Double Rotary Tablet Press Installation Qualification (IQ)

Double Rotary Tablet Press Installation Qualification (IQ): A GMP-Focused Overview

The double rotary tablet press is a high-output compressing machine critical for the manufacture of oral solid dosage (OSD) forms in pharmaceutical production environments. It enables the precise compaction of powder blends or granules into uniform tablets, supporting both high-volume throughput and stringent consistency requirements. Placement of this equipment is typically downstream from blending and granulation, and directly upstream of primary packaging operations. Its use in regulated environments is conditioned by Good Manufacturing Practice (GMP) standards to ensure product quality and patient safety.

Scope and Boundaries for Equipment Qualification

The Installation Qualification (IQ) of a double rotary tablet press typically covers the verification that the equipment is received as specified, is correctly installed, and integrates with facility utilities appropriately. The IQ process focuses on:

• Verification of equipment components, assemblies, and subassemblies against the engineering drawings and supplier documentation
• Assessment and documentation of all associated utilities (power, compressed air, dust extraction interfaces, etc.)
• Validation of critical safety features, earthings, and interlocks
• Documentation of hardware and software versions (where applicable)
• Review of materials of construction for product contact parts
• Confirmation of instrument calibration certificates and equipment manuals availability

Out of scope for double rotary tablet press IQ:

• Process qualification and performance qualification of the tablet press
• Operator training and routine maintenance activities
• Qualification of associated auxiliary equipment (e.g., metal detectors, dedusters) unless explicitly included in the system boundary
• Product and cleaning validation activities
• Analytical instrument calibration unrelated to the press itself

Criticality Assessment of the Double Rotary Tablet Press

Adequate evaluation of equipment criticality supports the risk-based qualification strategy required in modern GMP operations. The tableting press is designated as a critical process equipment due to its direct impact:

• Product Quality Impact: Controls critical attributes such as tablet weight, hardness, thickness, and uniformity, all essential for batch consistency and regulatory acceptance.
• Patient Risk: Any malfunction or misconfiguration may result in inaccurate dosing, compromised bioavailability, or unintentional exposure to excess or ineffective medication.
• Data Integrity: Integrated sensors and data logging (batch recording, compression force trends, batch counters) must be ensured tamper-proof and reliable, underpinning both electronic and paper records.
• Contamination Risk: Potential cross-contamination sources include improper cleaning, residual materials in product contact areas, and failure of dust extraction systems.
• EHS Risk: High moving parts and powder exposure risk require interlocked guards and efficient dust management to protect operators and environment.

GMP Expectations for Double Rotary Tablet Presses

The double rotary tablet press is subject to a range of GMP expectations, including documented evidence of suitable installation, material traceability, and maintenance of a controlled environment during qualification. Key GMP considerations include:

• Traceability: All product-contact components must be sourced with certification and tracked throughout their lifecycle.
• Change Control: Any modifications to installed systems, utilities or significant software/hardware revisions require documented change assessment and possible requalification.
• Calibration: Inbuilt sensors (e.g., pressure, force, tablet counters) require valid and current calibration certificates.
• Validation Life Cycle: IQ is just one part; overall validation links IQ to subsequent operational (OQ) and performance (PQ) stages.
• Documentation: All procedures, reports, calibration routines, and risk assessments must be available and reviewed by qualified personnel before PQ or commercial use.
• Cleanability: Documentation must confirm appropriate design for cleaning, access, and absence of dead-legs that could trap residues.
• Safety: Interlocks, guards, emergency stops, and e-stops are confirmed and approved as part of the IQ scope.

User Requirement Specification (URS) Approach

Precision in the User Requirement Specification (URS) is fundamental to the qualification process. A clear, well-scoped URS defines user expectations, compliance boundaries, and lays the foundation for design qualification and commissioning. Recommended sections of a URS for a double rotary tablet press typically include:

• Equipment Description: Maximum output, number of stations, compatibility with specific punch sizes.
• Safety & Compliance: Requirements for GMP, operator safety, and EHS provisions.
• Utilities: Power consumption, compressed air parameters, dust extraction compatibility.
• Automation & Controls: SCADA/HMI details, data recording, 21 CFR Part 11 compliance (if applicable).
• Cleanability & Maintenance: Documentation on quick-disassembly, cleaning processes, and changeover validation.
• Calibration & Verification: List of inbuilt measuring instruments and calibration requirements.

