environment and also be sterilized. Only the small quantity of the final product should be tested to confirm therapeutic and sterility value(Fisher et al. , 2018). The rest of the final product should only be indicated how they were processes and be confirmed it is safe for human use. Examples of containers that are used for interferon alpha products include the vials, ampules for sterile water and syringes.
Validation Asssignment_2018 12 The process of vials filling includes checking the vial weight, filling the desired product volume, inserting the vials stoppers and over sealing to secure the stoppers. All vials must undergo a process of inspection including both manual or automatic inspections(Chen, Chen and Wang, 2014). This might be done in the filling process where rejected vials are discarded. The ISO 5 environments are where the most aseptic processing should take place. This is due to the fact that, this environment where product and other parts are exposed. The other classes of the standard are used in other environments depending on the potential impact the process will bring to the final product. During the filling process, dirty personnel and waste must be separated from clean operators and the products. This requires separate airlocks and corridors for clean and dirty activities(Abramowitz, 2016). Due to the presence of many dirty operators, it is recommended to use isolators during the filling process. Monitoring of the cleanrooms According to WHO, there are four major tests that are used in monitoring the microorganisms in a cleanroom which include settle plates, volumetric testing, finger labs, and contact plates(World Health Organization, 2011). However, not all test are done for every activity of monitoring a cleanroom. For class A, finger labs, settle plates, and volumetric testing must be done for every operation(WHO, 2016b). Depending on the plant, several samples can be taken for a test for every monitoring shift. The environmental monitoring should be performed according to the risks observed by the producer. Selection of a sample site must be considered when monitoring. Sample sites should be don inside the cleanroom where most individuals come into contact with the product(Conner et al. , 2014). All clean rooms should be analyzed through the use of a risk assessment before the testing samples are taken(Zhang, Sun and Ma, 2017). Highly used areas should be monitored frequently as compared to low-risk areas. The risk-benefit relationship should be used to govern
Validation Asssignment_2018 13 procedures and equipment monitoring accessibility high-risk zones(Abramowitz, 2016). The sample should be taken in a way that reduces more risks in high risks areas other than bringing sampling devices than increase contamination. Where monitoring is considered unacceptable, the proof must be provided with proper documentation.
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- Winter '16
- Bill Oyieke
- Semiconductor device fabrication, contamination control, Cleanroom