Single Use Filling Needles: Simplifying Filling of Small Volume Parenterals

A number of steps in the Biopharmaceutical manufacturing are increasingly moving towards disposable technology approaches, to enhance operational flexibility and to reduce capital investments in equipment.

MDI is striving to provide promising single-use alternatives in the biopharmaceutical manufacturing processes with its high level of application specific customization. Working on the same tangent MDI has developed a new single use product – Disposable filling needles.

The MDI single use filling needle offers ready to use and completely disposable filling solutions. It obviates the cost and resources required for filling needle cleaning verification and validation. It increases available operator time and decreases down time of filling machines and associated equipments. Some of the unique performance advantages are :

  • No drip formation, cavitation, or bubble formation during filling
  • Accurate and reproducible dose volumes
  • Accurate dosing for different surface tensions, densities, and viscosities
  • Two different internal diameters to facilitate different fill volumes
  • Facilitates easy integration in filling line/systems with female luer/hose barb connection

MDI also offers customized needles for specific process needs. Please contact for your special needs.

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PUPSIT: Pre-use/ Post Sterilization Integrity Testing of Sterilizing Filters

Manufacture of sterile drug products using sterilizing filters mandates that the drug product is filtered through an integral filter, failing which passage of microbial contamination is an eventuality that poses a high risk to the patient. Regulatory bodies such as US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) make it mandatory to carry out post filtration integrity testing of the filter. However, pre-use/ post sterilization integrity testing (PUPSIT) is not an essential requirement by all regulatory bodies.

This has led to a worldwide discussion on the necessity of PUPSIT and different groups have been trying to address other issues taking different approaches.

A latest approach has been to investigate post filtration masking of integrity failure of sterilizing filters due to clogging. It was found that in certain drug products there is a significant increase in the postuse bubble point values over the preuse values that may lead to concealing of possible defects in the sterilizing filter. An article published in  PDA Journal of Pharmaceutical Science and Technology Vol.74, Issue 3, May/ June 2020 throws more light on this.

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