Example URS Excerpt:

• The tablet press shall have a minimum output of 240,000 tablets/hour at 16 mm diameter.
• Should support both “B” and “D” tooling without mechanical modification.
• Shall feature stainless steel AISI 316 product contact surfaces with roughness < 0.6 μm Ra.
• HMI system must have access controls and audit trails conforming to 21 CFR Part 11.
• Compressed air supply must be 6 bar (±0.5 bar), oil-free, and dry.
• Integrated dust extraction port designed for connection to 200 mm diameter ducting.

Risk Assessment Foundations for Double Rotary Tablet Press IQ

Designing an effective IQ protocol is underpinned by a formal risk assessment process, typically leveraging Failure Modes and Effects Analysis (FMEA) principles. Key risk factors considered include:

• Incorrect utility connections – leading to equipment malfunction or EHS incidents; addressed by detailed utility mapping and as-built drawing checks.
• Non-conforming materials of construction – risk of product contamination; controlled by visual and certification verification steps.
• Incomplete software system validation – risk of data integrity compromise or batch record loss.
• Unverified safety interlocks – risk of operator injury; mitigated by interlock tests during IQ.
• Calibration lapses – potential for unnoticed process drift; counteracted by requiring all sensor and gauge certificates during IQ.

Below is a sample table mapping critical IQ requirements to potential risks and the corresponding control or test:

By systematically applying these risk and control principles within the IQ protocol, organizations lay a robust foundation for the reliable, GMP-compliant operation of double rotary tablet presses in oral solid dosage manufacturing lines.

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Double Rotary Tablet Press Installation Qualification (IQ) for Oral Solid Dosage Forms

The double rotary tablet press is a critical piece of equipment in the oral solid dosage manufacturing environment, requiring a meticulously executed Installation Qualification (IQ) phase to ensure compliance with current Good Manufacturing Practices (cGMP). A robust IQ program covers supplier controls, factory acceptance testing, comprehensive design qualification reviews, and environmental and utility verifications aligned to user requirements and regulatory standards.

Supplier Controls for Double Rotary Tablet Press IQ

Thorough supplier controls are foundational for successful equipment qualification. Vendor qualification begins before procurement and must evidence that the supplier is capable of delivering a tablet press that meets all regulatory, technical, and operational requirements.

• Vendor Qualification: Assessment includes supplier audits, review of quality systems, regulatory history, and documentation of past performance with similar pharmaceutical machinery. Audits should prioritize hygienic design capabilities, change control processes, and adherence to cGMP manufacturing standards.
• Document Package: Upon delivery, the equipment must be accompanied by a comprehensive document package. Mandatory inclusions are:
  • Equipment manuals (operation, maintenance, cleaning)
  • Assembly and general arrangement drawings
  • Wiring and pneumatic schematic diagrams
  • List of critical and major components with specifications
  • Certificates of compliance or conformance for key parts
  • Calibration certificates for pre-assembled instrumentation
• Material Certificates: All product-contact parts must be supported by 3.1 material certificates as per EN 10204, demonstrating conformity with declared grade (e.g., SS316L for all contact surfaces) and traceability to manufacturing batches.
• Software Documentation (if applicable): For any programmable logic controllers (PLC), HMIs, or data acquisition components, the package must include:
  • Software version lists and release notes
  • Operation and security manuals
  • Backup installation media and password management policy
  • GAMP5-based software development lifecycle documentation for GMP-critical systems

Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) Strategy

FAT and SAT ensure that the double rotary tablet press operates per design intent before and after installation. These steps mitigate risks prior to executing IQ protocols on site.

• FAT Objectives: Performed at the supplier’s facility. Tests typically include verification of:
  • Mechanical operation (rotary motion, turret speed, loading/unloading of punches and dies)
  • Functionality of safety interlocks and emergency stops
  • HMI/SCADA screens and alarms
  • Component integrity comparing as-built configuration with approved design
• SAT Objectives: Conducted post-installation at the user site, mainly to confirm:
  • Utility connections meet specifications (air, power, water, vacuum)
  • Equipment reassembly integrity
  • Basic operation and integration with facility services
  • Start-up checks and dry runs
• Witnessing & Deviations: Client and QA representatives observe both FAT/SAT; deviations, if observed, are formally recorded, tracked, and resolved within the Final Qualification Report. All non-conformances must be risk-assessed for impact on product quality and patient safety.

