Pharmaceutical & Biopharmaceutical

Pharmaceutical and biopharmaceutical processes demand uncompromising quality, rigorous sanitation, and strict regulatory adherence. At Senti Solutions, we specialize in designing and manufacturing CRN and ASME-certified equipment, ranging from stainless steel reactors and sanitary vessels to advanced automation systems, tailored to meet cGMP and other critical industry standards. Our full-service approach covers concept, design, fabrication, installation, and validation, ensuring the highest levels of safety and performance. Whether you’re developing new vaccines or scaling biologics production, we’ll help you maintain compliance, optimize processes, and accelerate time-to-market.

Key Benefits & Differentiators

Ensuring the highest product quality demands an uncompromising commitment to sanitation, precision, repeatability, and regulatory compliance. At Senti Solutions, we merge engineering expertise with a deep understanding of cGMP guidelines to deliver process equipment that excels in both performance and dependability. By focusing on sanitary design, robust automation, and ongoing validation support, we help pharmaceutical and biopharmaceutical companies minimize contamination risks while streamlining production. Below are the key advantages that set our solutions apart:

• Regulatory Assurance
  Our equipment and processes can be built to meet 3A, ASME BPE 2016, EHEDG, and other sanitary standards required for cGMP operations.
• Aseptic & Sanitary Design
  Designed for clean-in-place (CIP)/steam-in-place (SIP) capabilities, full drainability, and with sanitary fittings and materials, our solutions reduce contamination risks and ensure easy validation of processes.
• End-to-End Expertise
  Comprehensive support — from initial design and system integration to validation and documentation.
• Scalable Solutions
  Flexible designs accommodate pilot programs, commercial-scale production, and everything in between.
• Advanced Automation
  Integrated control systems for precise monitoring and data logging, ensuring reproducible batch quality.

How It Works

Our team ensures we understand customer requirements, challenges, and regulatory hurdles in every custom pharmaceutical project. We take the following steps to ensure we are meeting client expectations:

1. Initial Assessment
   Our process begins with a detailed consultation to understand your specific production goals, regulatory environment, and facility constraints.
2. Design
   Next, our engineering team drafts a tailored solution, factoring in material compatibility, operational throughput, cleaning protocols, and required certifications.
3. Fabrication
   Once approved, fabrication takes place in our Canadian facility, adhering to CRN, ASME, and cGMP guidelines. The QC team maintains stringent records for full traceability of materials.
4. Inspection and Testing
   We perform thorough factory acceptance testing (FAT), verifying design specifications and ensuring that each piece of equipment meets performance benchmarks. These tests include validation of customer specifications such as materials, surface finishes, etc., borescoping welds, pressure tests, and more.
5. Installation/Commissioning
   After successful tests, our team coordinates delivery, on-site installation, and commissioning. We also provide validation support, including documentation and compliance checks, so you can seamlessly integrate your new systems into existing workflows. Where required, we provide clients with records to assist with IQ/OQ/PQ.
6. Turnover Package
   Our team maintains a comprehensive turnover package including required documents such as Material Test Reports (MTRs), Certificates of Compliance, Weld maps, Inspection records, and more. This Turnover package is provided to customers in GMP applications, allowing QC departments to validate the equipment is to standard.

High quality equipment solutions for cGMP processes

Ready to enhance your pharmaceutical or biopharmaceutical facility with easily validated, compliant, high-precision process equipment? Whether you’re scaling up a biologics line or launching a new vaccine platform, our custom-engineered solutions can accelerate production and maintain the highest quality standards.