Isolator Technology for Pharmaceutical Formulation

The isolator was designed with specific applications in mind, tailored to meet the unique needs of Bio-Manguinhos’ formulation processes. Featuring a large EU-GMP Class A (ISO 5) production chamber, our isolator ensures an ultra-clean, controlled environment, offering unmatched protection for sensitive operations.

Main specifications of the formulation isolator

• The highest safety level is guaranteed through a large EU-GMP Class A (ISO 5) production chamber.
• Integrated skanfog® technology enables fast decontamination cycles.
• Increased flexibility for individual applications through a combination of different transfer solutions.
• Up to three sara (safe and rapid airlocks) can be attached to the production chamber.

Processes of the formulation isolator for Bio-Manguinhos

• Design and accessibility

  The entire chamber is accessible from both sides, enabling smooth, cross-operational production flows for efficient collaboration.

• HMI (human machine interface)

  The intuitive, user-friendly HMI system simplifies operator control and monitoring for the entire process.

• sara airlocks

  Independent sara airlocks allow fast material transfer into the sterile environment without interrupting production.

• skanfog and SKAN nanox

  Advanced hydrogen peroxide decontamination with skanfog ensures rapid decontamination. The integrated SKAN nanox catalyst neutralizes the used H₂O₂ for a safe working environment.

  The isolator was designed with specific applications in mind, tailored to meet the unique needs of Bio-Manguinhos’ formulation processes. Featuring a large EU-GMP Class A (ISO 5) production chamber, our isolator ensures an ultra-clean, controlled environment, offering unmatched protection for sensitive operations.

  Main specifications of the formulation isolator

  • The highest safety level is guaranteed through a large EU-GMP Class A (ISO 5) production chamber.
  • Integrated skanfog® technology enables fast decontamination cycles.
  • Increased flexibility for individual applications through a combination of different transfer solutions.
  • Up to three sara (safe and rapid airlocks) can be attached to the production chamber.
• Magnetic stirrers

  Integrated magnetic stirrers ensure continuous, controlled agitation for formulation integrity.

• Peristaltic pumps

  Peristaltic pumps enable easy fractioning and accurate dosing of liquids, ensuring precise formulation production.

• Viable and non-viable particle counters

  Particle counters monitor both viable and non-viable particles to ensure product safety.

• Sterile Air Recirculation Technology (SART) System™

  One of the standout features of our isolators is the SART System™, which ensures aseptic liquid transfer directly into the isolator, preserving ingredient sterility during critical processes.

• Rapid transfer ports (RTP)

  The RTP system enables the aseptic transfer of smaller materials in and out of the isolator.

• External peristaltic pumps

  External pumps support the fractioning of high-volume liquids while maintaining aseptic conditions during inflow and outflow.

More impressions of the custom built isolator: