Container closure integrity and headspace content verification are two solutions to ensure parenteral product stability and sterility maintenance.
Any modification in the headspace pressure, moisture or oxygen level may result in the degradation of the active drug, likewise in the reduction of drug potency and product shelf life.
Specific requirements for sterile drugs packaged under full or partial vacuum are covered by EU GMP Annex 1. “Manufacture of Sterile Medicinal Products”, section 123: “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period”. Beyond that, new regulations are expected to enter into force as revised USP <1207> “Sterile Product/Package Integrity Evaluation”, including specific measures to demonstrate the maintenance of sterility over time for drug products into controlled headspace gas packaging.
Bonfiglioli Engineering laser based Headspace Gas Analysis (HGA) is a complete solution to inspect commercial sterile drug products packaged under modified atmosphere or vacuum as Oxygen sensitive and Lyophilized:
Investigation of the closure integrity of pharmaceutical finished containers
Verification of critical headspace maintenance.The headspace measurement is non-destructive and non-invasive; it uses a technique known as Tunable Diode Laser
Absorption Spectroscopy (TDLAS), that is a spectroscopic method allowing the detection and quantification of gaseous components concentration.