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Data Integrity issues Data integrity issue can be found in very simple processes where management is not focusing.  Take example of cleaning and sanitisation process. Most of the organisations records cleaning and sanitisation in the morning so as to start production activities. If Quality unit watch this activity carefully, it can identify lot of data integrity issues. 1. Most of the records are documented with almost same time and period.  I.e if shift starts at 9:00 hrs, you may find cleaning and sanitisation is documented at 8:00 to 8:30 hrs. The duration of cleaning activity in one room will always be similar.  I.e 30 to 40 minutes. 2. If the firm is using floor cleaning machine, you will never find any breakdown.  Neither you may find spare machine. 3. Generally cleaning is performed by contracted workmen and hence it is likely that record may be documented by officers.  This can create lot doubt whether the person is moving along ...

Steam Quality Testing Steam Quality, Purity and quantity can be affected by the design , use and Maintenance of overall steam system. Steam Systems should be designed to ensure that the steam delivered to the sterilizer is saturated steamhaving a steam quality of 97% to 100 %. Steam of poor quality can contribute to wet packs and sub-optimal steam sterilization cycle that might not be identified by bilolgical monitoring. Steam Provides moistire that allows the coagulation of cell wall proteins and supplies the energy that heats the components and maintains their temperature, the combinationof moisture and temperature results in sterilization. The higher the temperature, the shorter the sterilization time required. For proper sterilization, steam requires a number of attributes.  For these reasons, steam quality testing should be applied to steam sterilizers Steam Quality testing is the phrase sometime associated with a series of three physical tests (non condensable ...