欧盟GMP-3.pdfVIP

63. Chemical or biological indicators may also be used, but should not take the place of physical measurements. 64. Sufficient time must be allowed for the whole of the load to reach the required temperature before measurement of the sterilising time-period is commenced. This time must be determined for each type of load to be processed. 65. After the high temperature phase of a heat sterilisation cycle, precautions should be taken against contamination of a sterilised load during cooling. Any cooling fluid or gas in contact with the product should be sterilised unless it can be shown that any leaking container would not be approved for use. Moist heat 66. Both temperature and pressure should be used to monitor the process. Control instrumentation should normally be independent of monitoring instrumentation and recording charts. Where automated control and monitoring systems are used for these applications they should be validated to ensure that critical process requirements are met. System and cycle faults should be registered by the system and observed by the operator. The reading of the independent temperature indicator should be routinely checked against the chart recorder during the sterilisation period. For sterilisers fitted with a drain at the bottom of the chamber, it may also be necessary to record the temperature at this position, throughout the sterilisation period. There should be frequent leak tests on the chamber when a vacuum phase is part of the cycle. 67. The items to be sterilised, other than products in sealed containers, should be wrapped in a material which allows removal of air and penetration of steam but which prevents recontamination after sterilisation. All parts