MORE
Create an intelligent, safe and clean environment MORE
MORE
MORE
MORE
GISTOOL-50 Glove Integrity Testing System
GISTOOL-100 Glove Integrity Testing System

Integrity Testing

Biodeconta provides a complete integrity testing ecosystem for sterile manufacturing environments. Our GISTOOL series delivers precise, repeatable leak detection for both isolator gloves and Rapid Transfer Ports (RTP) using the pressure decay method, fully compliant with ISO 14644-7 and EU GMP Annex 1.
Each unit features a high-performance battery and air pump for cable-free operation in any cleanroom setting, with custom flange adapters for all major isolator brands. Our GTM software provides full lifecycle management of isolator gloves — tracking usage history, brand, replacement schedules, and test results — ensuring complete data traceability and audit-ready compliance.

GISTOOL-50 Glove Integrity Testing System

Portable glove integrity tester with 7-inch touchscreen and patented quick-release flange. Leak detection down to 200 μm (100 μm optional), ±0.2% accuracy. Supports standalone and wireless group control. Replaceable lithium battery, 4+ hours runtime. 21 CFR Part 11 compliant.

MORE

GISTOOL-100 Glove Integrity Testing System

Advanced model with 100 μm leak detection as standard. Adds optional LoRa long-range communication and built-in filtration. More compact at 1.6 kg. Same quick-release flange, RFID networking, and 21 CFR Part 11 compliance. Ideal for facilities requiring the highest detection sensitivity.

MORE

VHP Generators

HIVE Hornet S1.2

The HIVE Hornet S1.2 is a modular H2O2 vapor generator built on a distributed peer architecture — every unit operates as an independent master with no single point of failure. Units connect wirelessly via Siemens PLC, scaling from 150 m³ to over 1,200 m³ with up to 8 followers. Built-in 385 CFM airflow eliminates the need for external fans, and open solution compatibility (any ≥30% H2O2) removes vendor lock-in. Achieves 6-log kill at near-ambient outlet temperatures.
Bio Decontamination Service
Biodeconta provides turnkey hydrogen peroxide vapor decontamination services for facilities that require professional execution without equipment investment. Our certified team manages the full cycle: on-site inspection, solution design, service implementation, and post-decontamination verification reporting — all performed to GMP and biosafety standards.
MORE
Bio Decontamination Service
Isolator CSM Gloves
Biological Indicator

Isolator Gloves & Accessories

Biodeconta offers a complete isolator glove system — Long Gloves (L Series), Sleeves (F Series), and Short Gloves (S Series) — manufactured using our proprietary One-Piece Die Casting process. Unlike traditional dipped gloves, each glove is injection-mold

Isolator CSM Gloves

Hypalon/CSM

Available in six materials — CSM, BUTYL, EPDM, Neoprene, Nitrile, and IIR/FKM — to match your specific chemical resistance, temperature, and compliance requirements. All gloves are individually vacuum packaged and conform to EU Regulation 2016/425, EN ISO 21420, EN 388, and EN ISO 374-1.
MORE

Biological Indicator

BDBI-V6

Designed specifically for monitoring vaporized hydrogen peroxide (VHP) biodecontamination processes, it accurately verifies disinfection effectiveness in closed spaces and environments, upholding the sterile safety barrier.
High bioburden ensures monitoring accuracy;Individual packaging enables easy use and prevents contamination;Clearly defines the disinfection challenge level;Medical-grade stainless steel discs + Tyvek packaging: compatible with hydrogen peroxide penetration while ensuring protection.
MORE

Case Study

Driving Compliance and Quality in Aseptic Manufacturing: ISO 14644-7 Positive Pressure Glove Testing Series Part 3: Establishing a Detection Limit PQ Validation Protocol

In Part 1 of this series, we analyzed the technical rationale behind ISO 14644-7:2004 Annex E.5.3, focusing on the relationship between test pressure, sensor accuracy, and detection capability. In Part 2, we demonstrated why rigid standard leak holes are the appropriate PQ validation tool and presented real-world test data showing how stabilization time and test duration affect pressure decay across different hole sizes.

2026-04-14
MORE

News

Online glove integrity testing: the new industry standard and paradigm shift for pharmaceutical cleanroom glove integrity testting

Glove integrity is a primary control point for aseptic processing: isolator and RABS gloves form the physical barrier protecting sterile product from contamination. Recent regulatory updates — notably EMA Annex 1 (revised 2023) — and increasing inspection emphasis on data integrity mean manufacturers must reassess legacy approaches. Industry surveys and vendor case studies report test-cycle time reductions from several hours to under 10 minutes per glove when using online systems, enabling more frequent checks without production loss (see regulatory and business sections below for sources).

2026-01-15
MORE
Contact
Email：service@biodeconta.com
Address：220 Brew Street. Suit 301, Port Moody