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 hardness, cohesiveness, springiness, chewiness, gumminess, adhesiveness, and resilience; and a complete 21 CFR Part 11 compliance stack covering audit trail, e-signature, role-based permissions, SOP lock-down, and tamper-evident data storage. 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 rather than sold as a paid "advanced edition." This page documents every module in detail.
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.
Dashboard is the primary operator screen. It shows the currently loaded method, the current load cell identity and verification status, the last calibration date, a live force-displacement preview window, and quick-access buttons for Start, Abort, Save, and Sign. For a QC analyst running a routine batch-release test, the dashboard eliminates the setup overhead: the instrument arrives at work with the validated method already selected and the IQ/OQ/PQ-verified calibration file loaded.
Method library contains 30+ pre-loaded pharmaceutical methods organized by dosage form category (solid oral, semi-solid, transdermal, injectable, microneedle, packaging). Each method stores probe geometry, test speed, trigger force, target distance or rupture criterion, post-test analysis specification (peak, area, TPA, etc.), output metric definitions, and the originating compendial or regulatory standard. Methods are version-controlled: when an administrator publishes a new revision, the older version is archived rather than deleted and remains available for historical-data reanalysis.
Live curve view shows the force-displacement trace in real time as the test runs, with programmable cursors for peak-force identification and region-of-interest statistical analysis. Analysts can flag anomalous tests immediately without waiting for post-run analysis.
Study mode groups multiple batches or multiple 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. See the TPA pharmaceutical analysis guide for a full interpretation walkthrough.
The TPA module automatically calculates the seven classical TPA parameters from the two compression cycles:
- 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)
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.
USP & EP Method Templates (Pre-loaded, One-Click Run)
The KHT Texture Suite ships with 30+ pre-loaded methods, each referencing its originating standard. The pre-loaded pharmacopoeia methods cover:
| Method | Standard | Probe | Typical parameters |
|---|---|---|---|
| Tablet breaking force | USP <1217>, EP 2.9.8, JP 6.09 | 75 mm parallel plate | 1–2 mm/s, trigger 0.1N |
| Tablet friability correlation | USP <1217> (correlative) | 36 mm flat disc | 1 mm/s, multi-cycle |
| Capsule rupture | USP <1> (correlative) | 2 mm spherical | 1 mm/s, trigger 0.05N |
| Softgel capsule puncture | USP <1> (correlative) | 5 mm spherical | 0.5 mm/s |
| Gelatin Bloom strength | USP <1>, BP, GB13731 | 12.7 mm Bloom plunger | 0.5 mm/s to 4 mm depth |
| Gel spreadability | USP <1724> | Cone-and-plate | 1 mm/s |
| Ointment back-extrusion | USP <1724> | 25 mm back-extrusion rig | 2 mm/s |
| Suppository penetration | USP <1> (correlative) | 4 mm cylindrical | 1 mm/s |
| BP alginate raft strength | BP | Raft cell + wire mesh | 0.5 mm/s |
| Transdermal patch 180° peel | USP <1724>, ASTM D903 | 180° peel jig | 5 mm/s |
| Transdermal patch 90° peel | USP <1724>, ASTM D1876 | 90° peel fixture | 5 mm/s |
| Film tensile strength | ASTM D882 | Film grips | 10 mm/s |
| Syringe plunger glide force | ISO 7886, ISO 11608 | Glide rig | 100 mm/min |
| Auto-injector activation | ISO 11608 | Activation fixture | 5 mm/s |
| Needle insertion force | ISO 11608 | Needle holder | 1 mm/s |
| Blister peel | USP <661>, USP <1207> | Blister peel rig | 5 mm/s |
| Foil puncture | USP <661> | Foil plate + puncture probe | 1 mm/s |
| Child-resistant cap torque | USP <661> | Torque fixture | N/A (torque mode) |
| Microneedle array fracture | No dedicated standard | 6 mm flat cylinder | 0.5 mm/s |
| Mucoadhesion peel | USP <1724> | Tissue holder + 10 mm probe | 0.5 mm/s |
| TPA analysis (generic) | Internal | 36 mm flat disc | 1 mm/s, 2 cycles |
Every method is locked against parameter modification by users below the Administrator tier. When a method requires revision, the Administrator publishes a new version; the older version is archived and remains available for historical-data reanalysis. See the USP 1217 tablet hardness standard guide for the full USP <1217> method walkthrough.
21 CFR Part 11 Audit Trail, E-Signature & Data Integrity Features
21 CFR Part 11 compliance is the single feature most often cited by FDA-regulated pharmaceutical QC labs as a mandatory procurement requirement — and also 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. See the 21 CFR Part 11 compliance guide for the full regulation walkthrough.
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. The audit trail cannot be disabled, edited, or deleted by any user tier, including Administrator. Audit export is available in FDA-inspection PDF format and in structured JSON for LIMS ingestion.
Electronic signatures are tied to authenticated user accounts with cryptographic binding between the signer's credentials and the signed record. Two-factor authentication is supported via TOTP. Signature meaning (Reviewer approval, QA release, Operator attestation) is recorded alongside the signature per 21 CFR Part 11 §11.50.
Role-based user permissions run in four tiers:
- 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
Permissions are granular at the method level, so some methods can be locked to specific user pairs (for example, a stability-study method locked to the two validated study analysts).
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. This satisfies the GMP requirement for consistent batch-to-batch methodology.
Tamper-evident data integrity is enforced through cryptographic checksums on every data record. Any attempt to modify a stored result — even by direct database access — is detected on next read and flagged in the audit report.
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 data records in the export.
LIMS integration is provided via a 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 common LIMS platforms (LabWare, STARLIMS, Sample Manager, 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 in corporate environments. Session management enforces automatic logout after configurable inactivity periods.
Software updates are free for the life of the instrument — including major version upgrades. Updates are distributed with a validation-impact assessment document that lets a QA team determine whether a site-level re-validation is required.
Reporting templates for per-sample PDF reports, per-batch statistical reports, and per-study trend reports are template-driven and customizable with site branding, logo, and standard header/footer content.
For a full product specification including software-hardware integration detail, see the texture analyzer for pharmaceutical product page.
Request a Quote for the KHT TA-30
The KHT Texture Suite ships standard with every TA-30 pharmaceutical texture analyzer — 30+ pre-loaded methods, automatic TPA analysis, complete 21 CFR Part 11 compliance, LIMS REST API, and unlimited user seats at no additional license cost. Software updates are free for the life of the instrument. Transparent public pricing for the complete TA-30 package sits in the $8,000–$13,000 range, with quote responses within 24 hours and engineering technical support within the 48-hour direct-support SLA. Contact KHT Instrument to configure your system.