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The TEU-H65 is a fully automatic rotary tablet press purpose-built for double-layer (bi-layer) pharmaceutical tablet production in strictly regulated cGMP manufacturing environments. Equipped with 65 B-type punch stations producing 280,800 tablets per hour, this machine delivers the optimal balance of high productivity and pharmaceutical-grade precision for medium to large-scale solid dosage operations. Every aspect of its design from the sealed compression cabin to the validated control system is engineered for full regulatory compliance.
This double-layer tablet press features independent dual force-feeding systems with vacuum dust extraction, real-time automatic weight control (AWC) with individual layer sampling, 100kN main compression, and a fully enclosed sanitary design with quick-disassembly product contact parts. The German PLC with 21 CFR Part 11 compliant controls provides multi-level security, electronic batch records, and comprehensive audit trails required by FDA, EMA, and international regulatory agencies.
Key Features
Full cGMP Compliance Design: Sealed compression cabin, sanitary SUS304/SUS316 contact surfaces, HEPA-filtered dust extraction, and fully documented IQ/OQ/PQ validation package.
Double-Layer Tablet Technology: Two independent filling and pre-compression stations produce perfectly bonded bi-layer tablets with clearly defined layer separation and zero cross-contamination risk.
21 CFR Part 11 Control System: German PLC with electronic signatures, multi-level password protection, secure data logging, and full audit trail capability for regulatory inspections.
Precision Weight Control: Real-time AWC system with independent first-layer sampling capability maintains both layers within pharmacopoeia weight tolerances throughout production runs.
Rapid Sanitary Changeover: All product contact parts feature tool-free quick-disassembly for efficient cleaning validation between products and formulations.
Single-Layer Flexibility: Easily switchable to single-layer mode via HMI for maximum equipment utilization across your product portfolio.
Technical Specifications
Parameter
TEU-H65
Number of punches
65
Punch type
B
Punch shaft diameter (mm)
19
Die diameter (mm)
30.16
Die height (mm)
22.22
Main pressure (kN)
100
Pre-pressure (kN)
100
Turret speed (rpm)
72
Capacity (pcs/h)
280,800
Max. tablet diameter (mm)
16
Max. irregular-shaped length (mm)
19
Max. tablet thickness (mm)
8.5
Max. filling depth (mm)
16
Voltage
380V/3P 50Hz (customizable)
Main motor power
11 kW
Pitch circle diameter
720 mm
Machine dimension
1,300 * 1,300 * 2,125 mm
Operation cabinet dimension
704 * 600 * 1,300 mm
Net weight
5,000 kg
Frequently Asked Questions
Q1: What makes this machine specifically GMP-compliant?
A: The TEU-H65 is designed from the ground up for cGMP facilities: fully enclosed sealed compression cabin with HEPA extraction, SUS304/SUS316 sanitary product contact surfaces with surface finish certification, tool-free quick-disassembly for validated cleaning, complete IQ/OQ/PQ documentation, and 21 CFR Part 11 compliant controls with full audit trail capability.
Q2: Can this machine be used in an EU GMP Annex 1 or FDA sterile manufacturing facility?
A: The TEU-H65 is designed for solid dosage (non-sterile) manufacturing. For facilities requiring containment down to OEB 4-5 (highly potent compounds), we offer optional isolation packages including negative pressure cabin, continuous liner systems, and wash-in-place (WIP) capabilities. Please contact us for custom containment configurations.
Q3: How is cleaning validation supported?
A: All product contact parts disassemble without tools in under 15 minutes. The design eliminates dead spaces and crevices. We provide surface finish certification (Ra ≤ 0.8μm standard, Ra ≤ 0.4μm optional), material certifications, and full cleaning validation support documentation including recommended cleaning agents and procedures.
Q4: What documentation comes with the machine for regulatory filing?
A: Standard documentation includes: CE declaration, material certifications (SUS304/SUS316), surface finish reports, IQ/OQ/PQ protocol templates, Factory Acceptance Test (FAT) report, Site Acceptance Test (SAT) protocol, control system validation package, and 21 CFR Part 11 compliance documentation.
Q5: How long does a product changeover take?
A: A complete deep cleaning and formulation changeover typically takes 1.5-2.5 hours depending on operator experience. Recipe parameters for up to 50 products are stored in the PLC and recalled via touchscreen in seconds.
Q6: Can the TEU-H65 handle modified-release and combination bi-layer tablets?
A: Yes. This is one of its primary applications. The independent compression control for each layer allows precise engineering of immediate-release and sustained-release profiles within a single bi-layer tablet. It is widely used for combination tablets requiring controlled release kinetics.
Q7: Do you provide on-site validation support?
A: Yes. Our engineering team provides on-site installation, commissioning, IQ/OQ execution, and operator training. We also offer periodic requalification services and calibration support for the compression force sensors and control instrumentation.
Q8: What are the payment and delivery terms?
A: Standard payment terms are T/T with 30-45 working days delivery after deposit confirmation. Express delivery options and installation scheduling are available to align with your facility qualification timelines.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Exporter
Year Established:
2014 Year
Ecer Certification：
Verified Supplier
Since its establishment in 2014, TIWIN INDUSTRY has accumulated over a decade of valuable industry experience, becoming a trusted and leading supplier in the sector. We specialize in providing high-quality machinery and production line solutions for the pharmaceutical, food, and chemical industries,... Since its establishment in 2014, TIWIN INDUSTRY has accumulated over a decade of valuable industry experience, becoming a trusted and leading supplier in the sector. We specialize in providing high-quality machinery and production line solutions for the pharmaceutical, food, and chemical industries,...
