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HTSE provides automation and validation solutions to some of the world’s largest pharmaceutical companies. We possess extensive knowledge and experience in the automation and validation of pharmaceutical process and packaging line control systems. We possess a thorough understanding of regulatory compliance requirements for pharmaceutical processes and facilities. We are also experienced with pharmaceutical utility and facility systems such as HVAC, Compressed Air, WFI, and purified water systems.
HTSE has pharmaceutical-experienced engineering staff that can lead and execute pharmaceutical projects. We understand the deliverables of a pharmaceutical project and have the requisite experience required for the development of the control system along with the generation and execution of:
- Validation Master Plans
- User Requirements
- Functional Specifications
- Design Documents
- Factory Acceptance Tests
- Impact Assessments
- Installation Qualifications
- Operational Qualifications
- Controls / Automation Qualifications
- Computer Systems Validation
- Performance Qualifications
- Disaster Recovery Procedures
- SOP Development
HTSE offers proven successful project methodologies that comply with Current Good Manufacturing Processes (cGMP). We possess a broad spectrum of pharmaceutical experience to control and qualify your systems and equipment.
Our portfolio includes the successful completion of hundreds of projects in the areas of:
Process Control
- Pressure, Temperature, and Flow Control
- Batching Control Systems
- Continuous Control Systems
- HVAC Controls
- Process Manufacturing Equipments i.e. Tank farms, Heat Exchangers, Fluidizing Beds, Transporters, Dryers, etc.
- Utilities i.e. Steam, Compressed Air, etc.
- Potable and Purified Water Systems
- Environmental Monitoring
Packaging Automation
- Powder and liquid fillers, Cartoners, Checkweigh systems, Collators, Bundlers, Labelers, Casepackers, Sorters, Palletizers, Packaging Line Integration
- Barcode and Vision Systems
- Motion Control
- PLC Programming – Machine and Line Control
- HMI – SCADA and Machine and Line Control
- Environmental Monitoring
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