Ensuring Contamination Control in Radiopharmaceutical and Pharmaceutical Manufacturing

The Vital Role of Speedy Glove in Glove Integrity Testing

Introduction

Maintaining aseptic conditions in Radiopharmaceutical and Pharmaceutical manufacturing is critical to prevent contamination. Barrier separation technology, such as isolators and Restricted Access Barrier Systems (RABS), rely on glove-sleeve systems to maintain sterility. However, these gloves are susceptible to wear and tear and other damages, leading to potential contamination risks if not properly managed. This post discusses how Speedy Glove, an advanced glove integrity tester from Comecer Netherlands, ensures compliance with GMP Annex 1 and ISO 14644-7 standards, thereby enhancing contamination control in (radio) pharmaceutical environments.

Glove Integrity Challenges

Barrier glove-sleeve systems are integral to maintaining aseptic conditions but are prone to damage and wear and tear. This damage often goes undetected through visual inspections alone, posing significant contamination risks. Studies indicate that glove pinholes can allow microbiological contamination, especially during critical process interventions. 

Regulatory Requirements

The revised GMP Annex 1 and ISO 14644-7 standards emphasize rigorous testing of glove integrity before and after each production batch. The standards highlight the necessity of both physical and visual inspections, with a preference for automated, reliable testing methods to detect even the smallest leaks.

Speedy Glove Solution

Speedy Glove addresses these regulatory requirements by offering a portable, flexible and automated glove integrity tester that utilizes the Positive Pressure Decay Method. This method involves inflating the gloves to a set pressure, stabilizing it, and measuring the pressure decay to detect leaks. 

Key Features

• SPEED: Rapid inflation phase, 60 times faster than conventional devices.
• FLEXIBILITY: Adaptable to various glove types and flanges with customizable adapters.
• AUTOMATION: RFID technology for automatic recognition and parameter loading.
• PRECISION: Detects leaks accurately, ensuring compliance with GMP and ISO standards.
  
  
  

Testing Process

The Speedy Glove testing process comprises three stages:

• INFLATION: Gloves are inflated to the required pressure.
• STABILIZATION: Pressure is maintained to minimize elastic effects.
• MEASUREMENT: Pressure decay is measured to detect any leaks.

The device generates detailed reports compliant with FDA CFR 21 Part 11 and GMP Annex 11, ensuring traceability and regulatory compliance.

Benefits of Speedy Glove

COMPLIANCE: Helps you meet GMP Annex 1 and ISO 14644-7 standards.

EFFICIENCY: Reduces testing time with fast and reliable results.

NON-DESTRUCTIVE TESTING: Uses certifed calibrated valve to simulate damage without harming gloves.

USER-FRIENDLY: Easy to operate with minimal training, integrating seamlessly into existing workflows.

Implementation in Glove Management Strategy

A robust glove management strategy includes periodic glove replacement, regular integrity testing, and responsive actions to detected leaks. Speedy Glove's automated testing and detailed reporting facilitates this strategy, ensuring continuous compliance and minimizing contamination risks. The availability of its Management and Control software, central management of test data, configuration of test campaigns and test parameter management, completes this strategy. 

Conclusion

Speedy Glove revolutionizes glove integrity testing in (radio)pharmaceutical manufacturing by combining speed, precision, and compliance with general management of your glove test strategy. It is an essential tool for maintaining aseptic conditions and ensuring product safety. By integrating Speedy Glove into your glove management strategy, you can confidently meet regulatory requirements and enhance contamination control.

For more information on Speedy Glove and its benefits, visit Comecer’s website: www.comecer.com