In aseptic manufacturing, glove testing has always been a weak link in maintaining microbial integrity for barrier systems such as isolators and RABS. Any undetected micro-defects may evolve into a fatal path leading to product contamination.

For this reason, EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” places unprecedented emphasis on glove integrity. The regulation requires that enterprises’ Contamination Control Strategy (CCS) must fully consider the potential impact of barrier or glove integrity breaches during risk assessment. Meanwhile, it also provides clear guidelines on testing methods and frequency.

According to EU GMP Annex 1, 22.8.2022 C(2022) 5938 final:

4.21 The materials used for glove systems (for both isolators and RABS), should be demonstrated to have appropriate mechanical and chemical resistance. The frequency of glove replacement should be defined within the CCS.

• “For isolators, leak testing of the glove system should be performed using a methodology demonstrated to be suitable for the task and criticality. The testing should be performed at defined intervals. Generally glove integrity testing should be performed at a minimum frequency of the beginning and end of each batch or campaign. Additional glove integrity testing may be necessary depending on the validated campaign length.”
• “For RABS, gloves should be visually examined with each use, and integrity testing should be performed at periodic intervals.”

Reference: https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf

It is evident that traditional experience-based testing methods can no longer meet compliance requirements. A systematic, high-frequency, and data-traceable testing model will become the mainstream practice in the industry. The Parenteral Drug Association (PDA) points out that modern glove testing systems should be designed to meet the requirements of “Pharma 4.0” for control connectivity, reporting, and data integrity management.

To better address regulatory requirements and industry trends, Tailin has launched the next generation of its Wireless Glove Integrity Tester – the GIT-WLAN03.

Guided by the “Quality by Design (QbD)” concept, this product achieves wireless device communication, paperless data, and in-situ testing through wireless communication and intelligent software technology. The testing system supports multi-device group control and data interconnection, automatically generates electronic test reports that comply with GMP requirements, and builds a closed-loop data ecosystem covering the entire process.

PART 01: Building a Solid Foundation for Trustworthy Data with the ALCOA+ Principle

The testing system strictly adheres to the industry-recognized ALCOA+ principle, ensuring all data meets the following characteristics:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate
• +(Complete, Consistent, Durable, Accessible)

PART 02: From Data Management Principles to System Advantages

Benefiting from the integration of wireless communication and self-developed SCADA (Supervisory Control and Data Acquisition) Management Software functions, the compliance of test data can be guaranteed even when the device is in remote communication status:

Full-Process Audit Trail for “Integraty (I)” and “Contemporaneity (C)”

The system has a built-in tamper-proof audit log function. Every operation—from user login, parameter setting to test report generation—is fully recorded. The log file includes key fields such as timestamp, operating user, specific operation, and electronic signature notes, ensuring all activities are traceable.

Chained Electronic Signatures and Multi-Dimensional Access Control for “Attributability (A)”

• Electronic Signatures: Critical operations (e.g., formula modification) must be authenticated via signature. The review and approval of test reports are completed online, forming a clear chain of responsibility traceability.
• Access Security: The system adopts a four-layer mechanism—unique user ID, password, account validity control, login failure lockout, and automatic timeout lockout—to ensure only authorized personnel can perform corresponding operations.

Independent Identity Authentication for Accurate Group Testing Data

In group testing mode, each tester is equipped with an independent user login function. Therefore, even when operating multiple devices simultaneously, the central management software can accurately track the operator information for each device, implementing “attributability” of data in every detail.

Intelligent Database for “Accessibility” and “Durability” of Data

The system uses a professional SQL Server Database to archive and store all process data. Users can not only customize backup plans to ensure long-term storage but also leverage powerful multi-dimensional query functions to quickly retrieve historical data and logs by criteria such as time, device, operator, and test results—making data accessible whenever needed.

PART 03: From Reliable Data to Intelligent Decision-Making

Complete and reliable test data can provide important basis for quality decisions, supporting the maintenance and improvement of management systems:

• Establishing Glove Performance Trend Profiles: Through systematic analysis of historical data, enterprises can establish glove performance trend profiles. This not only provides a scientific basis for formulating data-driven glove maintenance and replacement plans but also serves as key input to integrate into and continuously optimize the overall contamination control strategy of barrier systems.
• Deviation Investigation and CAPA: When deviations occur in glove integrity, complete and traceable data is critical for investigation. The accurate logs and test records provided by the system help the quality team quickly conduct Root Cause Analysis (RCA) and provide solid data support for formulating effective Corrective and Preventive Actions (CAPA), thus forming a closed loop for continuous improvement.

PART 04: Building a Bridge Between Data and Security

Against the backdrop of increasingly stringent industry regulations and compliance requirements, glove integrity testers are not only testing tools but also key guarantees for enterprises’ compliance management. With electronic signature and audit trail functions, the product provides the industry with an efficient, intelligent, and compliant solution, supporting enterprises in safe, efficient, and compliant production and operation.

Contact us: marketing@tailingood.com