Pharma Solutions LTD provide a full range of engineering services for pharmaceutical facilities including the development of conceptual, basic and detailed engineering. Pharmaceutical engineering includes all parts of drug manufacturing, from designing a new facility to optimizing existing facility and manufacturing processes.
Project Initiation Phase
The key to a successful pharma engineering project begins in the initial phases. Initial phases include defining the business case, project goals, risks, compliance requirements, technology strategy, capacity, and investments. The requirements for the engineering project should be defined in this phase.
We support your business by helping you meet goals, minimizing risk, identifying opportunities for innovation that provide the foundation for the success of a project. We do this through pharma consultancy services within:
The stage is performed on the basis of user requirement and best practice approach.
Conceptual design includes a layout and solutions for purified water, water for injection, pure steam and compressed air.
A core element of the conceptual design is ensuring efficient logistics at the site.
Developed conceptual design will be the basis for the detailed engineering and will allow to evaluate investments for a project. We provide conceptual solutions for HVAC system, heating system, chilled water system. It allows to evaluate energy consumption and operation costs. This data can be a basis for a business plan development.
We carry out engineering of:
- Pharmaceutical warehouses
- Drug manufacturing
- Production of APIs
- Quality control laboratories
The following categories are taken into account:
✔ local environmental considerations
✔ suitability/acceptability of physical segregation of processes for manufacturing and holding products
✔ the overall layout of the facility
✔ assessment of the environmental classification of the various areas against the level of quality required by the product
✔ airflow regime (turbulent or laminar)
✔ air pressure differentials between areas
✔ humidity, etc.
✔ assessment of the proposed water quality against the level of quality required by the product
✔ Restricted-access barrier system (RABS) and containment technologies
✔ materials of construction (piping, gaskets, valve diaphragms)
✔ internal surface finishes (electropolishing, passivation)
✔ water pre-treatment and control
✔ key design considerations (flow rates, minimum deadlegs with no cavities, vents, drainage air gaps)
✔ use of security devices
✔ instrumentation and control of critical process parameters
✔ clothing requirements
✔ changing rooms
✔ security and access control
✔ general flow of materials through the area (linear flow through with no cross-over of production streams)
✔ methods of prevention of cross-contamination
✔ frequency of movements and available space
✔ materials of construction and surface finishes of primary and secondary contact parts (i.e. primary direct product contact; secondary – contact with local environment)
✔ equipment size
✔ control of critical process parameters
✔ methods of cleaning and sanitization
Engineering in accordance with the GxP requirements
The pharmaceutical industry is known by strict requirements for good manufacturing practice (GMP). We ensure the development of a design documentation in accordance with the GMP and local requirements. For a successful project execution, it`s necessary to implement GMP requirements, risk-based and best practice approaches in the following stages:
- conceptual design
- basic design
- detailed design
- qualification and validation