Navigating defects: PoD studies on vials

These studies gather crucial data to refine inspection processes and ensure product integrity. In this article, we delve into a PoD study eyetec conducted on 1 mL AT vials and 2 mL CZ vials with a low fill volume of 0.3 mL, shedding light on its significance and findings. 

Scope 

The primary objective of this PoD study was to assess the probability of detecting mobile particle defects in the specified vial types. Test sets for each vial type were meticulously inspected 30 times by a minimum of 3 qualified operators. The production of the test set samples was conducted by eyetec in clean and protective conditions under laminar airflow to prevent contamination. The defect samples in the test sets contained particle defects selected from 5 industry standard material types. To minimize the effect of production variation on these particle defects, multiple samples of each material/size combination were made, together with an excessive amount of good vials, to complete the set. This meticulous approach ensured comprehensive coverage and accuracy in assessing the detection probability of mobile particle defects in the specified vial types. 

Types of vials 

• AT vial 
• CZ vial

Conclusion 

Fibers present significant challenges in detection, particularly due to their static properties and tendency to adhere to vial surfaces. Their long, narrow structure and varying visibility based on the inspection angle further complicate detection. Therefore, tailoring inspection methods to the specific characteristics of each vial type is crucial for enhancing detection accuracy. For AT vials and CZ vials, optimizing the inspection method requires different approaches. 

Type Of Defects | Detection Rate 

• Transparent plastic: 

  

• White plastic:  
  
  
• Dark colored rubber:
  
  
•  Stainless steel:
  
  

• Light colored fiber:
  
   

PoD studies are integral to maintaining product integrity and meeting industry standards in pharmaceutical manufacturing. Through meticulous assessments and analysis of detection probabilities, eyetec contributes to enhancing inspection methods and improving overall product quality.