Building and maintaining the standards of the modular sterilized unit can be challenging. It is a place where your products will be manufactured and tested and therefore it is also a place of crucial importance that needs strict practices and control methods in order to build and maintain it. If you do not do so the relevant authorities will be able to penalize you for not doing the same. With all these rules and regulations in place, it can definitely begin to feel like the protocols are not assisting but hindering business. However, here are some of the biggest mistakes that you need to avoid when building or maintaining sterilized units so that your business can actually benefit from all the laws.
Not Keeping Your Sterilized Unit Clean and Neat
Any builders of clean rooms Australia will tell you that a sterilized unit is only allowed to have a very minute amount of dust and contaminants. These should not interfere with the safety of the product being manufactured inside the unit. However if you keep on manufacturing without any cleaning, these contaminants will build up to levels that are not safe anymore. Always maintain a neat and clean unit so that contaminants do not multiply.
Not Recording Everything
The FDA and other authorities continue to report violations that happen in sterilized units all the time and much of these are only because there is not enough recording to back anything up. You must, therefore, never make the mistake of recording some processes and not others. On the other hand, you should always record everything so that if the need arises you can use these recordings.
Not Using Ink and Resorting To Pencils
Some people might think that recording in pencil is a good idea because it gives you the chance to go back and make changes to the records if needed later on. However you must only use blue or black ink and never a pencil for the recording purposes. If changes are noted in the records, you will be held responsible and accountable for these and the best way to avoid such complications is to maintain complete transparency and record in pen as clearly as possible. Also remember that if you do not need any records you have the right to destroy them immediately. But also make sure that you keep the records with you for the given amount of time before you destroy anything at all.
Not Cleaning the Filters Regularly
You may think that you do not need to clean up the filters in the unit until they are visibly clogged and dirty. However nothing could be worse than this. Always make sure that the sterilized unit is clean and well maintained at all times. If there is insufficient or incorrect airflow in the unit there will be issues and things like viral growth can occur. This will easily contaminate the product that you are creating. You will also need to constantly monitor the bio burden so that you are able to maintain control of the integrity of the product.