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Instrumented 16-station single rotary tablet press for R&D formulation profiling, Heckel plot analysis, and pilot batch tableting.
Up to 50,000 tablets/hour (16 Stations, B & D interchangeable turret)
The STP-16 Single Rotary R&D Tablet Press is a fully instrumented compression system designed for formulation laboratories and pilot manufacturing plants. Equipped with high-precision piezoelectric force transducers on upper, lower, and pre-compression stations, the STP-16 measures punch displacement and compression force curves with microsecond temporal resolution.
| Number of Stations | 16 (B-Tooling) or 8 (D-Tooling)Source: SAMPLE datasheet — replace with approved datasheet |
|---|---|
| Max Compression Force | 80 kN Main / 15 kN Pre-compressionSource: SAMPLE datasheet — replace with approved datasheet |
| Turret Speed | 5 to 60 RPMSource: SAMPLE datasheet — replace with approved datasheet |
| Max tablet diameter | 25 (D tooling) mmSource: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L stainless steelSource: SAMPLE datasheet — replace with approved datasheet |
|---|---|
| Contact surface finish | ≤ 0.8, mechanically polished µm RaSource: SAMPLE datasheet — replace with approved datasheet |
| Non-contact structure | AISI 304, bead-blasted satin finishSource: SAMPLE datasheet — replace with approved datasheet |
| Elastomers | Silicone / EPDM to FDA 21 CFR 177.2600 and USP Class VISource: SAMPLE datasheet — replace with approved datasheet |
| Dust extraction | 150 m³/h at 15 kPa, connection DN 50Source: SAMPLE datasheet — replace with approved datasheet |
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| Supply voltage | 415 V ±10%, 3-phase + N + PE, 50 Hz (60 Hz option)Source: SAMPLE datasheet — replace with approved datasheet |
| Compressed air | 6 bar, dry and oil-free to ISO 8573-1 Class 2:4:1Source: SAMPLE datasheet — replace with approved datasheet |
| Control system | PLC with 10-inch colour HMI, recipe management and audit trailSource: SAMPLE datasheet — replace with approved datasheet |
| Weight | Approx. 1,200 kgSource: SAMPLE datasheet — replace with approved datasheet |
|---|---|
| Overall dimensions (L × W × H) | 1,300 × 1,150 × 1,900 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
| Service clearance | 1,000 mm on operator and maintenance sidesSource: SAMPLE datasheet — replace with approved datasheet |
| Noise level | < 78 dB(A) at 1 mSource: SAMPLE datasheet — replace with approved datasheet |
* Specifications may vary by model. Contact us for exact configuration.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Evidence: ISO 9001:2015 Quality Management System Certificate (PDF · 2 KB)Manufacturer self-declaration that the machine meets the essential health and safety requirements of the Machinery Directive, supported by a technical file and risk assessment to EN ISO 12100.
Evidence: EC Declaration of Conformity Template (Machinery Directive 2006/42/EC) (PDF · 2 KB)World Health Organization guidance on good manufacturing practice, widely used as the reference for export markets and WHO prequalification.
US regulation setting the controls under which electronic records and signatures are considered trustworthy and equivalent to paper records.
Evidence: Computerised System Validation & 21 CFR Part 11 Assessment Template (on request)Industry guidance for a risk-based approach to validating GxP computerised systems, used to scope the CSV deliverables supplied with the machine.
All configurations
Confirms that the STP-16 design, as specified, meets the user requirement specification before manufacture begins.
GMP configurations
Documents that the machine is installed to drawing, connected to the specified utilities and calibrated.
GMP configurations
Challenges the machine across its operating ranges, alarms and interlocks to show it performs as specified.
Customer-executed; product-specific acceptance criteria
Executed by the customer with our support: three consecutive batches meeting weight, hardness, friability and content uniformity limits.
All configurations; customer witnessing optional
Witnessed at our works before dispatch, so defects are corrected where the parts, tools and engineers are.
All configurations
Repeats the critical FAT checks at the customer site after installation and utility connection.
Machines with the PLC/HMI control package
Validation of the PLC/HMI control system to GAMP 5, including the 21 CFR Part 11 controls for electronic records.
| Model | StandardSTP-16 Standard | STP-16 Plus | STP-16 Containment |
|---|---|---|---|
| Output | Up to 50,000 tablets/hour (16 Stations, B & D interchangeable turret) | Up to 50,000 tablets/hour (16 Stations, B & D interchangeable turret) | Up to 50,000 tablets/hour (16 Stations, B & D interchangeable turret); approx. 15% lower under wash-in-place containment |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with automatic weight control, force-based rejection and tablet sampling | PLC with containment interlocks and WIP sequence |
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| Notes | Not specified | Not specified | For potent compounds; containment is verified by surrogate monitoring at SAT. |
| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
|---|---|---|---|---|---|
| Upper punch, B tooling | GP-TP-PNCH-STP16-01 | Tooling | 10% of station count | Per wear inspection | 6-8 weeks |
| Die, B tooling | GP-TP-DIE-STP16-02 | Tooling | 10% of station count | Per wear inspection | 6-8 weeks |
| Feeder paddle set | GP-TP-FPAD-STP16-03 | Wear part | 1 set | 12 months | 4 weeks |
| Punch dust cup kit | GP-TP-DCUP-STP16-04 | Wear part | 1 kit | 6 months | 3 weeks |
| Compression roller bearing | GP-TP-CRBR-STP16-05 | Wear part | 2 nos | 10,000 h | 2 weeks |
| Compression force load cell | GP-TP-LCEL-STP16-06 | Electrical | 1 no | On failure | 6 weeks |
Models, typical specification, utilities and materials of construction for the tablet press range. Sample content for staging; replace with the approved controlled document before go-live.
Front elevation and plan view with overall dimensions, service clearances and the utility connection schedule. Sample content for staging; replace with the approved controlled document before go-live.
Safety, installation, operation, cleaning, preventive maintenance and troubleshooting for the tablet press range. Sample content for staging; replace with the approved controlled document before go-live.
Protocol structure, prerequisites, test case tables and acceptance criteria for installation and operational qualification. Sample content for staging; replace with the approved controlled document before go-live.
Document review, mechanical, electrical, functional and performance checks witnessed at our works before dispatch. Sample content for staging; replace with the approved controlled document before go-live.
Installation verification, utility connection, re-test of critical FAT items and production trial at the customer site. Sample content for staging; replace with the approved controlled document before go-live.
GAMP 5 categorisation, 21 CFR Part 11 controls checklist, audit trail review and user access matrix for PLC/HMI control systems. Sample content for staging; replace with the approved controlled document before go-live.
Template declaration issued per machine serial number for CE-marked supply, listing directives and harmonised standards applied. Sample content for staging; replace with the approved controlled document before go-live.
Overview of the full range: capsule filling, tablet compression, blister packing, granulation, coating, washing, liquid filling and utilities. Sample content for staging; replace with the approved controlled document before go-live.
Checklist for DQ, IQ, OQ and PQ of solid oral dosage equipment, including surface finish, calibration and cleaning checks. Sample content for staging; replace with the approved controlled document before go-live.
Guide to electronic records, electronic signatures, audit trails and access control on machine control systems. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
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