ITS Conducts a Major Validation Programme at Becton Dickinson, Swindon
Becton Dickinson (BD), Swindon is manufacturing medical devices with documented confidence thanks to Industrial Technology Systems Ltd (ITS). Due to the ever increasing level of regulation from external bodies in the devices and pharmaceutical industries, the most stringent being Food and Drug Administration (FDA) and Good Automation Manufacturing Practice (GAMP®), manufacturing companies are required to prove ‘evidence of operation’ of their systems. These regulations demand high levels of quality assurance and accountability to certify that they are manufacturing exactly what they are required to.
ITS was selected to validate a significant proportion of the process equipments used at the BD manufacturing operation at Swindon. An initial audit established the relevant systems and processes that BD implement and use. Individual validation studies were then carried out to a validation plan on these systems following stringent ITS Validation Models. These studies included formal definitions of function, examination of existing documentation, interviews with BD staff, vendor audits, standard setting and testing.
The purpose of validation testing is to provide documented evidence that a system has done, and/or will do, reliably and consistently, what it purports to do. However, ITS aims to provide not only the required paperwork for ‘evidence of operation’ but also real business benefits to its customer’s business. To which end a comprehensive and stringent program of interim testing is carried out, which enables BD to be permanently aware of the status of its systems and so negate the need for further retrospective validation.
By investing in ITS’ expertise BD has benefited in the following ways.
- Assurance that their systems will operate correctly when used
- Confidence of compliance with Food and Drug Administration
- Confidence of compliance with Good Automation Manufacturing Procedures
- Improved quality and throughput of end products
BD manufactures a range of medical devices including moulding plastic components, and assembles them. The identity, sterility, integrity and efficiency of the devices is vital for regulatory compliance, without which BD could not trade. Program controlled equipment, ranging from complex automated assembly machines to office computers performing quality control functions, are used throughout the manufacturing process in ways that will affect the compliance of end products.
Validation was carried out by ITS on behalf of BD on all applicable hardware and software components, including the Mitutoyo Quick Vision Coordinates Measuring Machine. The Miyutoyo Coordinates Measuring Machine allows fast, accurate and repeatable measurement of small components used to assemble medical devices, resulting in controlled inspection with reduced variables and improved efficiency. This machine is programmable and, hence, its computing elements required validation.
ITS validated BD’s moulding machines and the MC4 Controller manufactured in Germany. The control unit controls the variables of pressure, speed, time and temperature within predefined limits and will initiate an alarm, or an automatic stop to the operation, if any critical limits are exceeded.
The validation of BD’s Colortronic masterbatch dispensers, designed for small to medium-sized injection moulding machines, was carried out by ITS’ experienced validation team. The dispensers were purchased by Becton Dickinson to maintain consistent pigment dosing and dispersion.
ATEQ F Leak Test Instruments were purchased by BD to enable the engineers to conduct effective leak tests of assembled products on the production lines. Control of the tightness of assembled components is critical to the fitness of the products from a regulatory viewpoint, and it was critical that the project was carried out carefully, accurately and consistently. The control system required ITS’ computer validation service for the automated aspects of the process. The main objective for ITS was to validate, to ensure that the products would be manufactured within defined specifications.
Validation was carried out on the hardware and software components of the NPE SPC system at BD. The NPE SPC System collects data from moulding machines within the Moulding Shop Clean room, and provides access to specific moulding machine process data via a host computer, in conjunction with a series of networked Data Acquisition Units (DAUs) and computer workstations.
ITS was responsible for validating the Pressflow Pacer 2000 MNC Robot System, which is utilised for the collection of small components from the injection moulding process. This is not a dedicated tool, as different tool heads and stroke lengths can be used, in order for the Robot System to be utilised for a variety of components.
ITS provided its expertise to validate the KTP Label Printing System, which once installed, was used to print on a single side of labels for a variety of products manufactured by BD. The specification provided by ITS, upon approval, had precedence over all other previous documents and agreements, detailing the system to be delivered. The KTP Label Printing System was installed by KTP Ltd. in the primary packing area at BD, Swindon.
ITS’ staff upgraded and revalidated a Verepa form fill-seal packaging line control system. The project involved replacing the old PLC control system with a modern Siemens PLC system which could affect the quality of the final product. As the process is fully automated, the control system is critical to the suitability of the final product and therefore requires computer validation. The validation plan focussed primarily on the Programmable Logic Controller (PLC) control system of the Verepa machines in packaging components.
Automatic inspection systems are integral to the production of medical devices for BD. Products are packaged and sealed in the assembly area of the Swindon works. Inspection of the kits at one point in their production is a critical quality assurance step, and therefore the equipment that performs this inspection is the subject of this validation project. ITS was involved in the validation of the inspection system.
ISPE owns the GAMP® trademark http://www.ispe.org/
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