Biodeconta GISTOOL - 50 Glove Leak Tester and Validation Services Safeguard the Safety of Microbiological Laboratories

Recently, Biodeconta Decontamination Technology successfully secured a significant cooperation agreement, delivering the GISTOOL - 50 Glove Integrity Tester to a company operating in the biotechnology sector and simultaneously providing professional on - site 3Q validation services. As a preferred testing equipment for sterile production environments in China, the GISTOOL - 50 strictly complies with GMP standards and Annex E.5 of ISO 14644 - 7. It adopts the pressure decay method to ensure accurate and reliable test results. Equipped with a high - performance built - in battery and air pump, the device can operate independently in all scenarios. It supports customized flange sizes to adapt to various complex sterile environments, and the printer included with the standalone version facilitates easy data storage and traceability.

To ensure the rapid and compliant operation of the equipment, Biodeconta's senior technical team provides synchronized on - site 3Q validation services: Installation Qualification (IQ) verifies the completeness of equipment documentation, the suitability of the installation environment, and the compliance of components; Operational Qualification (OQ) tests the no - load stability of the equipment within extreme parameter ranges; and Performance Qualification (PQ) ultimately validates the equipment's detection accuracy and repeatability under actual operational conditions. The entire service strictly adheres to the compliance requirements of drug regulatory authorities, effectively eliminating potential risks in equipment operation. It provides reliable assurance for glove integrity testing in the company's sterile production processes and assists the enterprise in passing the critical stage of GMP certification.

The partner for which biodeconta delivered and validated the equipment this time is a large - scale biotechnology joint - stock group company based in Beijing. Boasting profound expertise in the core field of biotechnology, the enterprise focuses on the construction of sterile production systems and quality control, with mature technical capabilities and a comprehensive quality assurance mechanism covering the entire R&D and production chain of biological products.

Its business operations strictly adhere to domestic and international biopharmaceutical industry regulations, complying with high - standard systems such as GMP and ISO. It places particular emphasis on the integrity and reliability of sterile barriers in the production process — from the selection of key equipment to the implementation of testing procedures, the core objective is to ensure the safety and efficacy of biological products.

To meet the quality traceability and compliance requirements throughout the entire production cycle, the enterprise verifies the compliance of equipment performance through professional validation services before putting the equipment into use. This ensures that every production link meets industry regulatory standards, laying a solid quality foundation for the subsequent R&D transformation and large - scale production of products.

The enterprise has purchased the Biodeconta Glove Integrity Tester (GISTOOL - 50), which is specifically used to test the seal tightness of gloves on the isolators for sterile testing in its microbiology laboratory, preventing contamination risks caused by glove leaks.

As a sterile experimental site, the microbiology laboratory is constructed in accordance with GB 19489 General Requirements for Laboratory Biosafety. It mainly handles moderate - risk pathogenic microorganisms and must meet the dual standards of biosafety protection and sterile control simultaneously. In such laboratories, the sterile isolator is the core equipment for conducting operations with high contamination risks. Its glove system, as the key interface between personnel operations and the isolated environment, directly affects experimental safety and result reliability through its integrity.

Article 28 of the Annex to Sterile Drugs (Exposure Draft) clearly stipulates: "Validated methods shall be adopted to conduct regular integrity tests on the glove system of isolators. Tests shall usually be performed at least at the start and end of each batch or phased production. Additional tests shall be conducted during the phased production cycle if necessary." The biodeconta GISTOOL - 50 Tester fully meets this regulatory requirement — it strictly complies with GMP standards and Annex E.5 of ISO 14644 - 7, adopts the pressure decay method for accurate testing, supports customized flange sizes to fit isolator interfaces, features a built - in air pump for independent operation, and the printer equipped with the standalone version can directly store test data to meet the regulatory requirements for record traceability. This equipment provides a validated testing solution for the integrity of isolator gloves, helping microbiology laboratories implement sterile control and biosafety standards.

I. Installation Qualification (IQ): Verify the Basic Consistency of Validation

Documentation and Equipment Verification

Verify that the equipment, accessories, and technical documents are complete and matched in accordance with the Equipment Configuration List; check the calibration report (which must be valid and from a compliant institution), and sign the IQ Confirmation Appendix upon confirmation of no discrepancies.

Equipment Function Verification

Explain the functions of the equipment buttons and interfaces, start the equipment to enter the interface, click the "biodeconta" icon to access core interfaces (such as test parameters and historical data), and confirm that the information is clear, switching is smooth, and all button functions are normal.

Training and Sign - off

Complete the basic operation training. After the customer representative masters the operations, they shall sign the Appendix 1 - Pre - Test Confirmation Form to proceed to the next stage.

II. Operational Qualification (OQ): Validate Functional Compliance

Functional Training and Verification

Adopt the "explanation + demonstration + hands - on operation" mode to train on core functions including account management, parameter setting, glove testing, data/log management, and alarm handling, and verify the stable operation of all functions.

Confirmation and Sign - off

After the customer confirms that all functions are normal, they shall sign the OQ Confirmation Appendix jointly with our staff.

III. Performance Qualification (PQ): Validate Performance in Actual Use

On - site Measurement Preparation

Install the equipment on the isolator to ensure compliant sealing. Start the measurement after the equipment preheats and reaches stable operation.

Scenario - based Measurement

1. No Aperture (Normal Gloves): Conduct 3 repeated measurements with data fluctuation ≤ ±5%;
2. 300μm Aperture (Damaged Gloves): Conduct 3 repeated measurements to ensure accurate identification of abnormalities.

Threshold Value and Judgment Criteria

Calculate the threshold value using the formula: Threshold Value = (Average Value of No - Aperture Measurements + Average Value of 300μm Aperture Measurements) / 2. Subsequent judgments shall be based on this threshold: values below the threshold indicate leakage, while those above indicate normal conditions.

Report and Sign - off

Issue the Equipment Performance Confirmation Report. Both parties shall sign and file it, which shall serve as the basis for the official commissioning of the equipment.