CONTAINMENT TECHNOLOGY BY THE USE OF BARRIER ISOLATORS.
The Concept of Isolators was originally derived by the “Nuclear Industry” in order to keep the operators safe from radioactive Isotopes. Eventually this technology was adopted into the pharmaceutical industry to address operator safety from highly potent API’s. After years of evolution & upgrades the Barrier Isolators are looked upon as safer, easier & cheaper alternatives for handling High Potent API’s (Hormones, Cytotoxic, etc.).
Isolators provide a contained & controlled environment on a smaller scale compared to a clean room. The result is achieving ergonomic operation in an almost germ / contaminants free working atmosphere. All of this is achieved at a much smaller scale with minimized cost of cleaning, air cycles, validation & maintenance in comparison to a clean room.
At Chamunda Containment Solution’s we understand the need of the ever evolving API market to handle API drugs with maximum safety with comparative minimum cost of handling. We are deriving systems which are capable of handling wet, dry mass & Liquid from a range of OEL 3 to OEL 5. We are backed up by consultants from Europe who guides us in achieving the desired goal.
Chamunda has a complete setup for design & manufacturing of both Process equipment’s & Isolators in house. This provides us with absolute control over customization & equipment integration with Rigid Isolators*.
Our Product Range consists of the following.
- Sampling & Dispensing Isolator.
- Isolator for Granulation.
- Isolator for Roll compactor & dry process line.
- Isolator for Auto coater.
- Close loop Granulation lines.
- Colloid mill with containment.
- Integrated process equipment’s with Rigid –ve pressure Barrier Isolators
- Options for material ingress i.e. Pass Box, RTP’s & SBV’s
- Options for material discharge i.e. Out Pass Box, RTP’s, SBV’s, and Continuous Liners or BIBO Sleeves.
- In Process Containers with SBV’s.
- Pressure controlled cycles with Temperature, Humidity & O2 monitoring & control if required.
- Integrated WIP systems with Skid.
- Drum loading systems.
- Safe Change filters.
- Glove integrity testing.
- Optimum ergonomics via ergo trials.
- Complete automation using PLC + HMI (10”- Mitsubishi / optional Siemens make), compliant to 21 CFR if required.
- Support for pressure test OEL test provided.
- In compliance with cGMP norms.