High Potency Drug Manufacturing Containment Systems

Source: Dec Group

At Extract Technology we believe there are five questions you need to ask yourself before purchasing a high potency containment or isolator system. Creating a safe environment for people working with highly potent substances is not an easy task. It’s not just a matter of buying a readily made solution.

It has to be operated and maintained properly to ensure the people working with the hazardous materials will not be exposed. Institutions have to invest a fair amount of money in their containment systems – that’s why, if you’re considering purchasing one, these five questions below will help you specify your containment needs before contacting a containment system vendor.

A high potency drug manufacturing isolator is an enclosure that contains a qualified controlled environment, sealed to a high standard of leak tightness. Used when products are so potent that a downflow booth couldn’t provide enough protection, Isolators contain the product inside while the operator works with it by placing their arms through glove ports.

When deciding in favor of an pharmaceutical Isolator, a factor to consider is cleaning. The pharmaceutical Isolator has to be totally neutralized before it’s opened to maintain equipment kept inside. No powder residue can be left as this could cause cross contamination to the next batch.

Pharmaceutical Isolators are equipped with safe change HEPA filters and fans operating at slightly negative pressure as well as pressure sensors and gauges that monitor the system. If a glove is breached, the fan speeds up to maintain the desired air flow and negative pressure to protect the operator. Users should perform leak testing on a regular basis, following procedures and protocols. A glove testing device might have to be procured alongside the Isolator to ensure safety.

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