Isolators have always been an inevitable part of the Pharmaceutical Industry. The motto of the isolator is to make sure that an airtight barrier has been created to have absolute separation in between the product and operator. The operator has to go for performing a task through either glove ports or half-suits. To put in simple words, isolators impart a kind of particular and desired environment inside the isolator using filters.
That specific environment inside the isolator can be either positive or negative. It holds the ability to control humidity, oxygen, and airflow. The earliest uses of these isolators used to be for sterility testing. The aseptic filling isolator is available in various size and configuration. The right one can be chosen according to the requirement. An only trained person is allowed to control the isolator. These isolators are known for creating safe environment according to the type of application.
Major Features Of Isolator –
- Recirculated Unidirectional Airflow
- Temperature Regulation
- Full PLC Control
- Safe Change HEPA Filters
- Air velocity measurements
Pharmaceutical Industry cannot even imagine without the isolators. With the help of isolator, it becomes easy to ensure safety, transfer in and out without affecting containment.
What About The Design Advantages?
It seems important to mention that an isolator is a kind of fully sealed unit which is sanitized using vaporized hydrogen peroxide. The drug substance filled inside the isolator is processed within a closed system having the completely isolated environment. The motto of using aseptic filling isolator is making sure the operator safety. Moreover, this way also minimizes the risk of contamination of drug products. There are many advantages of the design of the isolator –
- It comes up with an oval design which is ergonomically beautiful and considered right to speed up productivity.
- They are made up using the best stainless steel construction so the drug safety would be ensured completely.
- The advance PLC control makes easy to operate. It means operators do not have to confront so many hurdles while using it.
- It holds a special “mouse hole.” Generally, it is protected by unidirectional airflow in order to make sure the exit of filled vials. This is very much required to create that needed isolated environment which helps to process the drug available inside the isolator so it would not be contaminated.
- The new age isolator has been designed putting extra efforts so they can have a great ability of temperature control. It makes easy to have ambient temperature along with high/low set points. Saying would not wrong that temperature controlling feature is everything when it comes about isolators.
The Available Options
- RTP system for sterile liquid entry
- Having a connection at external vial washer on the exit of the isolator
- Air circulatory within windows to take make the procedure easiest
- Clean in place systems is the next on the list making these isolators an inevitable part of the system
- The isolator is also available with the feature of safe change filters
- Full validation services available along with IQ/OQ protocols.
Pharma industry cannot imagine without isolators. They are being used on a large scale for processing drugs to get desired results. The new age isolators are coming up with new features.