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Unpacking the complexities
The larger pharmaceutical and medical device manufacturing
companies are increasingly realising that by developing
novel drug delivery mechanisms, the life of a drug can be
significantly extended. This, combined with the development
of other complex medical devices requiring volume-production
methods, has led to an increase in the use of combined assembly
and testing systems. These systems integrate the use of
assembly processes with sophisticated testing procedures
that require specialist automated assembly and data handling.
This article outlines the key issues to address when sourcing
this equipment.
Capturing
the requirements
It is often difficult for system integrators to properly capture
the manufacturer’s requirements for an automated production
system. Sometimes, this is because a minimal specification
is supplied and essential information has to be coaxed out
of the manufacturer. At the other extreme, the enquiry consists
of two pages of technical specifications hidden within a
forest of commercial, contractual and general specifications,
which confuse the assessment of the requirements. >
Estimating
volumes
When considering an automated production process, it can
be difficult to estimate peak volumes. This is particularly
the case with a new product start-up when the marketing
data is variable. The techniques used for automated assembly
may be considerably different for manufacturing 1 part/min
on a single day shift compared with 1 part/s in a 24/7 regime.
Although difficult to assess, it is essential to have a
clear goal related to production volumes.
Identifying
basic physical operations
A system integrator needs to quickly gain an overall understanding
of the production process to ensure that it matches the
requirements. The following allows a swift response from
a potential supplier:
- A clear definition of the required assembly process
actions, preferably in diagrammatic form
- The allowed time to produce one part, for example,3/s
or 1/min.
- A completed assembly drawing or sketch.
- Component drawings with tolerances, if possible.
- A description of the method of presentation of each
component part to the system, for example, loose in a
box, on a conveyor, pumped or in a tray.
- Details of how the finished assemblies are to be presented
or packaged.
Requirements
for product verification
Next the requirements for product identification and verification
can be evaluated. The extent of work in this area will depend
on the cleanliness classification and validation requirements
of the production environment. Some processes do not require
verification of component parts as they enter the automated
system. Most subcomponents that carry a drug must be uniquely
identified and this must be recorded as the unit enters
the process. More often today, parts not containing drugs
must be checked as being present using Poka Yoke techniques.Poka
Yoke is Japanese for mistake proofing that involves 100%
automatic sensing of all components individually and together
to check the assembly.
A clear description of how the parts can be identified
and how the information is to be logged or verified is essential
to the design of the control elements of the automated system.
Automated processes are moving to 100% traceability of the
finished parts, therefore, labeling and data-storage requirements
need to be defined and communicated to the system integrator.
The control information specifically relevant to data handling
and verification will require knowledge of automated manufacturing
practices, GAMP 4,and the requirements of the Food and Drug
Administration’s Title 21 Code of Federal Regulations,
Part 11.
The
search for the right solution
A considerable investment in time is required to properly
understand the specific requirements and to formulate the
most suitable solution.Even with a clear route to communication
between the system integrator and the manufacturer, this
can run into many months of work for both sides just to
be able to determine the correct solution.Before a dialogue
begins, it is important that the manufacturer satisfies
himself that the potential supplier of the equipment is
capable of working to the required standards.Quality systems
standards such as ISO 9001/2000 and quality system requirements,QS
9000,are useful benchmarks for selecting system integrators
with experience in industries outside the medical manufacturing
industry.
Scope
of project expertise
When sourcing an integrated system, manufacturers may also
wish to investigate the extent to which the system integrator
performs the separate aspects of design,manufacture and
assembly in relation to the mechanical,electrical and software/control
aspects of the project. Most manufacturers would like all
of these elements to be directly performed by permanent
staff within the system integrator’s company to ensure
the timely completion and proper support of the machine
or system once it is in service. Some system integrators
subcontract major elements of software,control panel wiring
or manufactured parts.In addition, a supplier must be able
to support the system from concept,through manufacture,
assembly,capability/commissioning and into production.
Additonal
assistance
There is no one single route to selecting the correct system.Selection
must be on a case-by-case basis,matching the requirements
of the assembly system.In the future,there may be some assistance
in assembly system design and specification. There are currently
two research programmes in this area.The first is a European
Union thematic programme called Assembly-Net,
which is a discussion forum on assembly system design,manufacture
and use. The second is a project under the Eureka Factory
mechanism called E-Race that is just about to start. E-Race
is attempting to develop an interactive website for requirements
capture and design of flexible assembly systems
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