Past Projects

Retrofit Projects

+- Process

  1. Chlorinated solvent delivery system improvements
  2. Chlorinated solvent recovery system improvements
  3. Cleaning chemical storage and delivery system
  4. Risk assessment (FMECA) for potent compound handling
  5. Oil blending system debottlenecking

+- Clean Utilities and Validation

  1. Various PW pretreatment dechlorination upgrades
  2. Various hot water sanitized RO upgrades and troubleshooting
  3. Custom engineered RO replacement
  4. Various ozonated PW distribution system troubleshooting and modifications
  5. Point of use additions / loop extensions
  6. Clean steam expansions
  7. Multiple clean steam generator integration
  8. POU interconnecting piping remediation
  9. Clean compressed air system improvements (driers and instrumentation addition and upgrade)
  10. Clean compressed air system validation
  11. Thermal validation

Greenfield / New Build Projects

+- Flexible Pharmaceutical Compounding CIP System

The implementation of a highly flexible CIP system, including transfer lines, transfer panels, and return pump.  The target equipment was a set of compounding tanks and transfer pumps and lines used to compound a variety of liquid pharmaceutical preparations of various properties.  Key flexible features:

  • On board neutralization of CIP solutions
  • Recovery of rinse and cleaning solutions for potent formulations
  • Flexibility to clean difficult to clean suspensions and easy to clean solutions
  • Electronic batch records

Cheme Responsibilities

Design, Drawings Specifications
Project Management
Commissioning

+- Freeze Drier Installation

The installation of a freeze drier in a biologics plant for the lyophilization of the sterile finished product. Cheme designed, managed the construction of, a freeze drier for the processing of sterile biologic products.

The scope included engineering of all support utilities required for the freeze drier including compressed air, liquid nitrogen, clean steam and other gray utilities.  The piece of equipment was imported from China and all dimensional and installation co-ordination for the unit was carried out by Cheme.

Cheme Responsibilities

Design, Drawings Specifications
Project Management
(C&Q by Owner)

+- Mobile Compounding and Sterile Filtration Skid

A fully customized compounding and sterile filtration system.  Key features and project challenges:

  • Mobility of equipment
  • Flammable product
  • Aseptic connections
  • Manual operation
  • Compounding tank required to dock with existing isolator for compounding of potent ingredients
  • Reuse of existing components to accelerate schedule

Cheme Responsibilities

Design, Drawings Specifications
Project Management
Training, SOP and other operating documents preparation
Commissioning
Validation

+- Small Volume USP Clean Steam and WFI System

A small volume high potency facility required a clean steam and WFI systems on a very tight schedule.  A used clean steam generator was rehabilitated for clean steam production and the WFI was generated by clean steam condensing.

Project highlights:

  • Automated POU coolers
  • Tight schedule
  • Tight budget

Cheme Responsibilities

Design, Drawings Specifications
Project Management
Training
Commissioning
Validation

+- Blood Plasma Fractionation Process

A blood plasma fractionation process was installed at a contract manufacturing facility.  Cheme acted as the Owners engineering representative throughout the project.

Cheme Responsibilities

Technology transfer
Design review
Commissioning and Validation of 3 units