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).

This article explains why glove integrity testing is moving from offline removal methods to in‑place online systems, and shows the operational, compliance and data-driven ROI arguments. You will find: a clear comparison of methods, regulatory requirements, a technology feature analysis, implementation guidance and recommended KPIs to measure success.

What Is Offline Glove Integrity Testing?

Offline glove integrity testing is the conventional approach to detecting glove leaks. Technicians remove isolator or RABS gloves from the production environment, mount them on dedicated equipment and run integrity tests. The full cycle typically includes:

• Complete disassembly of gloves from the production environment
• Transportation to testing equipment
• Sterilisation procedures before and after testing
• Reassembly and reinstallation
• Additional sterilisation to restore aseptic conditions

This process is labour‑intensive and time-consuming: typical offline cycles can take several hours per glove when including transport and sterilisation, which limits testing frequency and increases the risk of contamination during handling.

The Online Glove Integrity Testing Advantage

Online glove integrity testing performs leak detection in situ, with gloves remaining installed on isolators or RABS throughout the test. By testing the complete, installed system (including the glove‑to‑flange connection), online methods better reflect actual operating conditions and deliver a number of practical advantages:

• In‑Place Testing: No removal or reinstallation — the isolator glove remains in use during the test, eliminating handling risk.
• Short Test Time: Many online devices complete a validated pressure‑decay test in minutes rather than hours, enabling more frequent checks with minimal production impact.
• No Sterilisation Disruption: Because gloves stay mounted, there is no requirement for additional sterilisation cycles solely for testing purposes.
• Continuous or Frequent Monitoring: Low‑impact tests allow for scheduled checks at batch start/end and additional risk‑based intervals without excessive labour costs.
• True Operational Simulation: Online systems test the whole assembly (material, thickness, flange seal and glove interface), improving detection of failures such as pinholes, seam defects or flange leaks that offline tests can miss when gloves are tested off‑flange.

Practical considerations: glove material and thickness influence detectable hole diameter — a thinner polymer glove may allow detection of smaller pinholes than a thicker formulation under equivalent pressure decay sensitivity. For context, field data and vendor specifications commonly report online detection of pinholes and defects in the order of tens to a few hundred micrometres depending on method sensitivity and test parameters; explicit device detection limits should be verified from the manufacturer's datasheet during procurement.

Example scenario: an anonymised case study from a mid‑scale sterile facility showed that an online pressure‑decay test detected a micro‑leak around a flange (approx. 150 μm equivalent) that had not been identified during previous offline sample testing. The online detection prevented a potential contamination event and illustrated the advantage of testing the installed glove assembly under positive pressure conditions.

The subsequent sections compare methods quantitatively (test time, operator effort), examine regulatory expectations and present an ROI framework for switching from offline to online integrity testing.

FDA 21 CFR Part 11 Compliance: The Data Integrity Imperative

21 CFR Part 11 sets the US regulatory expectations for electronic records and electronic signatures in pharmaceutical manufacturing. For glove integrity testing this has concrete implications: test results must be recorded in a secure, tamper‑evident way with full audit trails, controlled user access and validated software. Online systems typically make compliance easier to demonstrate by providing:

Electronic record capabilities such as automated time‑stamped data logging, secure electronic signatures and immutable audit trails;

• Automated, time‑stamped data capture that reduces transcription errors
• Role‑based access and electronic signature functionality to support approval workflows
• Comprehensive audit trails recording who ran each test, when and with what result
• Validated software platforms and change control logs to demonstrate software lifecycle management
• Data integrity controls that reduce the risk of unauthorised modification

By contrast, traditional offline approaches that rely on manual recording and paper logs introduce higher audit risk, greater potential for transcription errors and longer, less defensible review cycles during inspections.

EMA Annex 1 Revision: Raising the Bar for Aseptic Manufacturing

The European Medicines Agency (EMA) revised Annex 1 to Good Manufacturing Practice in 2023; the update places greater emphasis on demonstrable contamination control and on defined integrity verification for barrier systems. Annex 1 specifically reinforces a testing frequency that, at minimum, requires verification at the start and end of a production batch or campaign and at the beginning and end of a manual aseptic session for small‑batch processes. Where applicable, sites must adopt a risk‑based approach to determine any additional checks.

