Product category:
Calibration and Testing Services, Consultancy and Learning
News Release from: Haden Freeman | Subject: Bio Products Laboratory
Edited by the Manufacturingtalk Editorial
Team on 07 February 2006
Critical blood plasma process control
system
Haden Freeman (HFL) has 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.
Haden Freeman (HFL) - a leading 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
This article was originally published on Manufacturingtalk on 9 Apr 2002 at 8.00am (UK)
Related stories
Fast and accurate NDT speeds production lines
The constant demand from customers for 'best quality', combined with the increasingly competitive nature of the marketplace, has accelerated the development of test methods.
Textile materials testing service expanded
A greater range of textiles testing services are now available from a UK test house following an investment programme that included the purchase of a new Tinius Olsen H5KS testing machine.
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.
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.
Further reading
Measurement of hardness is consistent on cutters
The adoption of the Rockwell test has enhanced both accuracy and scope of hardness testing for Britain's leading manufacturer of commercial grass and hedge cutting equipment.
Robotic hardness tester installed in Spanish mill
Believed to be the first robotic digital Vickers hardness testing machine, it has been installed in a Spanish stainless steel mill for checking prepared stainless steel specimens.
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 whilst complying with industry legislation".
• Haden Freeman: contact details and other news
• Email this article to a colleague
• Register for the free Manufacturingtalk email newsletter
• Manufacturingtalk Home Page
Search the Pro-Talk network of sites
