The Manufacturing Facility
A new facility belonging to Bio-Concept Laboratories, Inc. of 13 Industrial Way in Salem, NH illustrates how successful design can be coupled with quality construction to produce, what is perhaps, one of the best Ophthalmic Research facilities in North America.
The facility is designed to meet FDA CGMP and EU requirements for Phase I/II/III with commercial quality standards. All personnel and material handling has been designed for efficiency of movement and safety. The special design features incorporated into this new facility include a Class A filling room with an adjacent Class B preparation room, an adjacent Class B compounding room, and integrated with a Class C production corridor.
The Class B Preparation room is fitted with a double door autoclave, depyogenation oven and pass-through to the Class A filling suite. It also contains an automated glassware washer, vial washer and custom-made plastic bottle cleaner. The Class B compounding contains the PLC controlled utilities of temperature regulated WFI, pure steam, and inert gases. A Building Management System controls and monitors all aspects of the facility including the air handlers, room temperature, room humidity, room pressurization, pure steam, WFI with an 80°C loop, and a diesel powered backup power supply. The Class A sterile filling suite contains an custom designed and built automated filling machine. This machine is capable of filling standard and unique 1 mL to 30 mL plastic bottles, tips and caps. Each bottle fill weight is verified, can be blanketed with an inert gas, and capped at a torque specific for the container and cap.
Bio-Concept Laboratories, Inc. has a history of very high yields even with a low amount of API material, without compromising quality. This new facility is designed to further enhance those results.
The Clinical Manufacturing Process
Integrating a developmental formulation into a sterile batch for clinical use presents challenges not often encountered with commercial manufacturing. It is necessary to take into account the compounding sequences, product’s sensitivities, equipment capabilities, and regulatory requirements. Often limited information, API and time is available during the early stages. One must rely on experience and expertise to fill in the gaps. Later stage clinical batches benefit from proper process development studies. In all cases the quality and safety of the product must be maintained.
Batch Documentation: The master batch record precisely outlines all the steps needed to manufacture your product for clinical use. As part of our Clinical Manufacturing Program, Bio-Concept creates a comprehensive master batch record suitable for all clinical needs and FDA approval.
Configurations: Bio-Concept has the flexibility to work with many different types of configurations. Common ranges include: Aqueous fills (liquids, suspensions, gels) Plastic bottles with tips and caps Glass serum vials Volumes from 0.5 mL to 30 mL Sterilization – filtration, bulk solution autoclave, split-phase Batch size of 2,000 units (ask for larger batch sizes)