Design Qualification for Double Rotary Tablet Press

Design Qualification (DQ) confirms that selected equipment and its components are suitable for the intended use, focusing on pre-defined user requirements. The DQ for a double rotary tablet press must review:

• Design Reviews: Cross-functional assessment of vendor’s technical proposal, design drawings, and process compatibility with GMP operations.
• Critical Drawings: Verification of component layout, punch/die configuration, maintenance access, and cleaning approach. Review of explosion and general arrangement drawings for accurate representation.
• Materials of Construction: Product contact surfaces must be corrosion-resistant (ideally SS316L), non-reactive, and easily cleanable; non-contact areas should be robust and resist lubricants, dust, and vibration.
• Hygienic Design: Evaluation of ease-of-cleaning, CIP/SIP provisions if present, dead-leg avoidance, and minimization of particulate retention points. Sealing, gaskets, and drive system enclosures must prevent ingress of lubricants into product zones.
• Compliance: Regulatory standards such as FDA cGMP, EU GMP, and local pharmacopeial requirements must be demonstrably met in all design elements.

IQ Planning and Execution for Double Rotary Tablet Press

Installation Qualification (IQ) is a structured process validating the correct installation and documentation status of the double rotary tablet press. The protocol encompasses the following major elements:

• Installation Checks: Physical verification that equipment is installed at the designated location per approved layout; anchorage, isolation pads, and levelness verified with calibrated tools.
• Utilities Verification: Confirmation that all utility connections (electrical, compressed air, vacuum, dust extraction, cooling water) meet design ratings. Voltage, phase, grounding, air flow/pressure, and other supply characteristics are measured and recorded.
• Instrumentation and Calibration: All critical gauges, pressure sensors, load cells, and encoders verified for proper installation and calibration status (traceable to national or international standards).
• Identification and Labelling: All panels, controls, and major assemblies labelled per plant nomenclature. Punch/die stations and safety devices individually tagged for traceability.
• Documentation Verification: Assembly and wiring drawings, calibration certificates, and as-built dossiers are checked for completeness and alignment with actual installation.
• Safety Checks: Verification of safety interlocks, emergency stop functions, guarding, and lockout/tagout compliance. Ensure proper functioning of alarms and power-down sequences.
• Environmental Verification: Ambient conditions (HVAC class), dust extraction performance, and local lighting verified and documented.

Environmental and Utility Dependencies

The suitability of supporting infrastructure is vital to the successful IQ of the double rotary tablet press. Key dependencies and example acceptance criteria include:

• HVAC Room Classification: Confirmation that the tablet compression suite meets ISO Class 8 or Grade D per local GMP guidelines. Temperature … 20–25°C, Relative Humidity … 40–60%RH, as per process URS.
• Compressed Air: Oil-free, dry air compliant with ISO 8573-1 Class 1.4.1; pressure at machine inlet as per OEM spec (e.g., 6 bar ±0.5 bar).
• Purified Water (PUW) or RO Water: Confirm supply at specified temperature, flow, and conductivity—especially for cleaning routines if CIP is enabled.
• Electrical Power Quality: Validate supply voltage (e.g., 415V, 3-phase, 50Hz, ±10%), earthing adequacy, and phase sequencing.
• Steam (if required): Confirm supply for any sterilization or humidity control functionality. Steam quality and pressure as per OEM and process requirement.
• Dust Extraction & Environmental Controls: Effective dust extraction system validated for maintaining area classification and protecting operator safety.

Double Rotary Tablet Press: Traceability Matrix

Supplier Package and DQ/IQ Readiness Checklist

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Operational Qualification (OQ) of Double Rotary Tablet Press: Ensuring Precision and Compliance

After the successful completion and satisfactory review of Installation Qualification (IQ) for a double rotary tablet press, the next critical validation step is Operational Qualification (OQ). OQ rigorously demonstrates that the press performs consistently and reliably within its operational specifications, under controlled conditions, with all critical alarm systems, interlocks, and safety features functioning as intended. Ensuring thorough OQ is foundational to maintaining compliance with GMP and regulatory requirements, minimizing product quality risks, and supporting robust batch recordkeeping.

