The process at the Bio Products Laboratory starts with the loading of blood plasma into mixing vessels, where ethanol and buffers are added as part of the separation process
Haden Freeman (HFL) - an independent engineering and consultancy company - has recently completed a project on behalf of Bio Products Laboratory to upgrade and validate the critical blood plasma process control system for compliance with 21CFR part 11 legislation, improving productivity and ensuring future proofing.
Safety and elimination of the lost opportunity cost incurred by a process failure were cited early in the project brief as being of paramount importance in work undertaken by HFL.
The use of ethanol in the process area is hazardous, meaning equipment used had to be intrinsically safe.
Haden Freeman installed equipment that enables the entire process to be monitored and controlled using just two pairs of Telemecanique Modicon Quantum PLCs linked to 1400 I/O distributed around the plant's various processes.
Process parameters such as temperature, flow, conductivity and level are all monitored and controlled by the new system as well as the clean in place (CIP) system, which is also fully integrated.
HFL configured an interface for use by operators using Monitor Pro Scada software from Telemecanique.
This system displays all the functions of the process via a graphical interface running on a standard PC and allows parameters to be set on the keyboard.
The Scada system incorporates a secure SQL - server database that has been designed to comply with the FDA 21 CFR 11 legislation that applies to electronic records and signatures to provide full traceability.
With this, HFL created a log of all the rules under the new legislation and a record of what has been done in the system to comply.
To complete the system change-over during the planned maintenance shutdown, extensive pre-shutdown installation and verification activities were executed while still in production.
Stuart Dow, systems development manager, HFL, said: "We have a successful track record in implementing and managing control system replacements, including validating pharmaceutical applications such as the Bio Products Laboratory.
"Specialist planning allowed much of the work to be done prior to switching over to the new equipment, meaning the shutdown time and possibility of lost revenue was effectively minimised.
Robert Castle, project manager, Bio Products Laboratory, remarked: "We have enjoyed an excellent working relationship with Haden Freeman.
"Problems were identified early and resolved quickly.
"Our contract with HFL has meant that we are now able to reap the business benefits associated with improved control performance while complying with industry legislation".