This change materially increases the number of required tests per year for many operations. For example, a facility running 50 batches annually that previously performed weekly routine tests may see testing frequency increase by an order of magnitude depending on batch structure—magnifying the operational burden of offline methods and favouring rapid, in‑place online testing.

Quality by Design (QbD): Annex 1 also requires that equipment and test methods be "demonstrated to be suitable for the task and criticality." Online glove testing supports QbD by testing the complete installed assembly under operational conditions, producing reproducible results and enabling faster test cycles that align with the regulation's intent.

ISO 14644‑7 Annex E.5: The Technical Standard

ISO 14644‑7 provides technical guidance for testing cleanroom items, including gloves and glove ports. Annex E.5 describes approaches to localised leak testing and informs method selection and acceptance criteria. Pressure‑decay based methods, commonly used in modern online systems, are explicitly referenced in industry practice for their sensitivity and repeatability when properly qualified.

Claims of specific detection limits (for example, "detects defects as small as 100 μm") depend on the test method, device precision and test conditions; such numeric performance claims must be verified against the device's validation data and ISO‑recommended test parameters. During procurement and validation, sites should record and accept device‑specific detection limits as part of the acceptance criteria and PQ protocol.

Practical implications and compliance checklist

• Regulatory requirements (Part 11, Annex 1) increase the need for secure electronic records and higher test frequency — plan systems that natively support both.
• Define acceptance criteria in the protocol (linked to ISO guidance and risk assessment) and document how the chosen pressure‑decay method meets those criteria.
• Quantify annual test volumes during the qualification phase to model labour and time impacts of offline vs online approaches.
• Ensure software used for testing is validated, supports audit trails and electronic signatures, and integrates with your quality systems to demonstrate compliance during inspection.

In summary, converging regulatory expectations for data integrity, specific testing intervals and equipment suitability create a strong compliance argument for online glove integrity testing. The following sections quantify the operational impact and show how to capture a robust ROI while meeting acceptance criteria required by regulators and standards such as ISO 14644‑7.

Operational Efficiency and Throughput

The pharmaceutical sector must maximise throughput while preserving sterility. Online glove integrity testing produces measurable efficiency gains versus offline methods by reducing per‑test cycle time, lowering process interruptions and enabling higher test frequency without line loss.

Reduced testing time: Offline workflows — glove removal, mounting on test rigs, sterilisation cycles and reinstallation — commonly take several hours per glove when full preparations are included. By contrast, validated online pressure‑decay tests typically complete in minutes, converting a multi‑hour operation into a short, repeatable check and allowing many more tests to be executed within the same production window.

Minimised production disruption: Because gloves remain mounted, online systems let you schedule tests at batch transitions or during planned pauses, preserving uptime and reducing changeover duration. This lowers the indirect cost of testing and improves line availability.

Higher testing frequency without penalty: Faster, low‑impact tests support Annex 1‑aligned frequency (start/end of batch) plus risk‑based additions with minimal operational cost — improving contamination control and providing stronger, data‑driven confidence in product protection.

Labour Cost Reduction

Labour is a large and recurring cost for sterile manufacturing. Switching from offline to online testing reduces hands‑on technician time and concentrates supervisory activities.

Offline systems: Require multiple skilled interventions per test (disassembly, transport, sterile handling, test setup, post‑test sterilisation). These steps multiply technician hours and increase glove handling, which in turn can raise the probability of glove damage.

Online systems: Use automated test sequences, centralised control and wireless group management. A single operator can supervise multiple isolators or RABS units via group control dashboards, lowering labour per test and enabling centralised scheduling and review.

Risk Mitigation and Quality Assurance

Online testing strengthens quality assurance through more representative system checks and fewer opportunities for contamination and damage.

Glove‑flange connection testing: Online testers evaluate the entire installed assembly — glove material, thickness, seam integrity and the glove‑to‑flange interface — identifying failure modes (for example flange leaks or seam defects) that offline separated tests can miss.

Reduced contamination risk: Eliminating glove removal/reinstallation events preserves the aseptic barrier and reduces the number of sterility interventions, lowering contamination risk and the likelihood of batch loss related to handling‑induced damage.

True operational validation: Testing under the actual pressure and configuration used during production gives results that map directly to real‑world performance, simplifying acceptance criteria justification and regulatory reporting.

