Improved pharmaceutical packaging
with ALD

Picosun study

Picosun studied ALD coating for enhanced hydrolytic resistance and as barrier against leachables. The study included head-to-head comparison of uncoated reference type I vial (Schott Fiolax borosilicate glass) and four different ALD coatings on the same vial type.

Acceleration tests were done according to USP660 & ISO 4802-1 and USP 1660 recommendations in an accredited third-party laboratory

• Water (heating profile: 121 ± 1 °C for 60 ± 1 min as per USP <660>)
• 3% Citric Acid (adjusted to pH 8, heating profile: 24 hours at 80°C)
• 20mM Glycine (adjusted to pH 10, heating profile: 24 hours at 50°C)

Analysis methods

• ICP-OES for extractable concentrations
• ISO 4802-1 titration for hydrolytic resistance
• SEM images of the vial surface and leached element count
  
  

ALD COATED TYPE-I BOROSILICATE VIAL SHOWED -90% REDUCTION IN LEACHED ELEMENT FORMATION vs STANDARD TYPE

Example of results: Titration for hydrolytic resistance

Resistance to the release of soluble mineral substances into water under the prescribed conditions of contact between the glass and water

Titrations were done with over 10 vials in total per material.

Results showed way over 10x improvement in the hydrolytic resistance for best ALD coated vials as compared to non coated vials.