8-2 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Figure 7. Container structure Table VI Results of Metal Tube Sterilization by Ethylene Oxide Gas Microorganisms Check Result Before sterilization After sterilization q-• : 4 tubes n equals 45 tubes { --•: 41 tubes q-' : 0 tubes n equals 45 tubes { --•: 45 tubes "Contamination. "Noncontaminated. Check of Microorganisms at Pilot Production Scale During Processing As shown in Fig. 8, a special study has been conducted to determine the means to prevent microbial contamination in raw and packaging materials during processing and filling procedures. The results, as can be observed from the pilot production scale, indicate that there are no signs of contamination whatsoever in the various samples at the different sites of the process.
Oil part S-1 Water part MICROBIAL QUALITY CONTROL 83 (70 øC, 20 min) -- (Emulsification)-- (Deaeration) •-- 5-2 Sampling points Result S-1 (--) S-2 (--) s-3 (-) s-4 (-) (-) s-6 (-) S-7 (--) S-3 (70øC, 20 min) S-4 (Cooling) (Storage) (Filling) Figure 8. Testing of final product for microbial contamination Table VII Sampling Time and Sampling Unit in the Course of Actual Production Sampling Time Sampling Unit Untilled product hnmediately after manufacturing Each batch One week after manufacturing Each batch Finished prodnet Immediately after filling Half-day One week after filling Half-day Microbially Free Assurance In order to assure a microbially free product in actual production, samples were taken during the pilot production scale. These were studied as shoxvn in Table VII. Filling is carried out after confirmation that the untilled product passes all tests. Shipment (as a finished product) is done only after it is determined that the product meets all other rigid standards set for it. The tests performed to confirm the number of microorganisms and their species in untilled products and finished products are shown in Fig. 9. RESULTS IN ACTUAL PRODUCTION Check Results of Products Based upon the experimental results obtained, we standardized the micro- bially free techniques in the various stages of manufacturing process and
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