Some of our Pharmaceutical Sector Clients
Pharma Facility Management
The correct temperature, relative humidity and ventilation need to be maintained to ensure the quality of pharmaceutical products during their manufacture and storage.
Sirus has delivered large and complex BMS projects in the Life Sciences sector over the last 20 years. Clients include Bristol-Myers Squibb, Regeneron, Bausch and Lomb, Sanofi, MSD, Mylan and Amgen.
BMS for Pharmaceutical Plants
Sirus’ comprehensive solution for the pharmaceutical industry enables you to protect people, assets and business processes, and through integrated solutions increase efficiency over your building’s entire life cycle.
We can facilitate the initial requirements, risk assessment and project scope development to determine what needs to be completed and also deliver the capital equipment changes.
Support & Expertise
We provide support and expertise from planning to commissioning and through the life cycle of the pharmaceutical plant.
Our experience in managing large pharmaceutical projects has helped us to develop standards for project execution.
We can assist with FDA 21 CFR Part 11 compliance of your facility. In order to satisfy the regulatory requirements of the pharmaceutical industry, we provide documentation from project management up to test execution. This helps meet the requirements of the FDA, the EMEA and other regulatory bodies.
Test & Balancing
Sirus has extensive expertise in Test & Balancing and Commissioning of new facilities, HVAC Validation and Qualification of Cleanrooms.
All testing can be carried out to international standards, Sirus’ Standard Operating Procedures (SOP’s) or Client SOP’s and will be documented accordingly.
Utilities and Facility Systems:
- Industrial Ventilation
- Low-Pressure Hot Water Systems
- Chilled Water Systems
- Water Balancing
- Cleanroom Class 100 – 10,000 – 100,000
- Airflow Studies
- F-Gas Management and Recovery
- Building Management System (BMS)
- Process Monitoring
Sirus understands HVAC Validation requirements and industry-standard validation practices. We will assist you in developing a strategy that ensures the success of your validation:
- Develop and execute the validation in accordance with the principles outlined in the ISPE Baseline Pharmaceutical Guide for Commissioning and Qualification and the GAMP 4 Guide.
- Properly apply the requirements of ISO 14644 and any other applicable standards.
- Ensure that qualified Cleanroom Testers and calibrated measurement equipment are used.
- Provide full documentation services.
- Provide Qualification or Validation of Building Management Systems that are connected to the HVAC Systems.
Cleanroom Qualification can include:
- HVAC Start-up Operation Test
- Clean Room HEPA Filter Leak Testing
- Bio-Safety Cabinet Operation Test
- Cleanroom Temperature Test
- Cleanroom Humidity Test
- Cleanroom Ventilation Rate Test
- Cleanroom Pressurisation Test
- Cleanroom Non-Viable Particle Count Test
- Cleanroom Viable Particle Count Test
- Cleanroom Uneventful Operational Test
- Cleanroom Eventful Operational Test
Pharmaceutical BMS Case Studies
Let’s talk about your project!