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PubMedDate not supplied

An automated method for vacuum testing pharmaceutical vials.

A new automated vacuum tester which applies a high voltage, high frequency electric field and a stroboscopic flash to conveyorized vials was found to yield zero percent false rejections of lyophilized vials with internal pressures of less than 62 Torr. The hand-held testing device used until now was found to produce, on extended contact with vials containing sensitive protein product, excessively high numbers of particulates upon drug reconstitution. In the automated machine operating at rates between 150 and 30 vials per minute, each vial is exposed for only 0.3 to 1.4 seconds and sensitive products emerge undamaged.

Automation↗

PubMedDate not supplied

Time-dependence of pressure in lyophilization vials.

Lyophilized pharmaceuticals are often sealed under reduced pressure and "vacuum testing" is done as a part of quality assurance. In this work the pressure Pv inside lyophilization vials was measured as a function of storage time after sealing at a chamber pressure Pc < 20 mtorr. Vials were of 50 mL nominal capacity (empty and with product) and 10 mL nominal capacity (with product). For all three sample types Pv was observed to rise to approximately 2 torr within ca. 50 hrs, then increase slowly to Pv = 5-10 torr after the lapse of 2300 hrs (3 months). Calculations based on outgassing and permeation of the stopper by O2, NH2 and H2O demonstrate that vial pressure is primarily due to desorption of water vapor from the stopper into the headspace of the vial. The presence of a hydrophilic product decreases the rate of pressure rise, and Pv increases more rapidly in smaller vials. Results are discussed in terms of testing for seal integrity and for stopper effects on moisture in the product.

Drug Storage↗