Containment Notes

Containment Solutions

Facts about Containment

  • Containment is a barrier technology.

  • It prevents contamination from the operator, product, or both.

  • Separation into three categories:

    • Product protection

    • Operator protection

    • Product and operator protection

Product Protection

  • Aseptic product.

  • GMP (Good Manufacturing Practice) requirements.

  • Positive Pressure Isolator.

Operator Protection

  • Toxic product.

  • Personal protection.

  • Negative Pressure Isolator.

Product and Operator Protection

  • Aseptic product (toxic).

  • GMP requirements.

  • Positive Pressure Isolator.

Containment Solutions Available

  • Workbench

  • Open RABS (Restricted Access Barrier System)

  • Closed RABS

  • Isolator

Choosing the Right Containment Solution

  • Factors to consider:

    • Workbench

    • oRABS (Open Restricted Access Barrier System)

    • cRABS (Closed Restricted Access Barrier System)

    • Isolator (including special designs)

    • Room conditions

    • CCS (Containment Control Strategy)

    • SOP (Standard Operating Procedure)

Need for Containment

  • To fulfill the latest Annex 1 guidelines.

    • Annex 1: The European Union’s guidelines for the manufacturing of sterile medicinal products.

  • To achieve a controlled sterile environment.

  • Safety reasons.

Importance of Containment

  • Customer needs a complete containment solution (interfaces between the provider and OEM, Original Equipment Manufacturer, is important).

  • Cleanability process (during normal conditions, handling of breakage, etc.).

  • CCS (Containment Control Strategy) in consultation with customer SOPs.

Conclusion

  • Customer process understanding is important to know.

  • Product knowledge is mandatory.

  • Consideration of existing containment solutions to identify preferred solutions.

  • Attention to details.