Capabilities
We deliver a tailored facilities management program allowing your team to focus on developing robust manufacturing and quality processes while retaining full control of your intellectual property. Our experts handle the complexities of managing ISO-compliant cleanrooms and facility infrastructures, saving you time, labor, and the extensive costs associated with facility development and validation. Our turnkey solution lets you concentrate fully on developing, improving, and running your manufacturing processes and programs. Our production environments, co-located with your critical process development and research functions, support small-batch manufacturing as well as larger processes with a capacity of up to 500 liters.
We manage every aspect of your cleanroom environment, including cleaning and disinfection, environmental monitoring, and utility maintenance for the classified space. Our services include modifying or retrofitting the cleanroom environment according to your specifications, within the existing real estate. Our services are outlined below.
Dedicated manufacturing core and supporting spaces
- ISO 7 compliant cleanroom for manufacturing
- Classified corridors and support areas
- Controlled rooms for ambient and temperature-controlled materials
- Dedicated utility systems
Tailored cGMP programs for facility and cleanroom management
- Cleanroom ISO-14644 certification
- Commissioning, qualification, and validation (CQV)
- Process gas supply and monitoring
- Building systems and utilities validation
- Critical utility maintenance
- Cleaning and disinfection
- Contamination control
- HVAC preventive maintenance
- Environmental monitoring (routine and in-operation)
- Environment, health, and safety
- Waste management (hazardous and non-hazardous)
- Stocking of PPE and cleaning reagents
- Cleanroom & aseptic training
Material program support
- Receipt and quarantine of materials
- Controlled storage
- Tracking and distribution
- Material cleaning and transfer
- Sample management
Quality program support
- Investigation and corrective and preventive actions (CAPA)
- Change management
- Risk management
- Audit readiness and compliance monitoring
- Permitting and regulatory compliance
