Pharmaceutical BMS & HVAC

Sirus is the preferred provider of BMS and QBMS services for many of pharmaceutical plants in Ireland. Our HVAC and automation engineers have both site and design experience in a wide range of BMS and optimisation projects across pharmaceutical and biotech facilities.

Some of our Pharmaceutical Sector Clients

Pharma Facility Management

Optimum environmental conditions are critical to ensuring the manufacture of quality pharmaceutical products as well as providing a comfortable work environment for operators.

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.

We deliver projects to GAMP standards and have experience with Qualified Building Management Systems (QBMS) and non-Qualified Building Management Systems (nQBMS).

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:

HVAC
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

HVAC Validation

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

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

I can’t recommend Sirus highly enough. They were awarded the second phase contract based on their performance during the first phase. This is a significant testimonial to their collaborative and effective approach.

Dermot Mackle

Automation Engineer, Sanofi (formerly Genzyme)