736 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS (22) English, M.P. The fermentation of malt extract by an osmophilic yeast. J. Gen. Microbiol. 9 No. 1 15 (1953). (23) Wills, B. A. Fungal growth in Syrup of Tolu. J. lPharm. Pharmacol. 10 302 (1958). (24) Payne, M. and Smart, R. Unpublished. (25) Kallings, L. O., Ringertz, O., Silverstolpe, L. and Ernerfeldt, F. Microbiological con- tamination of medical preparations. Acta lPharm. Suecica. 3 No. 3 249 (1966). (26) Elliot, R. P. and Michenar, H. D. Microbiological standards and handling codes for chilled and frozen foods. A review. Appl. Microbiol. 9 No. 5 452 (1961). DISCUSSION D•.. H. S. BE^N: We have been talking about the levels of contamination and many people have been talking in terms of not more than 100 micro-organisms g-• product. Connected with this standard there should be a time factor. When must the product meet this requirement? Immediately after manufacture or when somebody has been around the country and bought some off pharmacists' shelves 2 months, 2 years later? My colleagues and I have examined perhaps many thousands of different types of systems in our laboratory and we have found that the count never remains constant for very long. If the product has some antimicrobial action itself the count goes down but it may go up. The product may pass the test today and fail next week, next month, or next year. The third possibility is that the count will initially go down, and then we shall suffer quite considerable subsequent multiplication. If the product is liable to contamination and good manufacturing practice will not, or cannot, keep the number down below the limit we must include a preservative. When we are talking in terms of standards for pharmacopoeias or some other compendia we have to be quite sure about the type of product to which we are applying these standards. If the product is capable of support- ing growth then it is not sufficient to merely state that the product should contain not more than 100 micro-organisms g-• because inevitably sooner or later it will. If the pro- duct is capable of supporting growth then we have to state some measure of the activity of the product against the invading micro-organisms. DR. J. R. GWILT: YOU referred to the need to train production people in micro- biological techniques and a participant from Italy also referred, en passant, to the need to check production people, at least to ensure that the products were not contaminated where they had infections. One thing that concerns me very much is that there seems to be more stress upon the environment and particularly upon the raw materials, than upon the people concerned. It seems that there are two ways in which the people who are in production, hospitals, and so on are involved. The first one I would call a negative way-- the people who are the shedders and the carriers in production some of these we can pick up through high plate counts in the area when they are actually working with, for instance, sterile products, or we can find some of the carriers by throat and nose swabs. The second instance is where the people are positive, i.e. they definitely contribute. There is a tendency, certainly in the U.S.A., to dub quality controllers as second class, and bacteriologists, I fear, sometimes as third class. They are the people who should be involved in plant hygiene and also consulted where there are any changes in process, procedure or in packaging because all these can have such an enormous influence upon the survival, and the persistence, of bacteria in the products. DR. SPOONER: I agree and would like to applaud you when you say that people are important because I think that obviously they are the major factor in manufacturing.

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.