To protect operators, the production and handling of HPAPI or dangerous products (in gas or powder form) necessitate complete product isolation from the environment. Within the isolator’s closed volume, a negative pressure regime is maintained. Turbulent flow is commonly used.
Containment concerns are becoming increasingly significant in the manufacturing of solid dosage forms.
More than half of all novel chemical entities (NCEs) are classed as powerful (OEL 10 µg/m3), indicating that active pharmaceutical ingredients (APIs) are becoming increasingly effective.
The activity starts with the complete closed-loop system; dispensing & weighing, granules are formed, the bulk is dried, the product is sent for milling and sifting, and blending, then to the tablet compression and blister packing.
Operator access to isolator inside via glove ports or half-suit configuration. Containment levels from 10µg/m3 to 0,01µg/m3 are available, with different manufacturing solutions and configurations.
Milling is a procedure that can produce fine dust particles; this is a problem that needs to be thoroughly studied and investigated in order to maintain correct levels of containment, ergonomy, and process accuracy.
As a result, deciding whether or not to combine a mill with an isolator is a critical technical decision.
Even if the process room itself does not comply with ATEX, housing the mill inside an isolator can meet ATEX criteria inside the isolator.
The mill is integrated with the Isolator with the help of a body flange. The physical division of the cone mill head by the technical area left outside the isolator is made possible by this mounting flange and the specific layout of the cone mill.
The high-sealing coating equipment is mostly used for coating API high-active ingredients on tablets.
IPQC isolator is used for testing tablets or capsules in the production area for QC (Quality Control) analysis and approval.
The operator may correct any tablet process line packaging irregularities in a safe, hygienic, and totally contained environment using these high integrity barrier isolators, which are an intrinsic part of the tablet blister packaging machine.