Providing comprehensive GMP and BSL 3 expertise to support the construction, validation and commissioning of a new pharmaceutical manufacturing facility.
Zeus Tech contributed to the development of a new pharmaceutical plant requiring biosafety level 3 controls. The project involved extensive commissioning and qualification activities to ensure that the facility, its cleanrooms and utility systems met both GMP and BSL requirements. Zeus Tech supported the project throughout planning, construction and final validation, working closely with designers, contractors and construction management.
The wide scope of services ensured that the facility reached full compliance and operational readiness for regulated pharmaceutical production in a high-containment environment.
Supporting design and planning with GMP and BSL expertise
Zeus Tech participated in preparing the User Requirements Specification for the cleanroom areas and supported planners by providing specialist knowledge related to GMP and BSL 3 operations. The company also prepared a detailed technical risk assessment to identify and mitigate potential hazards associated with high-containment pharmaceutical manufacturing.
Early involvement helped ensure that the design, material choices, utilities and workflows aligned with regulatory expectations and safety standards.
Commissioning and qualification activities throughout construction
The project required extensive commissioning and qualification steps to verify that systems, equipment and cleanroom environments performed according to defined requirements. Zeus Tech’s responsibilities included:
- preparing the Validation Master Plan
- developing validation protocols for design, installation, operational and performance qualification
- supervising GMP and BSL 3 requirements during construction
- supporting contractors and planners to ensure regulatory alignment
- inspecting validation work for clean utility systems such as purified water, HVAC, pressure cascades and related infrastructure
This continuous oversight strengthened the quality and reliability of commissioning activities.
Ensuring compliance and operational readiness
As construction progressed, Zeus Tech provided hands-on supervision to ensure that GMP and biosafety requirements were followed consistently. After equipment and systems were installed, the company managed each qualification phase and coordinated documentation to secure a complete validation trail.
Final tasks included preparing the facility validation report and participating in the development of the Validation Master Report. These documents demonstrate that all critical systems function as intended and that the facility is ready for regulated pharmaceutical production.
Comprehensive support for a high-containment environment
The project benefited from Zeus Tech’s ability to combine BSL 3 expertise with deep knowledge of GMP processes. The company’s involvement supported:
- safe and compliant facility design
- structured commissioning and qualification
- accurate validation documentation
- smooth cooperation between construction, design and quality teams
- a predictable path to facility approval and start-up
This integrated approach strengthened both safety and long-term maintainability of the new manufacturing environment.
Project in numbers:
- Country: Finland
- Facility type: pharmaceutical plant with BSL 3 requirements
- Scope: C and Q activities, GMP and BSL supervision
- Key tasks: URS, risk assessment, VMP, validation protocols, DQ IQ OQ PQ, utility system inspections
- Outcome: validated, compliant and operationally ready facility
ASC partner working for this project
- Zeus Tech – GMP and BSL expertise, commissioning and qualification for controlled pharmaceutical environments.
Contact
Matti Heino
Technical Manager
Zeus Tech
Phone +358 40 570 3520
E-mail: matti.heino@zeus.fi
Website: https://zeus.fi/en/home/