Functional Tests and Operating Range Verification

The core of OQ for a double rotary tablet press is demonstration that all major functionalities operate within predetermined limits. This includes, but is not limited to:

• Main Drive Operation: Verifying that the motor starts, runs smoothly, and operates across the full RPM range (e.g., 10–70 RPM).
• Feeder Operation: Checking correct functioning and variable speed settings of force feeders, where installed.
• Tablet Compression: Challenging the press at minimum and maximum compression force settings (e.g., 3–100 kN, as per equipment capability).
• Weight Control System: Verifying function and accuracy of tablet weight regulation mechanisms.
• Lubrication System: Demonstrating automatic lubrication cycles and monitoring alarm activation for low oil levels.
• Deduster/Metal Detector Integration: If applicable, ensuring that ancillary devices function as intended in the production line configuration.

Setpoint Verification and Challenge Testing

During OQ, each critical operating parameter and associated control is deliberately set and tested for performance validation. This may involve stepwise adjustment of:

• Compression force setpoints (e.g., 10 kN, 30 kN, 50 kN – example values)
• Tablet thickness adjustment (e.g., 3.5 mm, 4.0 mm, 5.0 mm – as per tooling)
• Fill depth settings corresponding to expected tablet weights
• Rotation speed settings, monitoring tablet output and uniformity

Challenge tests simulate potential deviations or failures, validating alarms and system responses:

• Blocking feed system to trigger force feeder alarms
• Manually activating emergency stops to ensure instant cessation of operation and accurate alarm display
• Disconnecting safety guards to verify machine interrupts power/cycles
• Testing pressure relief valves by applying overpressure within controlled parameters

Alarms, Interlocks, and Safety Feature Verification

A double rotary tablet press includes a spectrum of engineering and software controls to protect personnel and equipment. All alarms, status indicators, and safety interlocks must be verified:

• Guards and doors must initiate immediate machine shutdown if opened or improperly seated; interlock integrity is confirmed through challenge tests.
• Emergency stop switches must de-energize all high-risk functions instantly, and require a reset and documented investigation to resume operations.
• All pressure, temperature, and oil level alarms must trigger local/audio alerts if critical thresholds are breached. For instance, a low lubrication alarm might trigger at <100 mL oil (example value).
• Indicator lamps, HMIs, or operator displays must provide unambiguous status feedback for key states (e.g., “ready,” “in operation,” “error,” “emergency stop activated”).
• Pressure relief valves and vent devices are challenged to ensure actuation at rated limits (e.g., above 5 bar, as specified).

Instrumentation Checks and Calibration Verification

All operational qualification activities must be supported by proper instrumentation. During OQ, the following must be systematically verified:

• Calibration status of all pressure, force, and temperature sensors must be current (within due date, with traceable certificates).
• Sensors and measurement devices are checked for accuracy via calibration standards or reference weights. For example, load cells may be challenged with known compressive loads (e.g., certified test weights).
• Any programmable logic controller (PLC) or digital HMI must be time-synced with manufacturing systems, ensuring data consistency across logs and records.

OQ and Data Integrity Controls for Computerized Systems

When a double rotary tablet press integrates computerized controls or automation, data integrity requirements become paramount during OQ. The system must uphold ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and others) through features such as:

• User Roles: Verifying that system logins enforce appropriate access controls (e.g., separate roles for operators, supervisors, QA personnel).
• Audit Trails: Ensuring all critical changes (e.g., parameter adjustments, alarm acknowledgments) are captured with timestamp, user ID, and description, and the audit trail is tamper-resistant.
• Time Synchronization: System clock checked for accuracy and documented time synchronization to site standards.
• Backup and Restore: Performing sample data or configuration backup, followed by restore procedures, confirming full data retrieval without loss or corruption.

