A global surgical glove manufacturer required comprehensive validation of its gamma irradiation sterilization process to establish a reproducible and controlled sterilization cycle. Pinnacle Therapeutics conducted process validation in accordance with ISO 11137 principles, evaluating dose delivery and process performance to support consistent sterility assurance. The study demonstrates how a structured validation approach can help manufacturers strengthen QC systems, regulatory readiness, and confidence in routine sterilization.

Client:

Global Surgical Glove Manufacturer (Confidential)

Objective:

To conduct comprehensive process validation of the gamma irradiation sterilization cycle for surgical gloves, ensuring compliance with ISO 11137 standards and regulatory expectations.

Background:

The client needed to validate the sterilization process for a newly established production site to:

• Meet global regulatory requirements (FDA, EU MDR)

• Ensure Sterility Assurance Level (SAL) of 10⁻⁶

• Support CE marking and U.S. market entry

Challenges:

• Tight project timeline to align with product launch

• Lack of prior dose validation history for new glove material

• Need to coordinate between manufacturing, QA, and external irradiation facility

Approach:

1. Installation & Operational Qualification (IQ/OQ):

• Verified irradiation equipment setup, control system, and calibration

• Reviewed facility utilities (power, shielding, automation)

2. Bioburden Testing:

• Collected glove samples from multiple production batches

• Measured microbial load on product surfaces

• Identified worst-case microbial contamination level

3. Dose Auditing & Verification:

• Calculated verification dose using the VDmax method

• Exposed gloves to the verification dose

• Performed sterility testing on 100 units as per ISO 11737-2

4. Performance Qualification (PQ):

• Conducted 3 successful sterilization runs using full production loads

• Used dosimeters and biological indicators to confirm dose uniformity and sterility

5. Documentation & Reporting:

• Generated full Validation Master Plan (VMP)

• Submitted validation summary report, dose mapping data, bioburden reports, and SAL justification

Results:

• All sterility tests passed for the verification dose

• Dose distribution within required range

• SAL 10⁻⁶ achieved and validated

• Validation completed 2 weeks ahead of schedule

• Approved by internal QA and external notified body

Client Benefit:

• Enabled rapid product registration in the EU and U.S.

• Ensured patient safety and product quality

• Reduced compliance risks with audit-ready documentation

• Enhanced confidence in new site’s sterilization capability