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Services Provided
Typical services that can be provided to clients are:
Process Engineering
- Design of unit operations for food, pharmaceutical, industrial and chemical industries involving fluid, mass and heat transfer
- Design of heating and cooling processes for batch or continuous processes
- Water purification systems for all types of applications and industries
- Design and/or project management for the development of new processes or prototype machinery
- Reaction engineering including mixing and scale up
- Mixing and processing of solids
Bio Process Engineering
- Process engineering for sterile, aseptic and clean pharmaceutical/biotech processes including process scale up
- Small scale manufacturing using plastic disposables for clinical materials
- Bacterial fermentation and mammalian cell culture processing
- Materials of construction compatibility
- Expertise in SIP/CIP design, integration and operation
- Sterile and aseptic filling
- Bio-safety containment specifications for clean processing spaces
Technical Studies and Audits
- Technical feasibility studies and reports
- Process and process equipment trouble shooting and diagnostic reviews
- Process scheduling and efficiency studies
- Conceptual design studies for budget cost estimations
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Design Engineering
- Design, analysis and support for WFI, PW, Clean Steam, Medical Gas, Decontamination and Waste Neutralization systems
- Design specifications and drawings for process equipment and clean utilities installations
- Commissioning of new process and utility systems
- Process audits and "record" drawing and document preparation for existing systems
- Bio-safety Level 1 to 3 clean containment areas
Project Management
- Budget cost estimating of new work
- Project scheduling
- Management of contractors
- Training and mentoring of staff
Regulatory Compliance Engineering
- Validation of cGMP process and utility systems
- Health Canada and CFIA bio-safety level compliance
- Preparation of Standard Operating Procedures and Batch Production Records
- Preparation of URS, FS, FAT, SAT, IQ, OQ and PQ protocols
- Execution of validation protocols
- Pre-Start Health and Safety Reviews
- Hazard and Operability Studies
Electronic Documents are provided in the following formats:
- Drawings in AutoCAD
- Documents in Microsoft Word, Excel and Project
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