Pharmaceutical isolators are indispensable in the pharmaceutical and fine chemical industries, especially when dealing with APIs, high potency pharmaceutical ingredients (HPAPIs), and hazardous chemicals.
These sophisticated pharmaceutical containment solutions are designed to comply with current Good Manufacturing Practices (cGMP) and adhere to strict industry regulations and standards (such as for example EU GMP Annex 1, FDA 21 CFR Part 211, or ISO 14644).
Their primary function is to create a sealed, controlled environment that ensures both operator safety and product integrity by effectively isolating the process and protecting it from airborne contaminants.
Construction Materials: mainly crafted from AISI 316L stainless steel for pharmaceutical isolator chambers and internal components.
For high corrosives substances the structure of the isolator can be made of C22 (Hastelloy) or coated stainless steel (coating depending on the application).
Advanced Filtration: equipped with High-Efficiency Particulate Air (HEPA) filters to maintain a clean, contaminant-free environment.
Production-wise design: FPS Pharma’s pharmaceutical isolators can be either fixed or movable to ensure optimal operational efficiency. FPS Pharma’s custom design integrates seamlessly into production facilities, optimizing ergonomics for operator comfort and efficiency.
Monitoring and Cleaning Systems: pharmaceutical isolators are equipped with automated pressure leak tests, CIP or WIP cleaning systems, SIP (sterilization in place) systems, and continuous environmental monitoring to ensure the required conditions.
RTP and Material Transfer Systems: Rapid Transfer Ports (RTP) and high integrity transfer systems guarantee the utmost safety in transferring materials in and out of the isolator as well as from one chamber to the other.
Glove Ports or Robotics: pharmaceutical compounds, liquids and HPAPIs inside the isolator can be manipulated and processed in two ways:
ATEX / IECEx and UL versions: necessary for potentially explosive atmosphere.
Pharmaceutical manufacturing generally involves two primary processes: aseptic production and the handling of toxic substances. Each process requires different isolator configurations to address its specific needs.
Operate under negative pressure to contain hazardous substances.
Critical for processing, micronizing, weighting and dispensing HPAPIs and other volatile toxic materials, safeguarding the operators.
Operate under positive pressure to prevent product contamination.
Ensure a sterile environment, essential for aseptic applications and sterile products.
Aseptic Containment Isolators for Sterile and Toxic Substances:
Specifically designed to meet the unique requirements of sterile processes involving toxic compounds or liquids.
Maintain sterility while protecting operators from exposure to hazardous substances like HPAPIs.