Practical ROI example and KPIs to track

• Estimated time saving: conservatively, replace a 3‑hour offline cycle with a 10‑minute online test (net saving ≈170 minutes per test).
• Labour saving: if a technician costs £40/hour, a single converted test saves ≈£113 in direct labour (170 minutes ≈2.83 hours).
• Annualised impact: at 1,000 tests/year this equates to ≈2,830 technician hours and ≈£113,000 saved in direct labour — before accounting for reduced sterilisation consumables and fewer production interruptions.
• Recommended KPIs post‑implementation: tests per batch, tests per operator per day, technician hours per test, false‑positive rate, detection rate (pinholes detected), time‑to‑release and annualised cost savings.

These numbers are illustrative; sites should run a site‑specific cost model using local labour rates, batch structure and expected test frequency. The next section compares technical capabilities and method precision to help translate these operational benefits into validated acceptance criteria and procurement specifications.

Data Integrity and Compliance

Offline Systems:

• Limited electronic data capture — often reliant on paper records or manual entry
• Manual transcription increases the risk of human error and data integrity issues
• Basic, often ad hoc reporting that complicates trend analysis
• Challenging integration with Manufacturing Execution Systems (MES) and Quality platforms

Online Systems:

• Automated, timestamped electronic data capture that reduces transcription errors
• Software frameworks designed to support 21 CFR Part 11 requirements (audit trail, electronic signatures)
• Comprehensive reporting and native integration options for enterprise quality management systems and MES
• Centralised device management and secure user access controls to simplify validation and inspection readiness

Testing Capability and Accuracy

Offline Systems:

• Typically test gloves off‑flange, so they do not evaluate the installed glove‑to‑flange interface
• Non‑operational configuration testing can miss system‑level failures
• Sequential testing only — limited ability to parallelise across many gloves

Online Systems:

• Complete system testing, including glove material, seam integrity and glove‑flange connection — testing reflects actual use conditions
• Designed to operate under production pressure regimes (positive pressure or user‑defined setpoints) to replicate in‑service conditions
• Scalable group control enables parallel tests across many isolators, subject to the chosen device’s networking capability
• Pressure‑decay and decay‑method variants are the most common approaches; device precision varies by manufacturer and instrument class (typical repeatability/precision commonly falls in the range 0.1–0.5% of full scale — confirm with vendor datasheets)
• Declared detection limits (for example tens to a few hundred micrometres) depend on test method, pressure differentials, test volume and environmental noise; these numeric claims should be validated and included in PQ acceptance criteria

Note on claims: specific performance numbers such as "0.2% accuracy", "detection of defects as small as 100 μm" or "support for 200+ simultaneous devices" are device‑specific. Always request vendor validation data and independent test reports and include those figures in the procurement and validation dossiers rather than relying on generic marketing claims.

Deployment and Scalability

Offline Systems:

• Centralised testing location with physical setup constraints
• Limited scalability — testing throughput increases only by adding more physical rigs and operators
• Sequential testing increases total elapsed time and complicates high‑frequency regimes

Online Systems:

• Distributed, at‑line deployment enables tests at each production line or isolator port
• Wireless networking and modular architectures support parallel testing and phased scale‑up
• Centralised dashboards allow fleet‑level monitoring, trending and remote review, improving operational oversight
• Modular expansion reduces upfront cost by permitting staged investments aligned with capacity growth

Failure Modes, False Positives and Mitigation

• False positives can arise from environmental pressure fluctuations, poor sealing at test collars, or incorrect test parameters — mitigate with environmental controls, repeated confirmation tests and clear SOPs.
• Regular calibration of pressure sensors and verification of test collar seals reduce measurement drift and maintain precision.
• Include acceptance criteria and repeat‑test rules in the test protocol (for example: confirm a suspect result with two repeat tests before initiating an investigation) to limit unnecessary investigations while preserving sensitivity.

Recommendation: include a concise comparison table in the final article summarising data integrity features, method precision ranges, detection capability caveats and scalability notes so procurement teams can compare offline and online options using consistent criteria. During procurement and validation, explicitly require vendor evidence for precision, pressure‑decay method performance, pressure drop sensitivity, and networked device limits to avoid post‑purchase surprises.

Validation and Qualification

Moving from offline to online glove integrity testing requires a structured qualification programme that aligns with cGMP expectations. A clear IQ/OQ/PQ plan removes ambiguity during inspection and speeds regulatory acceptance.

