Biopharmaceuticals are medical drugs that are produced using biotechnology. They are drugs that are produced by means other than direct extraction from a native (non-engineered) biological source. They are typically manufactured in a clean room environment with set standards for the amount of airborne particles. Our sophisticated installation of complex HVAC systems use hepa filters to keep the smallest particles out of the area. The only way to construct these manufacturing facilities is by building clean. Building clean means to be aware of what you take into the area and keeping contaminants out of the process areas. Typical installation of high purity systems require that the tube and fittings come pre-bagged and then welded using a high purity automatic welder. The welds are fusion welded with a smooth finish so that material doesn’t get caught in the pipe and grows into “bugs” in the system. All the tube and fitting connections must meet the BPE standard. This standard establishes critical requirements for the tube and fittings and ensures that all tube, fittings, ID's and OD's will match with no defects. The intent of the BPE standard is to be sure that systems stay as clean and pure as possible. BMWC's constructability expertise in these areas delivers facilities that stay clean and are not dust collecting.
Our experience includes mechanical construction work for Biotech firms since the 1950s. We also provide conceptual design input, budget estimates, and realistic schedules for customers to confidently obtain project financing. We know that equally important as the work itself is the audit trail and validation document support required by the FDA (i.e. installation, operation, and performance qualification). Thus our projects are reliably performed without costly rework or regulatory shortcomings.
We regularly provide project design input to ensure our biotech work meets both current and future customer needs. Furthermore, we manufacture custom process skid assemblies and provide local passivation services.
Biotechnology/Pharmaceutical Technical Capabilities:
- cGMP manufacturing facilities (including validated plants)
- Pilot plants
- Fermentation systems
- Ultra-high purity piping
- Equipment installations (i.e. bioreactors)
- Water-for-injection systems
- Waste-kill systems
- RO/DI water system installation/service
- Clean steam systems
- SIP/CIP systems
- Videoscope inspections
- Skid fabrications
- Medical gas systems
- Validation documentation support
- ASME coded tank repairs
- Instrumentation and controls