Services
1. Curated Technology Selection for Chromatography Workflows
Choosing the appropriate technology is critical for both process efficiency and regulatory compliance. We provide custom-curated solutions for your application, whether it’s peptide purification, oligonucleotide synthesis, API isolation, or natural product extraction
Technologies We Support:
- Prep HPLC systems range from semi-automated to completely automated, and are scalable from R&D to production.
- LPLC Systems – Resin-based separations are suited for big biomolecules and raw extract purification.
- Column Packing Stations
- Chromatography skids (modular or skid-mounted)
- Chromatography Columns – Available in glass, acrylic, or stainless steel, and scalable from laboratory to production size.
- Data Management and Control Software: Integration with LIMS and SCADA.
We collaborate with top OEMs and integrators to ensure that all components meet process safety and regulatory requirements.
2. Facility Design & Turnkey Solutions
Our engineering team offers comprehensive design services for chromatography-based manufacturing, peptide synthesis, and laboratory-scale facilities. Proper layout and facility planning are essential for performance, compliance, and simplicity of operation.
Design Services Include:
Room layout design
- Designated zones for chromatography equipment, peptide synthesis modules, solvent storage, and waste collecting.
- Space allocation for mobile skids, permanent instruments, peptide synthesis workstations, and column handling.
Utility Planning:
- Electric load planning for high-power Prepare HPLC/LPLC systems and peptide synthesizers.
- Solvent-resistant drainage and ventilation systems
- Gas line integration (e.g., nitrogen purging for peptide chemistry).
- RO/DI water and air utilities based on system requirements.
Safety and Compliance:
- ATEX-rated areas for explosion-proof peptide synthesis settings.
- Ventilation and solvent vapor detection devices for safe peptide chemistry.
Environmental Control:
- Cleanroom integration for GMP-compliant peptide and chromatography suites.
- Process-critical regions are zoned according to ISO class (e.g., ISO 7/8).
Instrumentation infrastructure
- Cable trays, tubing, column handling platforms, and lifts.
- Equipment pass-throughs and service access panels.
- Scalable vessels for peptide synthesis, from research and development to production.
- Integration of peptide synthesizers with automation modules for high-throughput peptide production.
Peptide Automation Projects:
- Design and implementation of automated solid-phase peptide synthesis (SPPS) systems
- Modules for inline cleavage, washing, and filtration.
- Automated resin and solvent delivery systems
- Integrate with downstream Prepare HPLC/LPLC purification for complete peptide processes.
Our designs are compliant with FDA, EU-GMP, and ATEX standards, guaranteeing that your facility is audit-ready, future-proof, and optimized for chromatography and peptide drug development workflows.
3. Annual Maintenance Contract (AMC) Services for Prep HPLC and LPLC
Chromatography Systems.
We specialize in AMC services for a wide range of Preparative High-Performance Liquid Chromatography (Prep HPLC) and Low-Pressure Liquid Chromatography (LPLC) systems, including third-party support.
What We Offer:
- Preventive maintenance: Scheduled checks, calibrations, and system cleaning to avoid unexpected failures.
- Breakdown Support: Priority-based, timely response to any equipment breakdowns, resulting in minimal downtime.
- Spare Parts administration: The availability and administration of OEM or equivalent-quality spares.
- System validation and documentation: Compliance with cGMP and regulatory documentation standards.
- Performance optimization: entails adjusting flow rates, pressure restrictions, and detecting systems to ensure maximal efficiency.
Our technicians have received GMP training and understand the importance of purity, throughput, and reproducibility in pharmaceutical chromatography workflows.
4. Certifications & Compliance Standards
Every service and solution we provide is designed with safety, quality, and regulatory compliance in mind. We ensure that all equipment, instruments, and facilities, including the peptide synthesis and chromatography setups, meet the highest global standards.
Key Certifications & Compliance Standards:
- Equipment created and approved for use in potentially explosive environments is known as an ATEX explosion-proof system.
- CE Marking: Applicable to systems sold in Europe.
- cGMP Compliance: Peptide synthesis and bioprocess procedures are included in designs and documentation that adhere to current Good Manufacturing Practices.
- Electrical safety and hazard protection in accordance with international standards are provided by UL and IECEx certified components.
- Part 11 of 21 CFR Readiness: Automated peptide workflows with software validation and audit trail management.
