MICROBIOLOGICAL SPOILAGE IN PHARMACEUTICALS AND COSMETICS 737 1 would like to correct you if I may--I did not say that we wish to train people in micro- biological techniques: I actually said that I think it creates a considerable impact if you show your manufacturing staff, be they operatives or supervisors, the organisms they carry, and the organisms in the manufacturing environment, and what these organisms can do to the product. For many years my predecessor trained the staff in our sterile product areas and now we are trying to extend this training to people who are manu- facturing non-sterile products. When you show people what they are carrying around it creates such an impact that they become more careful. While we certainly do not want to delegate our quality control function to production, we do want to make production personnel keenly aware of the problems by means of realistic demonstrations, best done by two types of courses. The first one lasts for about 3• days and is for supervisors. They go into the subject in some depth, but perhaps not so much as do the sterile products staff. The other is for operatives, and one might have several hundred to deal with. This can be done by dividing them into small groups and using a carousel slide projector to show pictures, a taped commentary, and attendance by microbiology technicians who can swab participants, take samples, and show actual spoiled products. This takes perhaps 2 h. After a gap of 2 days the people are brought back and are shown the microbes isolated from the swabs.
J. Soc. Cosmet. Chem. 23 739-772 (1972) ¸ 1972 Society of Cosmetic Chernists of Great Britain An appraisal of methods for detecting primary skin irritants A. B. G. LANSDOWN* Synopsis--Problems involved in the safety testing of cosmetic chemicals for SKIN IRRITANCY are discussed with reference to ANIMAL and HUMAN STUDIES. A survey of the literature shows that no single test is adequate to detect all skin irritants to man but that the PATCH TEST PROCEDURE firstly in animals and subsequently in man is the most suitable screening method. Test compounds should be applied to areas of intact and abraded skin under open and occlusive conditions. HISTOLOGICAL EXAMINATION of treated skin is advisable in animal studies to detect changes not visible to the naked eye. TAPE STRIPPING may be useful in human studies where histology is not possible. DYE EXTRAVASATION techniques for tissue injury are insufficiently sensitive. Although some methods for demonstration of the function of skin APPENDAGES were considered, they have not been used sufficiently to establish their value for use in routine studies. Information acquired from patch tests may serve as a basis for conducting secondary tests including biochemical, electrical and mechanical studies IN VIVO or IN VITRO. These tests are not, on available evidence, superior to the patch test and no direct interpretation of the results in terms of tissue damage exists. Tests for materials used in cosmetics should resemble closely the intended 'in-use' applica- tion of the final product and the conditions of test should simulate consumer usage. Definitive tests of this type are followed in practice by pre-marketing trials in which a product is tested as reconm•ended on the label. INTRODUCTION In a safety testing programme for substances intended for inclusion in cosmetic or toilet preparations, it is desirable to employ test conditions that typify the recommended use of the final product as closely as possible (1). * British Industrial Biological Research Association, Woodmansterne Road, Carshalton, Surrey. 739
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