AUSTAR's Advanced Approach to Sterile and HPAPI Isolation

Last year, AUSTAR won a special international project with specific requirements. The Occupational Exposure Limit (OEL) for the active pharmaceutical ingredient (API) is as low as 1.5 micrograms/ m3 (or at OEB level 4). Additionally, as an injectable product, its production environment must be sterile. In the pharmaceutical industry, both sterile and HPAPI operations can be conducted within isolators, yet there are indeed differences between these two types of equipment.

Sterile isolators are custom-made to protect the product inside, so the core design concept is to prevent foreign materials from entering the equipment. A positive pressure within the isolator chamber is an excellent way to protect the internal environment and product from contamination. This design ensures that the product continuously receives air filtered through HEPA.

On the other hand, HPAPI isolators need to protect operators standing outside the isolator panel. Therefore, a negative pressure design is the key concept, ensuring no product leaks into the operating room.

When handling sterile HPAPI products, it is necessary to reconcile the two conflicting concepts. AUSTAR's engineers decided to use a positive pressure isolator equipped with both plate HEPA filter for laminar airflow and PUSH-PUSH cartridge HEPA filters for exhaust air filtration. The positive pressure isolator complies with GMP concept, and based on historical data obtained from SMEPAC tests in the isolator, the equipment shows excellent performance under positive pressure. With two BIBO HEPA replacement devices, operators can wear regular clean clothes instead of personal protective equipment (PPE) during all stages of operation (weighing, cleaning, maintenance, etc.).