GMP Controls: Line Clearance, Labeling, and Documentation Integration

Compliance with GMP documentation requirements is demonstrated at every phase of OQ. Controls include:

• Line Clearance: Ensuring production and surrounding areas are clear of previous product, labels, or residues before OQ execution and prior to batch manufacture.
• Status Labeling: Machine status tags (“Ready,” “Under Validation,” “Out of Service,” etc.) are displayed and updated as per SOPs.
• Logbooks: Operation, maintenance, and cleaning activities during OQ must be recorded in bound, validated logbooks or approved electronic systems.
• Batch Record Integration: OQ data, calibration checks, and relevant challenge results are appended or referenced in master batch records as needed, ensuring traceability.

Sample OQ Checklist for Double Rotary Tablet Press

All OQ executions for a double rotary tablet press must be comprehensively documented, deviations investigated, and supporting evidence (e.g., instrument calibration certificates, system audits, and functional logs) appended to the validation protocol. The OQ phase ensures that equipment performance is robust, alarms and controls are reliable, and that integration into GMP workflows is seamless and compliant.

The next sections continue the qualification storyline with practical tests, evidence expectations, and lifecycle controls appropriate for this equipment.

Performance Qualification (PQ) for Double Rotary Tablet Presses

Performance Qualification (PQ) is the definitive phase in double rotary tablet press IQ and the entire equipment validation lifecycle. PQ demonstrates that the installed tablet press consistently operates within predetermined specifications under actual or simulated production conditions. This phase ensures not only the routine manufacturing demands but also robustness under stressed (“worst-case”) scenarios, encompassing variability in materials, operator shifts, environmental ranges, and scale of operation.

Routine and Worst-case Strategies

PQ for a double rotary tablet press entails executing comprehensive test runs using product formulations or placebo blends at intended batch sizes. Both routine and worst-case operating scenarios are included:

• Routine Operation: Uses standard formulation and batch size under nominal environmental and machine settings.
• Worst-case Conditions: Includes highest and lowest tablet weights, thickest and thinnest tablets, slowest and fastest machine speeds, and usage of the largest number of stations and tooling permutations. This might also explore operator variabilities and near-maximum/minimum environmental conditions (humidity and temperature).

PQ Sampling Plan and Acceptance Criteria

Sampling is performed at multiple points across the run—startup, during steady-state operation, and at shutdown—using a statistically justified plan. Representative sampling covers different punch stations, turret positions, hopper depletion points, and collection timeframes. This helps verify repeatability (within a run) and reproducibility (across different runs/batches, shifts, or operators).

Additional tests can include thickness, diameter, disintegration, and visual inspection for physical defects. All acceptance criteria should be protocolized and justified based on registered specifications and historical performance.

Cleaning and Cross-Contamination Controls

Since double rotary tablet presses are product-contact equipment, PQ also interacts with cleaning validation or verification efforts. Each PQ run is either preceded or followed by validated cleaning procedures, with surface swab or rinse samples taken from critical points (punches, dies, hopper, tablet chute) to confirm residue and carryover levels are within acceptable limits. Typical acceptance limits align with health-based exposure thresholds or established toxicological limits.

PQ scenarios may include “worst-case” cleaning conditions, such as the dirtiest or most difficult-to-clean formulations, minimum cleaning cycles, or prolonged holding times before cleaning. Demonstrating effective cleaning under such scenarios provides assurance against cross-contamination and supports multi-product equipment use.

Continued Process Verification and Qualification

Validation does not end at PQ. Ongoing (stage 3) verification is crucial for a lifecycle approach, ensuring the double rotary tablet press remains in a state of control. This typically involves:

• Periodic trending of critical process parameters (e.g., compression force, feeder speed, weight variation) against historical PQ data
• Review of batch records and deviation logs for recurring or abnormal issues
• Routine equipment performance checks (e.g., challenge tests for sensors)

Requalification is triggered by significant change—such as punch/die changes, software updates, major repairs, or adverse product quality trends—under formal change control.

SOPs, Training, Preventive Maintenance, and Change Control

• Standard Operating Procedures (SOPs): Comprehensive procedures must be in place for equipment setup, operation, cleaning, maintenance, and troubleshooting. Each SOP must reflect actual PQ-verified practices and reference qualification data.
• Training: Operators and maintenance personnel require documented, equipment-specific training. A qualified operator should demonstrate proficiency as evidenced during PQ runs.
• Preventive Maintenance (PM): PQ results should inform PM schedules—such as punch and die inspection intervals, lubrication routines, and sensor calibration. PM records need to be reviewed to correlate with process capability.
• Calibration Program: All critical measuring and controlling instruments (load cells, pressure transducers, speed sensors) must be within a valid calibration period at PQ, and regularly calibrated thereafter.
• Spare Parts Management: Ensure availability of critical spares (punches, dies, motors, sensors) as identified by PQ failure modes or preventive maintenance experience.

