Positive & Negative containment solutions ensuring utmost protection of product, personnel and environment
Design, Construction and Commissioning - HVAX specialises in the containment of airborne particles often present when handling drug compounds in Pharma, Biotech and allied applications, and has a team that has years of experience in the supply of proven containment solutions.
Containment has become an extremely important aspect of every production process. With Active pharmaceutical ingredients (APIs) becoming ever more effective and powerful, with more than 50% of all new chemical entities (NCEs) being classified as potent (OEL <10 μg/m3); at the same time, the health and protection of operators, all over the world, is being put under an increasingly powerful limelight. Searching through the Navigating the network of available hardware manufacturers and many containment methods has made it more difficult to select the most appropriate equipment that keeps the product, personnel and environment safe.
The manufacturing of oncology drugs, hormonal products and / or other highly potent combinations needs specific attention: it is vital to avoid exposure of the operators to the drug as well as prevent the cross-contamination of other products manufactured in the same facility.
|BAND||OEB 1||OEB 2||OEB 3||OEB 4||OEB 5||OEB 6||OEB 7|
|OEL||>1000 - 5000 µg/m3||>100 - ≤1000 µg/m3||>10 - ≤100 µg/m3||>1 - ≤10 µg/mv3||<1.0 - 0.01 µg/m3||0.01 - 0.001 µg/m3||<0.001 µg/m3 - <1 ng/m3|
|Equipment to Use||Ventilation Containment||Ventilation Containment or Flowhoods without downflow (single pass Fume cabinets)||Downflow Booths or VBEs, Flowhoods||VBEs or DFBs with higher containment, Flowhoods with downflow and inflow for small volume||Isolators recommended however if handling less than 3kg and short task duration, low dust cloud potential reverse oRABs possible||Isolators||Isolators|
Process Machine Integrated Solutions
We offer a wide range of containment solutions depending upon nature of drug and containment philosophy. From humble glove box designs to completely combined complex process systems which meet and comply up to OEL 5 Successfully. HVAX can integrate any customized process like dispensing, sampling, reactor charging, discharging, milling, sieving, blending, granulation in API and Formulations.
- Automated leak testing
- Dedicated AHU system connected with PLC
- Mobile CIP process support skid
- ERGONOMIC Model study and approval
- Waste and drain management with disposal SOP
- 21 CFR Part 11 compliance /GAMP/ SCADA system
You may avail our containment consultancy for more details on our methodologies.