In-Use, Compatibility and Ruggedness

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In-Use Stability Studies

The appropriate physical, chemical and microbial properties of the product susceptible to change during administration should be determined over the course of withdrawal—from the primary container/closure system through mixing with other diluent or drug product(s)—to final administration with relevant delivery devices.

Examples of the In-use Stability Study include:

  • Administration with disposable syringes
  • Administration with IV catheter with or without in-line filter
  • Dilution with IV infusion bag
  • Stability and integrity of multidose formulation over multiple entry

Compatibility Study

Since it comes in contact with other materials, molecules, etc., the drug product’s stability and integrity needs to be demonstrated. The following is a list of the types of compatibility studies we often undertake:

  • Prefilled syringe compatibility study
  • Extractables and leachables study
  • Secondary container/closure systems
  • Excipient-drug compatibility
  • Drug-drug compatibility study

Formulation Ruggedness Study

After formulation is identified, the stability of the drug product within the specification of each formulation parameter needs to be generated. In addition, the effect of various excursions from controlled stability study conditions on product stability has to be studied. Examples of the ruggedness study include:

  • Formulation ruggedness study
  • Transportation study
  • Process excursion study
  • Temperature excursion study