- Support for the creation of peptide drug substances, including process design, manufacturing, and validation, is required to comply with ICH Q7 and Q11 guidance.
- Peptide GMP Standards: Adherence to facilities and equipment for commercial, pilot, and research and development peptide synthesis activities.
We also assist clients with audits and inspections by providing technical dossiers, FAT/SAT reports, validation paperwork, and risk assessments, guaranteeing that your chromatography and peptide manufacturing facilities are fully audit ready.
5. Instrumentation for Hazardous Environments – ATEX-Certified Solutions
Certain operations use solvents and gasses in potentially explosive environments. We provide ATEX-certified instrumentation designed to work securely in Zone 1/Zone 2 classified regions.
Key Features:
- ATEX-Certified Enclosures (pumps, detectors, control panels)
- Intrinsically Safe Electrical Components
- Flame-Proof Junction Boxes & Cabling
All explosion-proof equipment comes with certificates of conformity, installation instructions, and engineering assistance.
6. Instrument Design, Assembly & Customization
We develop and build specialized chromatographic instruments and peptide synthesis equipment to meet unique project requirements or facility limits.
Our Abilities:
- Instrument Configuration and Mounting Design (either frame-mounted or skid-mounted)
- Optimization of Tubing and Flow Path (PTFE, PEEK, and stainless steel)
- Custom Columns: scalable from research and development to production size, made of stainless steel, glass, or acrylic
- Personalized Column Supports & Injection Loops
- Integration of Inline Sensors (UV Absorbance, pH, Conductivity, Temperature, and Pressure)
- GMP-grade enclosures (panels with powder coating or stainless steel)
- Peptide synthesis vessels range from laboratory to industrial scale and can be used with automated or manual processes.
- Peptide Automation Projects: Combining purification skids, cleavage modules, and automated synthesizers for comprehensive workflows
We work with your process team to make sure the instruments are scalable as operations expand, easy to maintain, and ready for validation.
7. Instrument Qualification & Validation Support
We provide full qualifying services for every system we install or manage, guaranteeing regulatory compliance.
Qualification Services:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Calibration Protocols
- GMP-Compliant Documentation
We help ensure your systems fulfill FDA, EU-GMP, and ICH Q7 regulations.
1. Curated Technology Selection for Chromatography Workflows
Choosing the appropriate technology is critical for both process efficiency and regulatory compliance. We provide custom-curated solutions for your application, whether it’s peptide purification, oligonucleotide synthesis, API isolation, or natural product extraction
Technologies We Support:
- Prep HPLC systems range from semi-automated to completely automated, and are scalable from R&D to production.
- LPLC Systems – Resin-based separations are suited for big biomolecules and raw extract purification.
- Column Packing Stations
- Chromatography skids (modular or skid-mounted)
- Chromatography Columns – Available in glass, acrylic, or stainless steel, and scalable from laboratory to production size.
- Data Management and Control Software: Integration with LIMS and SCADA.
We collaborate with top OEMs and integrators to ensure that all components meet process safety and regulatory requirements.
2. Facility Design & Turnkey Solutions
Our engineering team offers comprehensive design services for chromatography-based manufacturing, peptide synthesis, and laboratory-scale facilities. Proper layout and facility planning are essential for performance, compliance, and simplicity of operation.
Design Services Include:
Room layout design
- Designated zones for chromatography equipment, peptide synthesis modules, solvent storage, and waste collecting.
- Space allocation for mobile skids, permanent instruments, peptide synthesis workstations, and column handling.
Utility Planning:
- Electric load planning for high-power Prepare HPLC/LPLC systems and peptide synthesizers.
- Solvent-resistant drainage and ventilation systems
- Gas line integration (e.g., nitrogen purging for peptide chemistry).
- RO/DI water and air utilities based on system requirements.
Safety and Compliance:
- ATEX-rated areas for explosion-proof peptide synthesis settings.
- Ventilation and solvent vapor detection devices for safe peptide chemistry.
Environmental Control:
- Cleanroom integration for GMP-compliant peptide and chromatography suites.
- Process-critical regions are zoned according to ISO class (e.g., ISO 7/8).
Instrumentation infrastructure
- Cable trays, tubing, column handling platforms, and lifts.
- Equipment pass-throughs and service access panels.
- Scalable vessels for peptide synthesis, from research and development to production.
- Integration of peptide synthesizers with automation modules for high-throughput peptide production.