Installation Qualification (IQ): Verify correct equipment installation and configuration against vendor specifications. Typical IQ deliverables: installation checklist, wiring and network diagrams, device firmware/software versions, utilities verification (power, wireless coverage), and traceable component serial numbers.

Operational Qualification (OQ): Demonstrate that the system operates across its intended range. OQ activities should include functional tests for data capture, electronic signature workflows, alarm handling, communication with MES/QMS, and repeatability tests across representative pressure set points. Document test protocols, raw data and deviation handling.

Performance Qualification (PQ): Confirm consistent performance under actual production conditions. PQ should include worst‑case and normal operating scenarios, verification of detection limits (linking to acceptance criteria), repeatability across users and shifts, and integration of results into release workflows. Record pass/fail criteria, sample sizes and statistical justification for acceptance levels.

Recommended validation checklist items to include in protocols:

• Acceptance criteria for test results (e.g. pressure‑drop thresholds, allowable variance)
• Number of replicates for OQ and PQ and statistical rationale
• Environmental conditions during tests and controls for pressure/temperature noise
• Calibration procedure and schedule for pressure sensors
• Software validation evidence: IQ/OQ/PQ for the application, audit trail demonstration and Part 11 conformance artefacts
• Vendor‑provided documentation: functional specifications, FAT/SAT reports and traceability matrices

Typical timelines (indicative): IQ (1–2 weeks), OQ (2–4 weeks depending on test complexity), PQ (2–6 weeks to capture production variability). Timelines will vary with facility size, number of ports and scope of system integration.

Training and Change Management

Successful rollout depends on clear change management, stakeholder engagement and outcome‑focused training.

• Stakeholder mapping: identify QA, engineering, operations, IT and validation owners and define roles for decision‑making and acceptance.
• Pilot phase: run a controlled pilot (one isolator or production line) to gather real operational data, tune SOPs and finalise acceptance criteria before full deployment.
• Risk assessment: update site risk assessments to include new failure modes (network outages, software updates) and define mitigation actions.

Training curriculum suggestions and measurable outcomes:

• Module 1 — System overview and purpose: users should explain why online testing is used and where it fits into the site quality system.
• Module 2 — Test operation and SOPs: users must be able to execute a test, interpret pass/fail and initiate correct follow‑up actions (measured by observed competency checks).
• Module 3 — Data review and electronic signatures: users authorised to sign must demonstrate correct e‑sign procedures and report generation.
• Module 4 — Preventive maintenance and basic troubleshooting: operators should perform routine checks and escalate according to support procedures.
• Module 5 — Change control and security: IT and validation teams must be trained on patching, backup and restoration procedures for the test system.

Suggested training metrics: percentage of users certified, average time to competence (hours), number of supervised tests required to sign off, and post‑deployment error/incident rates. Include refresher training in the preventive maintenance schedule and when SOP or software changes occur.

Finally, document the change control package: updated SOPs, validation deliverables, training records, risk assessments and an implementation plan with milestones. Using a staged rollout with a pilot reduces operational risk, allows tuning of acceptance criteria and provides the data needed to demonstrate the system meets site requirements for ongoing use.

Market Adoption Accelerating

Adoption of online glove integrity testing is growing across new-build and retrofit projects as manufacturers prioritise compliance, throughput and contamination control. While independent, published market shares vary by region and supplier, consultation with industry analysts and vendor case studies consistently report accelerating deployment: early adopters in sterile manufacturing are moving from pilot projects to facility-wide rollouts to meet increased testing frequency and data integrity expectations.

• Regulatory pressure from FDA and EMA enforcement activities is encouraging sites to adopt systems that natively support audit trails and validated electronic records.
• Competitive pressure to maximise manufacturing efficiency drives investment in systems that reduce downtime and labour per test.
• Industry best practice is shifting toward preventative contamination control, with installed testing seen as superior for detecting system-level leaks versus off‑flange sampling.
• Technological maturity — improved pressure‑decay algorithms, wireless networking and centralised dashboards — makes system‑level deployments practical and cost‑effective.

