MDI Disposable Single Use Filling Lines

The current therapeutic healthcare is becoming more and more focused on highly potent, high-value drugs from both the biopharmaceutical as well as the pharmaceutical industry. This has resulted in a continuous stream of new drug products with smaller lot sizes, requiring quick turnaround times and thereby challenging the existing reusable Fill Finish systems with time and manpower-consuming cleaning and sterilization processes.

MDI disposable single-use filling lines offer customized solutions for final fill of drug products, overcoming flexibility and productivity constraints associated with traditional fill and finish systems.

These ready to use, gamma sterilized filling assemblies are designed to not only ensure regulatory compliance but also enhance product and operator safety.

MDI disposable single-use final fill assemblies ensure:

  • Quick turnaround time
  • Product and operator safety
  • Reduced risk of cross-contamination
  • No cleaning validation
  • Increased flexibility and productivity

MDI single-use filling lines are customized to suit new as well as existing fill and finish systems. These are designed to comply with regulatory requirements such as “Final sterile filtration should be carried out as close as possible to the filling point” and “The integrity of the sterilized filter should be verified before use and should be confirmed immediately after use by an appropriate method such as a bubble point, diffusive flow or pressure hold test” (European Union Current Good Manufacturing Practices).

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MDI ASESS Aseptic Sampling Systems

  • ASESS: Aseptic Sampling Systems

MDI ASESS Aseptic Sampling System is designed for sampling biopharmaceuticals and other process fluids for analytical purposes such as:

  • Bio-burden
  • Endotoxin
  • Sterility Testing
  • pH Testing
  • Chemical Analysis

The Aseptic Closed Sampling Systems are used to achieve multiple sampling from sterile containers such as process vessels and bioreactors while complying with regulatory guidelines

Unique Features:

  • Closed system: Prevents extraneous contamination
  • Artifacts free clean system
  • Personnel safety from biohazardous and cytotoxic fluids
  • Cost advantage through customization
  • Easy and aseptic sampling for different tests

Asess sampling port is available with the following needles:

Customization:

ASESS Aseptic Sampling Systems can be customized to suit user requirements regarding the number and type of sampling containers such as bags, bottles, and centrifugal tubes.

A technical feasibility of the required design is established based on available components and an initial drawing is proposed. Product prototyping and final approval leads to customized system realization.

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