Good quality must be built in during the Manufacturing process; it cannot be tested into the product afterwards.
Connor Engineering Solutions specializes in services that insure pharmaceutical systems are designed, installed, calibrated, and documented with the kind of quality required in such a critical industry. These services include:
- System validation
- Calibration and testing
- Commissioning plan development and execution
- Program development
- Modular process system design
- GMP compliance
Modular Process Systems provide several advantages over traditional on-site fabrication and controls integration.
There is considerable interest in modular systems within the pharmaceutical industry. This interest has grown for several reasons that include:
- Shorter schedules, since activities such as obtaining the necessary permits and preparing the site can be completed concurrently with the design and fabrication of the process system.
- A controlled environment for the fabrication and allows proven technology and reliable equipment to be utilized.
- Quick installation of the modular unit, so that interruptions in production at the customer’s site are minimized.
- Pre-assembled at the vendor’s facilities and fully tested, making it “ready to run” immediately after it has been installed.
- The overall result is that the modular unit costs significantly less than that fabricated (partially or totally) and installed at the particular site.
FDA (U.S. Food and Drug Administration) regulatory requirements include GMP (Good Manufacturing Practice) and QSR (Quality Systems Regulations).
Current Good Manufacturing Practice (GMP) compliance issues in design of pharmaceutical and biopharmaceutical facilities relate to process flow, material flow, and people flow as well as A&E mechanical, industrial, HVAC, automation, electrical, and computer. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.
We have considerable experience in the validation of process utility and control systems.
Systems that have been validated give a high degree of assurance that the system will do what it is intended to do. This is accomplished through the development of effective written procedures and then documenting results throughout the validation process. Systems that CES has experience with and recommends be validated include:
- USP Water
- USP Compressed Air
- PLC and HMI Systems
- DCS Systems
- DDC Controls
- HVAC Systems including Desiccant Dehumidification
- Fluid Bed Dryers
- Chilled Water Systems
- Dust Collection Systems
- Autoclaves and Sterilizers
- Walk-in Refrigerators and Freezers
- Ultralow Freezers
- Sterile Filling Lines
Some of our experiences in this area are given below:
Oral Solid Dosage Facility Renovation - Élan Pharmaceutical Technologies, Gainesville, Georgia - Technical and Program Management of Engineering Design and Construction. Areas included:
- 10,000 GSF of GMP Space in 107 days
- (3) Glatt Fluid Bed Dryers
- V-Cone Blender
- USP Water System
- USP Compressed Air System
- 15,000 HEPA filter and Desiccant Dehumidification System
- Mechanical, electrical and control interface design
- Explosion Proof Construction
Clinical Laboratory Facility - Serologicals, Clarkston Georgia - Technical and Program Management of Engineering Design and Construction. Areas included:
- Fibrin Free Plasma Production Facility
- Class 100,000 Clean Room for Manufacturing
- Walk-in Freezers and Refrigerators
- Ultralow Freezers
Facility Maintenance and Calibration Support - Bayer, Clayton, North Carolina.
- (4) Calumatic Prototype Sterile Liquid Filling Lines
- Sterilizing Tunnels
- (2) Gettinge Pure Steam Generators
- Fillers, Stopper Delivery and Over Sealers
- (3) Allpax Pasteurizers with Auto loader/unloader Systems
- (3) Serial Lyophilizers
- MetOne Particulate Monitoring System
- Allen Bradley PLC/5 Control System
- Instrumentation and Standard Calibration Procedures for all above listed systems
Facility Calibration Services - Ethicon Endo-Surgery, Cincinnati, Ohio.