Hospital preparation of sterile vaseline oil: a rapid response to a worldwide shortage

Background
Vaseline oil, i.e. light liquid paraffin oil (HP2L), CAS 8012-95-1 (monograph 07/2018:0240)(1) sterile used in several therapeutic indications (e.g., adjuvant treatment of burns; skin grafting; lubricant for catheter insertion) is the subject of a worldwide production and distribution stoppage. A feasibility and risk analysis was carried out to validate a production method and specify the physico-chemical and microbiological controls for a sterile HP2L hospital preparation.

Materials and methods
Non-sterile HP2L was aseptically dispensed into sterile amber type I vials (50 mL). Bacillus stearothermophilus spores adsorbed on strips were introduced into these vials before autoclaving at 121°C (HP2L flash point = 149°C) for 1 hour (2)(3)(4). After sterilisation, the strips were inoculated into a culture medium (Tryptone-Soya broth) and incubated at 55°C and 60°C for 7 days. Control vials of (i) non-sterilised HP2L containing spores, (ii) culture medium with and without spores (positive and negative controls, respectively) were incubated as described above. Rheological, particle count (visible and non-visible) and microbiological controls were carried out at the end of production.

Results and Discussion
The microbiological results confirmed the effectiveness of the sterilisation process, with no bacterial growth in the autoclaved bottles. Rheological analysis showed no change in the apparent viscosity of HP2L after autoclaving (25 mPa-s to 80 mPa-s). Particle counts were in accordance with parenteral drug specifications. Wet sterilisation was chosen due to the flash point of HP2L.

Conclusion
This study illustrates the importance of hospital preparations in the therapeutic arsenal, particularly in a situation where there is a global shortage of (i) innovative, high added-value drugs or (ii) drugs essential to medical practice.

Références
1 European Pharmacopoeia 11.5 – Paraffine liquide légère
2 Données de stérilisation du fournisseur précédent
3 The Upjohn Company, Kalamazoo, Michigan 49001 : Sterilization of Oils: Data to Support the Use of a Continuous Point-of-Use Sterilizer
4 Peer reviewes : Dry-Heat Sterilization of Parenteral Oil Vehicles

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