Introduction

Dissolution testing of hazardous drugs, such as cytostatics, neuroleptics, hormones and antibiotics, demands rigorous requirements on work safety procedures and waste management. Remarkably, material handling at any stage of the conventional dissolution test may carry a substantial risk of contamination of the work bench, test equipment and personnel. Consequently, we have developed disposable and hermetic dissolution vessels for analysis and disposition of hazardous drugs with the aim to eliminate any potential sources of contamination.

The Cyto Vessel – hermetic system was developed considering the pharmacopoeial requirements of the USP apparatus 2 and it was manufactured using injection moulding. All materials used for the construction of the device are recyclable or can be disposed of by incineration. The device is composed of a dissolution vessel tightly attached to an evaporation lid. The paddle is joined with the evaporation lid using slip rings. The vessel is equipped with ports and plugs enabling the introduction of a dosage form, contamination free sampling and media conditioning. The construction of this disposable vessel enables its use with the commonly used dissolution testers. The device was evaluated according to the guidelines on mechanical and chemical calibration of dissolution testers.

The vessel material is impermeable for model substances and drugs tested. The results of the mechanical and chemical calibration testing of the device attest its compliance with regulatory guidelines on dissolution testing. The disposable dissolution test equipment developed effectively prevents contamination of the work place and excessive exposition of the personnel to contaminants. This innovative product enables the dissolution testing and disposal of toxic substances under standard lab conditions without dedicated infrastructure.

 

Product features:

  • Contamination-free dissolution testing
  • Suitable for closed loop analysis and contamination-free offline sampling
  • Prevents contamination of work bench and personnel
  • Facilitates rational waste management
  • Compliant with pharmacopoeial regulations and GLP guidelines