Engineering

Our Key Area of Life Science Services

Engineering for the Life Sciences is our primary area of expertise at PSC Biotech®.

At PSC Biotech®, our Engineers focus on the engineering needs of pharmaceutical and medical device manufacturing in the life sciences. At the core, PSC Engineers take a risk-based approach; thus, we always work with ICH Q9 guidelines in place. We have qualified and experienced engineers in over 35 countries to serve your new, existing, or decommissioning production site.

On an essential level, we provide:

    • Engineering Support
    • Engineering Drawings
    • Engineering SOPs
    • Redline Piping and Instrumentation Diagrams (P&IDs)
    • Support Preventative Maintenance
    • Product Specifications
    • Hazard Analysis

For higher level engineering needs, we provide:

    • Certification Programs for Capital Projects
    • Lifecycle Management for Process, Facility, and Utility Systems
    • Program Management and Governance for engineering projects
    • Ensure compliance with Environmental Health and Safety (EH&S)
    • Technical Documentation and Writing – SOPs / LOTO Procedures / Global Harmonization / Risk Assessments / Training documentation creation and performing training
    • Design creation and review for early project stages (room classification, P&ID review, creation of review, etc.

Key Focus Areas:

    • Health And Safety
    • Documentation
    • Control Design
    • Change Control
    • Validation
    • Commissioning
    • Testing

Furthermore, PSC Biotech® assigns a Project Manager to each Engineering project. The Project Manager utilizes our exclusively developed Project Tracker (PT) software to maintain an accurate and up-to-date deliverable document status. With years of expertise and regulatory awareness, our engineers execute projects in a highly efficient manner to meet your needs as soon as possible. See our project success pages for examplesContact us for a customized assessment and cost estimate.

    As an example of PSC Biotech® Engineer’s focus on Quality, Validation, and Documentation, here are some ways we’ve helped clients and what we can do for you:

    Quality

      • 21 CFR Part 211/210/820, ISO 13485 and FDA regulation compliance
      • Developing, amending, and implementing standard GMPs/SOPs
      • Implementing continuous improvements
      • Developing and improving production processes
      • Conducting complaint investigations and audits
      • Performing root cause analysis/NCRs for production
      • Resolving quality issues
      • Conducting engineering analyses

    Validation – installation, operations, performance

      • Sterilization – Autoclaves, Sterilization-In-Place (SIP), Clean-In-Place (CIP) , freezers, Lyophilization Cabinets, Ointment Filler, and other Aseptic Equipment
      • Laboratory and Production equipment –Bioreactors, HPLC’s, GC’s, FTIR, ovens, filling machines, process mixers, process tanks, and freezers
      • Utilities – Electrical, Compressed Air, Nitrogen Systems, and HVAC
      • Drafting, editing, reviewing, and executing protocol

    Documentation – developing, amending, implementing

      • Compliance – cGMP, SOPs, batch records, validation documents
      • Reviewing 21 CFR Part 211/210/820, ISO 13485 and FDA regulation adherence
      • Functional specifications, systems designs, and process flow diagrams
      • Transferring existing protocols to new standard templates,
      • Developing new manufacturing processes and equipment technologies,
      • Designing and qualifying new processes
      • Developing training material
      • Creating test method protocols
      • Writing master validation plans
      • Master validation schedules

    What Our Clients are Saying

    “During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

    “The skillsets that PSC provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC was very independent and if we had an issue, PSC consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC. Just phenomenal! It made my life easier.”

    “This is to certify that PSC Biotech® (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

    How Can We Help You?

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