| The pharmaceutical, biotechnology and medical device industries have been some of the fastest growing industries in the U.S. in recent years. The life science services of Wunderlich-Malec are designed to help our clients realize their strategic business objectives in these industries, such as constructing new facilities, introducing new products, changing-over products, increasing productivity, improving product quality, ensuring regulatory compliance and meeting growth objectives by leveraging automation technologies.
Wunderlich-Malec has a wealth of experience providing innovative automation and control solutions for manufacturing, distribution and R&D systems for the life science industries. Starting with the feasibility and budgeting phase, we can work with you right through requirement specifications, detailed design, implementation, installation, start-up, testing, commissioning and qualification. We have experience with all major Programmable Logic Controllers (PLC) and Distributed Control Systems (DCS), Human Machine Interface (HMI), and Supervisory Control and Data Acquisition (SCADA) systems.
Our flexibility, depth of talent and dedication to our customers' needs have been critical to our success. We utilize the latest proven technologies and software to deliver projects and services nationwide.
Our skilled technology teams can provide a full range of services in a turnkey contract, or they can augment your existing staff and help you in the following areas:
- Process control & instrumentation
- Batch applications (S88) – 21 CFR Part 11
- Validation services
- Specifications (URS, FRS, SDS, HDS)
- Software (PLC/DCS/HMI)
- On-site installation, testing, validation and commissioning support.
Planning
Planning is a fundamental part of every Wunderlich-Malec life science project. Our quality and project plans enforce an orderly progression of project activities and identify the schedule of validation documentation that must be delivered. For GMP-compliant manufacturing operations, our plans define the specific quality requirements, the quality assurance systems, the project development plan, and the responsibilities associated with process control system implementation and validation. Our quality and project plans are based on GAMP standards and are developed with the direct collaboration of our customers.
At Wunderlich-Malec, every project receives our commitment to quality and customer satisfaction, ensuring that our solutions are delivered on time and within budget. Whether your needs call for total turnkey project support or specialized services, Wunderlich-Malec is ready to assist you.
Product Expertise
- DCS Systems (Fisher Rosemount DeltaV)
- PLC Systems (Allen Bradley, GE Fanuc, Modicon, Siemens)
- SCADA Systems (GE Fanuc iFix, GE Fanuc Cimplicity, Iconics, Wonderware)
- HMI (PanelView, Automation Direct, IDEC)
- Data Historians (GE Proficy Historian, Wonderware InSQL, Rockwell Software RSSQL, Iconics HyperHistorian)
- Custom Reporting (Visual Basic, Crystal Reports, MSSQL, XML)
- S-88 Batch Applications
- 21 CFR Part 11 Applications
Process Expertise
- Bioreactors
- Fermenters
- Synthesizers
- EO sterilization chambers
- Autoclaves
- Lyophilizers
- Centrifugation systems
- Homogenization systems
- Recovery systems
- Chromatography systems
- UF/DF systems
- Purification systems
- Process skids
- CIP/SIP
- High purity water
- HVAC
Project Execution Expertise
- Quality and Project Plan (QPP)
- User Requirement Specifications (URS)
- Functional Requirement Specifications (FRS)
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
- Requirements Traceability Matrix (RTM)
- Development Testing (DT)
- Factory Acceptance Testing (FAT)
- System Acceptance Testing (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- User manuals
- System Turnover Packages (TOP)
- Installation and startup
- Validation
- Commissioning
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