In the pharmaceutical industry, there are strict procedures for the acquisition of data and the testing and qualifying of automated systems, e.g. software documentation, access control, proof testing, power outages etc., due to requirements from health and medicines authorities. An example of this is the FDA’s CFR §21 part 11 on the security and integrity of data. When monitoring a production facility, it is imperative that you, at all times, are able to document that the established process parameters are being adhered to and that data is collected and stored reliably and safely to prevent the possibility of tampering.
Ramboll has extensive experience with consulting and designing pharmaceutical facilities and equipment. Furthermore we are well versed in current regulations on quality and documentation for both European (EMA) and US facilities (FDA). For instance, Ramboll adheres to the ISPE GAMP 5 guideline for planning and executing projects in the pharmaceutical industry. Frequently in the pharmaceutical industry, there are separate systems used for monitoring (CMT or BMS) and data acquisition (FMS, SCADA or similar). Apart from these our electricity specialists can design several other systems, including:
- Automated fire alarm systems
- Automated gas alarm systems
- Automated access control systems
- Automated video surveillance
When dealing with electrical installations in the pharmaceutical industry you often come across specific requirements.
- ATEX: Ramboll has a group of experts that can perform risk assessment of fire and explosion risks and design facilities that adhere to the ATEX directive.
- EMC: Electrical installations form magnetic fields that can potentially influence data acquisition, so it is imperative that the demands for proper shielding are met.
- CE marking: Typically manufacturers are obliged to use CE marking, but in order to follow the correct guidelines you need to be familiar with the proper standards and regulations so the client can be sure that the CE marking is performed correctly.
We also design traditional electrical power installations, such as:
- Power supply (transformer stations, main power supply, electrical panels, etc.)
- Emergency power supply (UPS, generator, etc.)
- Lighting (office, production, etc.)