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Reinraum-Test - und Validierungsinstrumente
Glove Integrität Tester
A portable positive-pressure glove integrity tester for recording stabilized pressure decay across one isolator or RABS glove-and-sleeve assembly through a matched port adapter.
- In-situ pressure-decay testing.
- Single glove-port workflow.
- Traceable curve and result capture.
Produkteinführung
This compact single-channel tester combines a controlled inflation path, pressure sensing, timing and curve display in one portable console. A dedicated round adapter seals against the selected isolator or RABS glove port while the installed glove and sleeve remain in place. The instrument raises the assembly to the configured test pressure, allows a defined stabilization period, isolates the air supply and records pressure change over the measurement interval. The resulting curve and numerical decay value can be compared with an established recipe for that glove material, size, port geometry and environmental condition. A displayed result is test evidence; it does not by itself certify the barrier or replace the site's approved integrity procedure and visual inspection.
Key Features
Color touch display presents inflation, stabilization and pressure-decay phases as one time-based curve for immediate review.
Four physical keys provide essential start, stop, navigation and confirmation control when touchscreen-only operation is undesirable.
Matched round port cover with a replaceable hygienic seal supports in-situ testing without removing the glove or sleeve from its working flange.
One regulated pneumatic path, one pressure sensor and a quick coupling simplify setup checks and help preserve repeatable test conditions.
Rechargeable battery base and integrated top handle support movement between glove ports without a permanently installed console.
Kunden Produktbedenken
Meaningful glove integrity testing depends on more than measuring a pressure drop: the port-cover seal, glove elasticity, temperature, stabilization interval, test pressure and acceptance threshold must all be controlled for the specific glove-and-sleeve assembly.
Leakage at the test-cover seal can be mistaken for a defect in the glove or sleeve.Use an adapter matched to the exact port geometry, inspect and clean the sealing ring, secure the cover uniformly and perform the specified setup leak check before testing the glove assembly.
Glove stretch and temperature change can create pressure drift even when no puncture is present.Apply the qualified inflation pressure and stabilization time, keep the glove position consistent and avoid handling or rapid environmental changes during the measurement phase.
One test recipe may be reused across different glove materials, sizes or sleeve lengths.Maintain separate recipes for each relevant assembly and establish the pressure, stabilization interval, test duration and allowable decay using intact and deliberately challenged samples.
Excessive test pressure can strain a glove while insufficient pressure reduces useful leak sensitivity.Limit inflation to the approved range for the installed assembly and use the regulated single pressure path rather than an uncontrolled external air connection.
Disinfectant or vaporized-agent exposure can affect seals, tubing and enclosure surfaces.Select compatible adapter and seal materials, follow the approved cleaning method and inspect the hose, quick coupling and sealing ring before each test sequence.
A pass indication can be treated as complete proof of barrier suitability without reviewing test conditions.Retain the pressure curve, recipe identity, port identification and timestamp, then evaluate them together with visual inspection and the approved glove-management requirements.
Typische Anwendungen
In-situ integrity checks of pharmaceutical isolator glove-and-sleeve assembliesRoutine glove-port testing on open or closed RABS installationsPre-use and post-operation checks defined by an aseptic processing programInvestigation after suspected glove contact, snagging or maintenance activityTest-recipe development for a new glove material, size or port geometry
Technische Parameter
The representative portable system below provides one regulated pressure-decay channel, one matched glove-port adapter and time-based result capture. Final pressure range, stabilization time, measurement duration, adapter diameter, seal material and recipe limits should be selected for the intended glove assembly and test procedure.
| Core Material | Powder-coated aluminum portable chassis with PC/ABS blue protective trim, stainless or engineering-polymer glove-port adapter, silicone sealing ring and clean pneumatic tubing |
|---|---|
| Panel Dicke | Typically 2.0-3.0 mm for the portable enclosure panels and protective trim sections |
| Effektive Breite | Approximately 280-360 mm across the main tester console, excluding the detached glove-port adapter |
| Maximale Länge | Approximately 650-900 mm for the complete arranged kit including the connected hose, adapter and one installed glove |
| Stahl facing Dicke | Typically 1.0-1.5 mm for stainless adapter covers, connector plates and protective hardware |
| Kerndichte | Approximately 2700 kg/m³ for the aluminum structural chassis sections |
| Thermische Leitfähigkeit | Approximately 160-205 W/(m·K) for the aluminum chassis alloy |
| Oberfläche Finish | Smooth warm-white and light-gray enclosure with cobalt-blue protective trim, dark touch display, charcoal keys, satin stainless fittings, blue pneumatic tube and a light-blue glove sample |
| Gemeinsamer Typ | Single regulated console outlet with one stainless quick coupling and blue pneumatic hose to one round glove-port test adapter with a replaceable compression seal |
| Customisierung | Verfügbar je nach beabsichtigter Anwendung und Betriebsumgebung. |
Verfügbare Optionen
Round and oval glove-port adapters in application-specific diametersStainless-steel or hygienic engineering-polymer adapter constructionSilicone or compatible elastomer replacement sealing-ring setsAlternative blue pneumatic-hose lengths and stainless quick couplingsRechargeable battery, charging cradle and protected transport caseBarcode or RFID port identification and configurable user accessUSB or network result export with recipe and audit-history management
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