Top 3 Mistakes Pharmaceutical and Medical Device Companies Make During Sterilization Validation (and How to Avoid Them)

Sterilization validation is a critical step in ensuring the safety and effectiveness of pharmaceutical and medical device products. However, even the most experienced teams can make mistakes that delay processes, impact compliance, and risk product safety. In this article, we’ll highlight the top three mistakes pharma and med device companies make during sterilization validation and provide practical solutions to help you avoid them.

1. Neglecting to Choose the Right Biological Indicators

The Mistake: Many companies underestimate the importance of selecting the correct biological indicators (BIs) for their sterilization method. Using the wrong microorganisms or BIs with insufficient resistance can lead to inaccurate results, invalidating the entire sterilization validation process. 

Why It Matters: Biological indicators are the gold standard for validating sterilization processes. If they don’t accurately challenge your process, you risk non-compliance with regulatory standards (e.g., FDA, ISO 11138) and jeopardize product sterility. 

How to Avoid It: 

• Match the BI to Your Sterilization Method: 
  • Geobacillus stearothermophilus for steam and vaporized hydrogen peroxide (VH₂O₂). 
  • Bacillus atrophaeus for ethylene oxide (EO) and dry heat. 
• Verify Resistance Levels: Ensure the BI has the appropriate resistance characteristics to challenge your sterilization parameters effectively. The resistance of the BI must be greater than the product or bioburden resistance.
• Partner with Experts: Work with trusted suppliers like Mesa Labs to identify the best BIs for your application and ensure they meet regulatory standards. 

2. Overlooking Proper Placement of Biological Indicators

The Mistake: Companies often place biological indicators in easy-to-reach areas within the sterilizer load instead of the most challenging spots. This leads to an incomplete assessment of the sterilization process and creates a false sense of security. 

Why It Matters: Sterilization processes may have “cold spots” or areas where sterilant penetration is less effective. Failing to test these critical locations can result in undetected sterilization failures. 

How to Avoid It: 

• Identify Challenging Locations: Place BIs in areas where sterilant penetration is most difficult, such as: 
  • Dense or tightly packed load areas. 
  • Cold zones within the sterilizer. 
  • Sealed or hard-to-reach components. 
• Adopt Best Practices: Always test worst-case scenarios during validation runs to ensure the process is robust and reliable. 

3. Failing to Document and Analyze Results Thoroughly

The Mistake: Sterilization validation involves extensive testing, but companies sometimes fall short when it comes to thorough documentation and result analysis. Incomplete records or failure to investigate deviations can trigger audit findings, delays, or worse—non-compliance. 

Why It Matters: Regulatory bodies, such as the FDA and EMA, require detailed, accurate documentation to demonstrate that sterilization validation meets the required Sterility Assurance Level (SAL). Poor record-keeping can compromise regulatory compliance and product release timelines. 

How to Avoid It:

• Standardize Documentation: Implement a clear, step-by-step procedure for recording sterilization validation results, including: 
  • BI test outcomes (growth/no growth). 
  • Physical and chemical parameter data (temperature, pressure, exposure time). 
  • Any deviations or anomalies observed during the process. 

• Investigate Failures Promptly: If a BI shows growth, analyze the root cause and implement corrective actions before continuing validation. 
• Leverage Digital Tools: Use automated systems for data capture and reporting to minimize human error and ensure compliance with regulatory standards. 

Conclusion 

Sterilization validation is too important to leave to chance. By avoiding these common mistakes—selecting the wrong biological indicators, improper placement, and incomplete documentation—you can ensure compliance, protect patient safety, and streamline your processes. 

Partnering with Mesa Labs gives you access to trusted biological indicators, expert guidance, and the tools you need to validate and optimize your sterilization processes with confidence. Avoid costly mistakes and achieve sterilization success by working with the industry’s leading experts.