Since 1989, HealthChem, Inc. has been providing quality contract project services for high-tech industry nationwide.  
 
BioPharmaceutical Manufacturing Services infoform.htmindex.html

HealthChem is fully qualified to specify, design, build, install and validate turn-key process and utility systems. We work closely with your personnel to assure that user requirements are met, and the system is fabricated in accordance with cGMP. We base our design specifications on currently accepted systems and using ISPE guidelines. Our team of designers, fabricators and installers will report on project status to assure that the work is completed on schedule and on budget.

 

Overview and Rationale for Process Equipment Services

All biopharmaceutical products are manufactured in a regulated environment to ensure the quality and safety of these substances. Biopharmaceutical facilities are licensed to manufacture a specific product and are inspected by regulatory agencies such as : FDA - CBER Division, European Agency for the Evaluation of Medicinal Products (EMEA), and the Medicines Control Agency (MCA) in the UK. These agencies provide a framework for process equipment GMP requirements. Process equipment suppliers also offer specific design features to optimize operation, cleaning and maintenance of integral production modules.

We develop design specifications for biological process equipment including process requirements and functional requirements to define instrumentation and controls, and for interfacing with facility utility systems. Process and facility validation requirements for the process modules are related to their ultimate use. Finally the process unit modules must operate and perform as an integrated production train within the existing or upgraded facility, while being maintained and monitored in a cost-effective manner.

 

Conceptualization - From the Bench to Process Development

HealthChem can develop the process requirements in conjunction with your process scientists and engineers. Then we obtain input from operations, maintenance and QC to prepare Functional Requirement documents. We work with your staff to evaluate the following factors:

  • R&D Lab Result Reports
  • Technology Transfer
  • Production Schedule/Market Commitments
  • Validation Considerations for Test and Clinical Production Equipment
  • Process Scale-Up

And we can perform the following tasks:

  • PFD Development and Yield Estimates
  • Process Equipment Sizing and Selection
  • Pilot Tests
  • Prepare facility and existing support skids for clinical and marketed production
  • Select Batch or Automated Instrumentation and Controls
  • Prepare Process and Functional Requirements

BioPharm Process Skids

Using engineering drawings and specifications to assure process and functional requirements are met , HealthChem's designers and associated fabricators build and install:

  • Bioreactors and Fermenters
  • Cell Harvest - Filter or Centrifuge
  • Chromatography Pump and Instrumentation systems
  • Gradient and other buffer feed systems
  • Diafiltration/Concentration
  • Viral Clearance systems

Each system includes associated instrumentation such as flow, temperature, pressure, on-line analytical, etc. with:

  • Manual operation and batch record keeping or automated control with data logging
  • Validation Documentation
  • Factory Acceptance Testing (FAT) Documents
  • Turnover Package (TOP)
 
Reference Projects
Bayer Corporation, Berkeley, CA

HealthChem prepared Preventive Maintenance Procedures for cell separation, ultrafitration tank and cassette skids for rFVIII production. In association with AflaTech, HCO prepared ECO procedures for validation protocols for Pure Steam/WFI Generation, CIP, CDA and N2 systems.

AlfaTech Engineers, San Francisco, CA
In association with AlfaTech, HealthChem provided process engineering services for selection and pricing of cell culture and purification equipment for recombinant biotech production
ACCO Process for Point Biomedical, San Carlos, CA

In association with Acco Proceess, HealthChem prepared validation protocols for Pure Steam/WFI Generation, CIP, CDA and N2 systems.

Genentech, S. San Francisco, CA

Bob O'Dell supervised process engineering and construction personnel to produce five (5) clinical products including NGF, IDEC-C2B8 (Rituxin), and HER2 (Herceptin). Also prepared Engineering Change Requests for installation of chromatography and filtration skids, transfer panels, utility, and CIP mechanical and control systems.

Managed a team of four validation engineers/specialists for the expansion of Genentech's tPA 1.1 manufacturing process, including automated chromatography and ultrafiltration skids, agitated tanks, and piping systems. This effort included completion of Engineering Change Control and validation documents.

 

Bayer, Berkeley, CA

Bob O'Dell and Waymond Ho performed plant engineering at for pharmaceutical development and production facilities. Projects included design engineering and construction management for media production, WFI, clean steam, high-purity compressed air, and gas systems.

Genetics Institute, Andover, MA

Bob O'Dell performed process equipment design, fabrication, start-up, and validation of clinical production systems for rh-BMP growth factor, including cell harvest, chromatography, and diafiltration/concentration skids.

Allergan, Campbell, CA

Bob O'Dell performed process engineering for Botox manufacturing facility including design and equipment specifications for plant and clean steam systems, HWFI and AWFI production, storage and distribution system, and CDA and N2 supply systems.

Chiron, Emeryville, CA

Bob O'Dell designed and specified various USP water systems, including RO unit, ultrafiltration, deionizers, and UV sterilizers. Performed a study of Diagnostic USP water supply system, including usage and quality issues.

Control System and Validation Projects

Bob O'Dell prepared OQ documents for automated Amicon chromatography system at Amgen in Thousand Oaks. Control system included an A-B PLC-5 with Wonderware HMI. Validated monitoring and alarm functions.

Performed numerous HVAC IOQ and Control System validation projects for Baxter Healthcare, Los Angeles, CA. PLC-based HVAC control system includes monitoring, control and alarm functions.

Prepared and executed validation protocols, and SOPs for Alza's PA-11 Aseptic Manufacturing Facility. Responsibilities included clean area HVAC systems, HVAC control system, CDA and nitrogen systems and overall facility qualification. Also prepared SOPs for RO/DI and WFI systems.

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