Influence of Packaging Material and Design on the Microbial Quality and Cost Structure of Nonsterile Pharmaceutical Products

Background:

Pharmaceutical product safety requires packaging that limits microbial entry while remaining cost-effective.

Objectives:

This study evaluated the influence of nonsterile oral pharmaceutical products’ (paracetamol) packaging choice on microbial safety and product cost, and demonstrated the propensity to contamination over a 6-day active use period.

Materials and Methods:

A total of 160 packages of 100 mL paracetamol syrup samples were analysed across four experimental configurations combining different package materials and orifice diameters. A longitudinal, single-group time-series design was adopted for multiple-packaged paracetamol tablets to track contamination. Total viable aerobic counts (colony forming unit/millilitres) were determined using the standard pour plate technique after 48 hr of incubation.

Results:

Statistical evaluations: Two-Way Analysis of Variance, independent-samples t-tests, variance partitioning, and Pearson correlation coefficients at a significance threshold of α ≤ 0.05, indicated significant main effects for experimental configuration (F=34.86, p<0.001) and active-use-time (F=288.77, p<0.001), with a significant interaction effect (F=8.19, p<0.001). Pooled by material type, glass showed a significantly more effective contamination barrier compared to plastic. Regression modelling for the 6-day active exposure of tablets package revealed a significant positive linear trend (F_{1, 38}=72.28, p<0.0001). Cost analysis showed glass carries a substantial pricing premium compared to plastic.

Conclusion:

Contamination containment in nonsterile products is not restricted to the use of preservatives alone. A clear trade-off exists between product costs and preservation performance. This challenges the current lack of descriptive label procedures for product active use based on package type and design.