How do you define a containment strategy?
FPS Food and Pharma Systems srl
World leading manufacturer of custom isolators for ADC, HPAPI and Sterile.
First of all why do you need a containment strategy? Because it will drive the design of the facility and the type of process equipment you choose but mostly because it is the containment strategy that will dictate the conditions for operators to handle potent products safely. ?
?Now how do you define your containment strategy? You start with the characteristics of the products to be handled: we are talking about the occupational exposure limits (OEL) that will clearly indicate how potent they are. Then you must factor in the quantities involved and how fluffy the powders are. The second factor is the duration of the process and the frequency.
You put all these factors in a matrix and it will tell you what you need. At the low end of the spectrum you will find the least potent products, handled infrequently, in small quantities. For those a simple personal protective equipment will do.
As you move up in the matrix you will find downflow booths, RABS (those are Restricted Access Barrier Systems). And on the high end of the spectrum you will have rigid isolators.
?And what about if you have some process equipment that was not designed for containment? Actually this process equipment can be fully or partly integrated in isolators. A close cooperation between the equipment manufacturer of the process equipment and the isolator manufacturer can lead to excellent containment performances.
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And how to you test the performance of your containment strategy?
Once the systems are installed, you can perform SMEPAC tests. They will simulate the entire process using a placebo compound. Specific sensors are installed in the room to measure the airborne concentration of the compound. The sensors are placed close to the breathing area of the operator and on the sensitive areas of the containment systems. They measure the total exposure of the operator and verify that it is below the maximum exposure limits of the APIs.
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