Common Pitfalls in Packaging Validations (and How to Avoid Them)

As regulatory expectations evolve, packaging validations are facing greater scrutiny. Many deficiencies flagged by auditors trace back to recurring pitfalls: inadequate planning, missing acceptance criteria, or weak justification for validation strategies. Other challenges include insufficient sample sizes, overlooking worst-case conditions, and gaps in sterilization timing or aging studies. Even minor design or process changes, if not properly addressed, can undermine compliance. In this Expert Insight, Logan Luke, Expert Technical Consultant at Nelson Labs, shares guidance on avoiding these missteps. He stresses the importance of grounding validation strategies in ISO 11607-1 and -2, as well as ISO 16775, and advises companies to question inherited processes while working with trusted partners. Looking ahead, Logan highlights two emerging pressures: innovative sterile barrier designs that don’t easily “fit the mold” and the industry’s increasing focus on sustainability. Both trends, he notes, will demand innovative approaches to ensure packaging validations remain thorough and effective.