KHT TA-30 Pharmaceutical Texture Analyzer Software — TPA, Reporting & 21 CFR Part 11

The KHT Texture Suite is the pharmaceutical texture analyzer software that ships with every TA-30. It delivers the three capabilities a regulated pharmaceutical QC lab cannot work without: a pre-loaded 30+ method library referencing USP <1217>, EP 2.9.8, JP 6.09, USP <1724>, ASTM D903, and 21 CFR Part 211; automatic two-cycle TPA analysis with calculation of seven classical parameters; and a complete 21 CFR Part 11 compliance stack.

Software is included at no additional license cost with every TA-30. Updates are free for the life of the instrument, and all compliance features are standard — there is no paid 'advanced edition.'

Software Overview: Dashboard, Method Library & Live Curve View

The KHT Texture Suite runs on Windows 10 and Windows 11 and connects to the TA-30 via USB. First-launch setup creates a local database (SQL Server LocalDB) that stores every method, result, user, and audit entry in a single consolidated, tamper-evident file with automatic backup to a user-specified network location.

The Dashboard is the primary operator screen, showing the currently loaded method, load cell identity and verification status, last calibration date, a live force-displacement preview window, and quick-access buttons for Start, Abort, Save, and Sign. For a QC analyst running routine batch-release tests, the dashboard eliminates setup overhead.

Study mode groups multiple batches or formulations into a single analysis unit with automatic statistical comparison, outlier detection, and multi-batch trend reporting — directly usable for formulation screening, stability studies, and QC trending.

TPA Analysis Module: Hardness, Cohesiveness, Springiness, Adhesiveness

Texture Profile Analysis (TPA) is the gold-standard multi-parameter characterization for pharmaceutical gels, hydrogels, soft chewable dosage forms, suppositories, and semi-solid formulations. The TA-30 runs full two-cycle TPA directly from a pre-loaded method — no post-processing, no manual calculation, no external data analysis required.

TPA parameters export directly into CSV, PDF, and XLSX batch reports alongside the full force-displacement curves. For formulation-screening studies, the automatic TPA output reduces what was historically a hand-calculation exercise to a single button click — with full 21 CFR Part 11 audit-trail coverage on every calculation.

• Hardness: peak force during the first compression cycle (N)
• Cohesiveness: ratio of positive-work area under the second compression cycle to the first (dimensionless)
• Springiness: ratio of second-cycle contact distance to first-cycle contact distance (dimensionless or mm)
• Chewiness: hardness × cohesiveness × springiness (for solid dosage forms, mJ)
• Gumminess: hardness × cohesiveness (for semi-solid dosage forms, N)
• Adhesiveness: negative work area after the first compression cycle (N·mm)
• Resilience: ratio of upstroke-area to downstroke-area within the first cycle (dimensionless)

USP & EP Method Templates (Pre-loaded, One-Click Run)

The KHT Texture Suite ships with 30+ pre-loaded methods, each referencing its originating standard. Methods are version-controlled: when an administrator publishes a new revision, the older version is archived and remains available for historical-data reanalysis.

21 CFR Part 11 Audit Trail, E-Signature & Data Integrity

21 CFR Part 11 compliance is the single feature most often cited by FDA-regulated pharmaceutical QC labs as a mandatory procurement requirement — and the feature most often sold as a paid add-on by competing platforms. The KHT Texture Suite ships with a complete Part 11 stack standard.

The audit trail logs every data-affecting action with user identity, timestamp at one-second resolution, action type, and the before/after value for any parameter change. It cannot be disabled, edited, or deleted by any user tier, including Administrator. Electronic signatures are tied to authenticated user accounts with cryptographic binding; two-factor authentication is supported via TOTP.

SOP lock-down mode prevents modification of method parameters during QC runs. Once an SOP is published by Administrator, Operators can execute the method but cannot change trigger force, speed, or any parameter. Tamper-evident data integrity is enforced through cryptographic checksums on every data record.

• Operator: execute methods, view own data, sign as Operator
• Reviewer: review and approve results from all Operators, sign as Reviewer
• Administrator: user management, method publication, system configuration
• QA: audit trail read access, SOP approval, compliance reporting

Export Formats, LIMS Integration & Multi-User Access

Export formats supported for individual results, batch statistical reports, and study-level trend reports: CSV for raw data, PDF for signed inspection-ready reports, JSON for structured data exchange, and XLSX for formatted worksheet output. Every export includes a signature panel and an audit-trail extract covering the exported records.

LIMS integration is provided via REST API with OAuth 2.0 authentication. LIMS and ELN platforms can pull results, push method parameters, retrieve audit records, and query study metadata programmatically. API documentation and sample client code for LabWare, STARLIMS, Sample Manager, and Benchling are included with every installation.

Multi-user access supports unlimited user accounts at no per-seat licensing cost. User accounts can be integrated with Active Directory for single-sign-on. Software updates are free for the life of the instrument, distributed with a validation-impact assessment document so QA can determine whether site-level re-validation is required.