whether the microbes are viable or not during transport. In addition, the manufacturer should assess the risk involve when transporting the microbes to the laboratory from the processing unit. Settle plates are usually used to monitor the bacteria descending from the air over a plate. Although, the detection of settle plates depends on the type of microbe and their settling rates, settle plates can be assumed as the only method that can be used for continuous monitoring of microorganism in the cleanroom(WHO, 2016b). The high-risk zones of contamination are considered places to place the settle plates. Settle plates should be placed in the process room but caution should be taken to avoid obstruction of the process or
Validation Asssignment_2018 15 contamination of them(World Health Organization, 2011). The measurements from settle plates should only be taken when the levels of activities are high or duration of the operation period. If the settle plates start drying, the new ones should be put into place to allow the maximum time is taken(WHO, 2016b). Validation data should always determine individual settle plates but not as a group. The manufacturer should set time to make sure the required data is obtained with certain shifts. The process areas and other adjacent areas should be monitored using the above methods in a given period of time. If the company is not working for a certain period no monitoring should be put into place. Below is a table that demonstrates the recommended frequencies for monitoring in different grades. Table 3: different frequencies for monitoring in various grades Classification Volumetric(2) Settle plate(2) Contact plate Glove print Grade A (filling operations) Once per shif Once per shif Once per shif Once per shif Grade B Daily Daily Daily Daily Grade C Weekly Weekly Weekly N/A Grade D Monthly Monthly N/A N/A UDAF in B Once per shif Once per shif Once per shif Once per shif UDAF in C Weekly Weekly Weekly Weekly UDAF in D Monthly Monthly Monthly N/A (World Health Organization, 2011) Conclusion Most drugs that are genetically engineered are produced through the use of biotechnology. Interferon alpha is among the biotech drug where the most commonly produced drug is interferon alpha 2-b. Considering many pharmaceutical and biotech drugs are produced under a well-controlled cleanroom, interferon alpha drug is not an exception. A cleanroom is considered a placement with highly controlled measures where various
Validation Asssignment_2018 16 biotechnological and medicinal products are manufactured. For a cleanroom to be fully functional various international standards have to be taken into action. According to ISO 14644, the concentration of airborne particles in a controlled room is specified to certain standard limits depending on the product manufactured. A cleanroom can have various contaminations which include personals, equipment used, nature of production and from the facility itself. Classification of cleanrooms depends on the standards set international although some countries have their own standards. The commonly used standards include the
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- Winter '16
- Bill Oyieke
- Semiconductor device fabrication, contamination control, Cleanroom