Peptide Automation Projects:
- Design and implementation of automated solid-phase peptide synthesis (SPPS) systems
- Modules for inline cleavage, washing, and filtration.
- Automated resin and solvent delivery systems
- Integrate with downstream Prepare HPLC/LPLC purification for complete peptide processes.
Our designs are compliant with FDA, EU-GMP, and ATEX standards, guaranteeing that your facility is audit-ready, future-proof, and optimized for chromatography and peptide drug development workflows.
3. Annual Maintenance Contract (AMC) Services for Prep HPLC and LPLC
Chromatography Systems.
We specialize in AMC services for a wide range of Preparative High-Performance Liquid Chromatography (Prep HPLC) and Low-Pressure Liquid Chromatography (LPLC) systems, including third-party support.
What We Offer:
- Preventive maintenance: Scheduled checks, calibrations, and system cleaning to avoid unexpected failures.
- Breakdown Support: Priority-based, timely response to any equipment breakdowns, resulting in minimal downtime.
- Spare Parts administration: The availability and administration of OEM or equivalent-quality spares.
- System validation and documentation: Compliance with cGMP and regulatory documentation standards.
- Performance optimization: entails adjusting flow rates, pressure restrictions, and detecting systems to ensure maximal efficiency.
Our technicians have received GMP training and understand the importance of purity, throughput, and reproducibility in pharmaceutical chromatography workflows.
4. Certifications & Compliance Standards
Every service and solution we provide is designed with safety, quality, and regulatory compliance in mind. We ensure that all equipment, instruments, and facilities, including the peptide synthesis and chromatography setups, meet the highest global standards.
Key Certifications & Compliance Standards:
- Equipment created and approved for use in potentially explosive environments is known as an ATEX explosion-proof system.
- CE Marking: Applicable to systems sold in Europe.
- cGMP Compliance: Peptide synthesis and bioprocess procedures are included in designs and documentation that adhere to current Good Manufacturing Practices.
- Electrical safety and hazard protection in accordance with international standards are provided by UL and IECEx certified components.
- Part 11 of 21 CFR Readiness: Automated peptide workflows with software validation and audit trail management.
- Support for the creation of peptide drug substances, including process design, manufacturing, and validation, is required to comply with ICH Q7 and Q11 guidance.
- Peptide GMP Standards: Adherence to facilities and equipment for commercial, pilot, and research and development peptide synthesis activities.
We also assist clients with audits and inspections by providing technical dossiers, FAT/SAT reports, validation paperwork, and risk assessments, guaranteeing that your chromatography and peptide manufacturing facilities are fully audit ready.
5. Instrumentation for Hazardous Environments – ATEX-Certified Solutions
Certain operations use solvents and gasses in potentially explosive environments. We provide ATEX-certified instrumentation designed to work securely in Zone 1/Zone 2 classified regions.
Key Features:
- ATEX-Certified Enclosures (pumps, detectors, control panels)
- Intrinsically Safe Electrical Components
- Flame-Proof Junction Boxes & Cabling
All explosion-proof equipment comes with certificates of conformity, installation instructions, and engineering assistance.
6. Instrument Design, Assembly & Customization
We develop and build specialized chromatographic instruments and peptide synthesis equipment to meet unique project requirements or facility limits.
Our Abilities:
- Instrument Configuration and Mounting Design (either frame-mounted or skid-mounted)
- Optimization of Tubing and Flow Path (PTFE, PEEK, and stainless steel)
- Custom Columns: scalable from research and development to production size, made of stainless steel, glass, or acrylic
- Personalized Column Supports & Injection Loops
- Integration of Inline Sensors (UV Absorbance, pH, Conductivity, Temperature, and Pressure)
- GMP-grade enclosures (panels with powder coating or stainless steel)
- Peptide synthesis vessels range from laboratory to industrial scale and can be used with automated or manual processes.
- Peptide Automation Projects: Combining purification skids, cleavage modules, and automated synthesizers for comprehensive workflows
We work with your process team to make sure the instruments are scalable as operations expand, easy to maintain, and ready for validation.
7. Instrument Qualification & Validation Support
We provide full qualifying services for every system we install or manage, guaranteeing regulatory compliance.
Qualification Services:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Calibration Protocols
- GMP-Compliant Documentation
We help ensure your systems fulfill FDA, EU-GMP, and ICH Q7 regulations.