Future Regulatory Direction

Regulatory agencies continue to emphasise contamination control and data integrity; expect progressively clearer guidance on testing frequency, acceptance criteria and electronic system requirements. Reasonable near‑term developments include:

• More prescriptive guidance on testing frequency and documented acceptance criteria to support risk‑based approaches.
• Enhanced expectations for electronic systems (Part 11 style controls): secure logging, access management and demonstrable validation artefacts.
• Greater inspector attention on barrier system integrity programmes during GMP inspections and dossier reviews.
• Gradual harmonisation of international standards, reducing regional variability in expectations.

Technology Evolution

Online glove testing platforms continue to evolve and converge with digital manufacturing trends:

• Integration with IoT and Industry 4.0 ecosystems for centralised device telemetry and fleet management across isolators and lines.
• Predictive analytics to estimate glove lifecycle, anticipate damage and schedule preventive replacement — reducing unexpected glove failures and unplanned stoppages.
• Enhanced wireless connectivity and hardened cybersecurity measures to protect test data, maintain Part 11 conformance and reduce network risk.
• Cloud‑based data aggregation and analytics to streamline trending, investigations and regulatory reporting.
• Machine learning and anomaly detection tools to surface subtle leak patterns and reduce false positives, improving test reliability and user confidence.

Practical note: when planning adoption, include IT and user‑representatives early to address data governance, network requirements and backup/restore strategies. This reduces rollout friction and ensures the system meets both operational and compliance requirements for isolator glove testing.

Frequency and Scheduling

An effective glove integrity testing programme balances regulatory minimums with a risk‑based approach tailored to your processes. At a minimum, align test scheduling with EMA Annex 1 guidance — verify glove integrity at the beginning and end of each production batch or campaign, and for small manual aseptic sessions at the start and finish of each session.

Risk‑based additions should include:

• Critical processes with a high contamination risk (e.g. terminally sterile products, high‑value biologics)
• Extended production campaigns where cumulative wear increases failure probability
• After maintenance, glove replacement or flange work that could affect seals
• When environmental monitoring trends indicate increased particulates or excursions
• When operators report unusual glove behaviour or suspected damage

Suggested frequency template (example — adapt to your site risk assessment):

• Batched production: test at batch start and end; if batch duration >24h, schedule interim checks every 8–24h depending on risk.
• Continuous/long campaigns: test at defined campaign milestones (e.g. every shift, or daily) with added checks after any intervention.
• Small manual sessions: test at session start/end as per Annex 1.

Documentation and Record‑Keeping

Robust documentation is essential for regulatory compliance and continuous improvement. Online systems simplify record keeping by generating electronic records, but sites must still define required record fields and retention rules.

• Minimum record fields: test ID, isolator/port ID, glove ID (if applicable), operator, timestamp, test method (pressure decay/decay method), setpoint and environmental conditions, raw data, calculated pressure drop/decay, pass/fail result and electronic signature.
• Explicit acceptance criteria and pass/fail decision rules must be documented and linked to the test protocol and site risk assessment.
• Investigation reports for failures should include root cause analysis, corrective actions, re‑test results and impact assessment on any affected batches.
• Trending and periodic review: maintain and review time‑series of results (e.g. monthly) to identify patterns in glove wear, leak incidence or degradation of sealing components.
• Integration: connect test results to deviation management and CAPA systems to ensure traceability of investigations and preventative measures.

Preventive Maintenance and Calibration

Maintaining test reliability requires a planned preventive maintenance (PPM) programme focused on instrumentation, test collars and software health.

• Regular calibration of pressure sensors and transducers — define intervals in the calibration plan (typical starting point: annual calibration, with interim verification checks; shorten interval if drift is observed or per vendor guidance).
• Validate and inspect test collars, sealing surfaces and gaskets on a scheduled basis; replace worn seals per the preventive maintenance schedule.
• Manage software updates and security patches under change control; validate any update that affects data capture, calculations or audit trails.
• Maintain battery and power‑redundancy procedures for wireless devices and ensure network resilience to avoid data loss during tests.
• Perform an annual system qualification review (review IQ/OQ/PQ evidence, revisit acceptance criteria and update risk assessments).

Acceptance Criteria, False Positives and Investigation Workflow

Define clear acceptance criteria in the PQ protocol and SOPs — include numeric thresholds (pressure drop per unit time, decay rates) supported by method validation. Because detection limits depend on glove material, thickness and test volume, acceptance criteria must be device‑specific and justified in the validation dossier.