Change Control, Deviations, and CAPA

Robust change control processes are paramount. Any proposed change—hardware, software, SOP revisions, cleaning procedures—must be documented, risk-evaluated, and, if necessary, followed by partial or full requalification. Deviations encountered during PQ (e.g., out-of-limit results, process alarms, mechanical failures) should be thoroughly investigated, impact assessed, and closed via a risk-based Corrective and Preventive Action (CAPA) system. All CAPAs related to PQ must be documented and their efficacy verified prior to final qualification approval.

Validation Deliverables: Protocol, Report, and Traceability

PQ Protocol Structure typically includes:

• Objective and scope
• Responsibilities and approval signatures
• Test descriptions and rationale
• Sampling plan and locations
• Acceptance criteria (with justification)
• Data collection and recording templates
• Deviation management process
• References to current SOPs and calibration certificates

Upon completion, a comprehensive PQ Summary Report should:

• Summarize test results and deviations
• Provide graphical/trended data where applicable
• Present a clear statement of acceptance or required actions
• Reference executed protocols, raw data sheets, calibration records, training documents, and CAPA close-outs
• Include a traceability matrix linking each protocol requirement to specific executed evidence (ensuring regulatory reviewers can readily assess completeness)

The final documentation set forms the basis for ongoing monitoring and provides auditable evidence that the double rotary tablet press IQ approach delivers consistent product quality in the oral solid dosage manufacturing environment.

Frequently Asked Questions (FAQ) – Double Rotary Tablet Press IQ

1. What is the “IQ” component for a double rotary tablet press?

IQ, or Installation Qualification, confirms that the double rotary tablet press and its associated utilities are installed according to design specifications, manufacturer’s recommendations, and regulatory requirements. It is the first, fundamental validation step for the equipment.

2. How does PQ differ from IQ and OQ for tablet presses?

PQ (Performance Qualification) verifies performance under actual or simulated production conditions, while IQ ensures correct installation, and OQ (Operational Qualification) confirms that all features function as intended under a range of parameters before actual products are involved.

3. What are critical acceptance criteria for PQ runs?

Criteria include tablet weight, hardness, thickness, appearance, friability, and machine alarms; all must meet specified ranges from the PQ protocol, typically reflecting registered product specifications and worst-case scenarios.

4. How does cleaning validation relate to double rotary tablet press IQ?

Cleaning validation ensures that the tablet press does not retain residues or cause cross-contamination between batches or products. This is verified via swab/rinse tests incorporated into PQ runs post-IQ and OQ, using protocols aligned with regulatory health-based limits.

5. When should double rotary tablet press PQ be repeated?

PQ should be repeated (requalification) after significant changes such as new tooling, major repairs, software upgrades, shifts in product type, or consistently out-of-trend process data, all managed under formal change control procedures.

6. What role does operator training play in equipment qualification?

Operator competency is a pivotal variable in PQ; evidence of thorough, equipment-specific training is required, and operators must demonstrate proficiency during PQ batches.

7. What are common PQ challenges on double rotary tablet presses?

Frequent issues include tablet weight deviation, sticking, capping, machine sensor failures, and cleaning inefficacy. Proactive maintenance and careful protocol preparation help mitigate these risks.

8. Is a PQ summary report mandatory, and what should it include?

Yes. A PQ summary report must consolidate results, deviations, CAPA, final conclusions, supporting documentation, and a traceability matrix, providing a holistic record for audit purposes.

Conclusion

The validation and qualification of a double rotary tablet press, culminating in robust Performance Qualification (PQ), is essential for delivering consistent, high-quality oral solid dosage forms in GMP environments. Through a disciplined and equipment-tailored double rotary tablet press IQ approach, manufacturers safeguard product safety, regulatory compliance, and operational reliability. Lifecycle-minded documentation, vigilant change control, and ongoing process verification together secure the sustained qualified state of the tablet press, supporting the highest standards of pharmaceutical manufacturing.