At Stelic, we understand the critical role that life sciences facilities play in advancing scientific research, developing innovative therapies, and improving patient outcomes. Whether you’re building a new state-of-the-art research laboratory, upgrading an existing manufacturing plant, or implementing a cGMP-compliant production facility, our team has a proven track record of delivering life sciences projects of various scales, from small-scale R&D labs to large-scale biomanufacturing complexes.
We Understand Life Sciences
Regulations
Deep understanding of the intricate network of regulations and standards governing life sciences facility construction projects, including the Food and Drug Administration (FDA) Current Good Manufacturing Practices (cGMP), the International Society for Pharmaceutical Engineering (ISPE) Baseline Guides, and the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
CONTAMINATION CONTROL
Knowledgeable in life sciences facilities that optimize contamination control, cleanroom design, and bio-containment strategies, ensuring the highest levels of product quality and patient safety.
Permitting
Extensive experience navigating the complex permitting and approval processes associated with life sciences projects, including facility licensing, environmental assessments, and compliance with local, state, and federal regulations, such as the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) requirements.
DESIGN
Insight into cutting-edge design practices, such as flexible modular construction, single-use technologies, and advanced automation systems, that comply with industry standards, such as the International Organization for Standardization (ISO) 14644 (Cleanrooms and Associated Controlled Environments) and the Good Automated Manufacturing Practice (GAMP) guidelines.
TYPE
Expertise in a wide range of life sciences facilities, including research laboratories, pilot plants, biomanufacturing facilities, and fill-finish operations, adhering to specific requirements, such as biosafety levels (BSL), current Good Laboratory Practices (cGLP), and current Good Tissue Practices (cGTP).
IOQ, PQ, and EMPQ
Proficient in the development and execution of comprehensive Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Environmental Monitoring Performance Qualification (EMPQ) protocols, ensuring that all critical systems and equipment are properly installed, validated, and perform as intended, in compliance with regulatory requirements and industry best practices.
COORDINATION
Develop phased construction plans and temporary facilities that minimize disruption to ongoing life sciences operations, utilizing shutdowns and commissioning strategies, and collaborating closely with facility stakeholders, including scientists, engineers, and quality assurance personnel.
INFRASTRUCTURE
Understanding of life sciences facility construction that prioritizes flexibility, scalability, and adaptability, incorporating modular utility systems, single-use process equipment, and advanced building automation systems to accommodate future changes in research priorities, production capacity, and regulatory requirements.
QUALITY
Track record of delivering life sciences projects that meet the highest standards of quality, safety, and compliance, with a rigorous commissioning, qualification, and validation (CQV) process that includes risk assessments, design reviews, and performance testing to ensure adherence to all relevant regulations, standards, and industry best practices, such as the ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment).
Customization
Work closely with our life sciences clients to develop customized solutions that align with their unique research goals, manufacturing processes, and business objectives, employing value engineering, process simulation, and risk management techniques to optimize the long-term performance, efficiency, and compliance of each life sciences facility, while ensuring strict adherence to quality, safety, and regulatory standards.
