Products

Glove Integrity Testing

GISTOOL Series — Precision Leak Detection for Isolator Gloves

Biodeconta's GISTOOL series delivers accurate, repeatable glove integrity testing for aseptic manufacturing and cleanroom environments. Using the pressure decay method in full compliance with ISO 14644-7 Annex E.5 and EU GMP Annex 1, the system detects isolator glove leaks down to 100 μm with ±0.2% F.S. sensor accuracy.

Every GISTOOL unit features a built-in air pump and replaceable lithium battery for fully cable-free operation — no external power or air supply needed. The patented quick-release flange supports tool-free adapter changeover with custom sizing for all major isolator brands. Wireless group control scales to unlimited connected devices across multiple workshops and facilities.

Paired with our GTM (Glove Test Management) software, the system provides full glove lifecycle tracking, audit trail, electronic signatures, and batch reporting — all 21 CFR Part 11 compliant and audit-ready.

HIVE Hornet S1.2 — Modular H₂O₂ Vapor Generator

The HIVE Hornet S1.2 is a hydrogen peroxide vapor generator built on a distributed peer architecture — every unit operates as an independent master with full decontamination capability and no single point of failure. Scale from 150 m³ to over 1,200 m³ by adding up to 8 followers wirelessly.

Built-in 385 CFM airflow eliminates the need for external fans. Near-ambient outlet temperature protects heat-sensitive materials. Open solution compatibility (any ≥30% H₂O₂) means no vendor lock-in on consumables. Achieves 6-log kill efficacy with real-time process monitoring via integrated Vaisala HPP272 sensor.

Three-module design: top control layer (touchscreen + WiFi), middle generation layer (flash evaporation + integrated fan dispersion), and bottom storage layer (sealed aluminum alloy). Powered by Siemens S7-1200 industrial PLC.

Isolator Gloves — L/F/S Series

Biodeconta offers a complete isolator glove system — Long Gloves (L Series), Sleeves (F Series), and Short Gloves (S Series) — manufactured using a proprietary one-piece die casting process for superior integrity and consistency compared to traditional dipped gloves.

Available in six materials to match your specific chemical resistance, temperature, and compliance requirements: CSM (Hypalon), BUTYL, EPDM, Neoprene, Nitrile, and IIR/FKM. Multiple sizes from 7" to 12", with round and oval port options in both front-mount and reverse-mount configurations.

All gloves are individually vacuum packaged and conform to EU Regulation 2016/425, EN ISO 21420, EN 388, and EN ISO 374-1.

Compatible with all major isolator brands. Custom flange sizing available to match your existing setup.

VHP Biological Indicators — BDBI-V6

Biodeconta Biological Indicators use Geobacillus stearothermophilus ATCC 12980 spores at 10⁶ CFU to verify hydrogen peroxide vapor decontamination cycles. Each indicator is individually packaged on a medical-grade stainless steel carrier to prevent external contamination.
D-value: 1.0–2.0 min (25°C, 600 ppm). Shelf life: 9 months.
Applications: VHP cycle validation in isolators, RABS, sterile material transfer equipment, cleanrooms, and laboratory environments.

Supporting Culture Medium — BDBIM02

Improved Tryptic Soy Broth (TSB) medium with built-in pH indicator for clear color-change readout. Results after 7 days of incubation. 3.5 mL per piece, shelf life 12 months.