Engineering

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:

 

Conceptual engineering
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:

Facilities

 local environmental considerations

 suitability/acceptability of physical segregation of processes for manufacturing and holding products

 the overall layout of the facility

Environment

 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.

Utilities

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

Personnel flows

 clothing requirements

 changing rooms

 security and access control

Material Flows

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

Equipment Design

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

maintenance

Computerized systems

Maintenance and services

 

 

 

 

 

 

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