOUS ROUTES Whether infection occurs, and the form it takes, depends very much on the route of administration, the dose of organisms, and the class of person to whom the contaminated preparation is administered. Injection Organisms may be implanted directly into the tissue by injection. Unless there is pre-existing disease of the heart valves, or a foreign body in the circulatory system, the intravenous injection of small numbers of most organisms is without ill effect. Serious consequences therefore mainly