• False positives: common causes include transient pressure fluctuations, poor collar seating or environmental noise. Mitigation: repeat the test immediately (recommended two confirmatory tests) before initiating a full investigation.
• Investigation workflow: initial confirmatory tests → environmental checks (pressure, airflow, recent interventions) → review historical trend data and operator actions → root cause analysis → corrective action and re‑test. Document every step in the deviation report.
• Results and reporting: capture final test results in the electronic record, link to any affected batch records and include a summary in periodic quality reviews.

KPIs and Continuous Improvement

Track a concise set of KPIs to measure programme effectiveness and demonstrate compliance:

• Number of tests per batch and per year
• Technician hours per test
• Pass/fail rate and detection rate (pinholes or leaks detected)
• False‑positive rate and confirmation test rate
• Time to investigation closure and time to batch release
• Calibration drift metrics and device uptime

Regularly review acceptance criteria against trending data and inspection findings, and update the test strategy as part of continuous improvement. Where appropriate, include pressure‑decay test parameter rationales (positive pressure setpoints, test duration, sensitivity) in the supporting documentation so that results are defensible during regulatory inspections.

Home

The pharmaceutical manufacturing sector is at an inflection point for glove integrity. Traditional offline methods — useful historically — increasingly fall short of contemporary regulatory expectations, operational demands and quality assurance needs. Online glove integrity testing offers a modern, auditable and operationally efficient alternative that aligns with current guidance and business objectives.

Key benefits that make online testing the industry preference:

• Superior regulatory compliance: native electronic records, audit trails and e‑signatures simplify demonstration of 21 CFR Part 11 conformance and help meet EMA Annex 1 expectations for documented verification.
• Enhanced product protection: testing the complete installed assembly under realistic pressure and use conditions improves detection of glove‑to‑flange leaks and material defects that can lead to contamination.
• Operational excellence: low‑impact tests reduce downtime, permit higher testing frequency and free technician time for higher‑value activities.
• Reduced risk: fewer glove handling cycles mean lower contamination and glove damage risk, with test results that map directly to operational performance.
• Economic advantage: lower total cost of ownership through reduced labour, fewer sterilisation cycles and decreased likelihood of batch loss.

Next steps — how to get started

• Perform a gap analysis: map your current glove testing programme, including test frequency, time per test and record processes, against Annex 1 and Part 11 requirements.
• Run a pilot: deploy an online tester on one isolator or line to collect real operational data, validate detection limits and confirm integration with your MES/QMS.
• Compile validation deliverables: prepare IQ/OQ/PQ protocols and acceptance criteria informed by device validation data and site risk assessment.
• Plan rollout and training: use a staged approach with stakeholder engagement (QA, ops, IT, validation) and measurable training outcomes for users.

For teams evaluating practical solutions, Biodeconta’s glove integrity tester is one example of a pressure‑decay based online device designed for isolators and RABS; it supports Part 11‑style data handling and is engineered for in‑place glove leak detection. For a demonstration, see Biodeconta’s YouTube channel: https://www.youtube.com/@Biodeconta

Adoption of online glove integrity testing is no longer optional for manufacturers seeking robust contamination control, reliable data and operational efficiency. The decision today is how quickly you implement a validated, scalable solution to protect product quality and patient safety.

Modern online glove integrity testing solutions combine wireless device management, validated software platforms and pressure‑decay methods to deliver repeatable, auditable tests for isolators and RABS. When specified and qualified correctly, these systems help sites meet the expectations of 21 CFR Part 11, EMA Annex 1 and ISO 14644‑7 while improving operational efficiency and reducing glove handling‑related risks.

Key capabilities to require in procurement and validation: clear device precision and pressure sensor calibration data, documented detection limits linked to glove material and thickness, support for positive pressure test regimes, Part 11‑style audit trails and e‑signatures, and networked group control for fleet‑level management.

Biodeconta’s glove integrity tester is an example of a pressure‑decay based online device engineered for isolator and RABS use. The system is designed to provide in‑place glove leak testing with centralised data capture, Part 11‑compatible records and modular deployment for scalable rollouts. For specification details, validation artefacts and a product demonstration, see Biodeconta’s YouTube channel: https://www.youtube.com/@Biodeconta

For manufacturers seeking a pilot or validation package, contact Biodeconta to request device datasheets (precision, detection limits in micrometres and simultaneous‑device support), a sample IQ/OQ/PQ pack and an ROI model tailored to your batch structure and labour rates.