MICROBIAL QUALITY CONTROL Table V Sterilizing Method for the Filling Equipment 81 Equipment Sterilizing method Storage tank Filling machine Pump Pipes Tools Disinfectant solution (chlorhexidine in 70 per cent alcoholic solution) Disinfectant solution (iodine type) Disinfectant solution (iodine type) Hot water Disinfectant solution (chlorhexidine in 70 per cent alcoholic solution) Figure 6. Working personnel wearing sterile dust-free garments prevent any contamination of the product from this source. Ethylene oxide gas sterilization conditions are the same as those described under cellulose gums. The microbial count found in these tubes is shown in Table IV. The collapsible tubes are received wrapped in a polyethylene protective film and then packaged in corrugated cartons. In this packaged form, the collapsible tubes are sterilized by ethylene oxide gas and subsequently con- veyed in the polyethylene wrapped form through the pass box into the clean room.
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.
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