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Pharmaceutical Manufacturing and Packing Sourcer
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There are several innovations that
pharmaceutical manufacturers can consider in the development of drug
delivery systems, particularly in the design and production of
specialised component parts
Many people still imagine engineering as being oily, harsh, dirty and
completely divorced from the clean, sterile world of medicine and
pharmaceuticals. In reality, of course, this could not be further from
the truth as almost all medical equipment and devices consist of
engineered parts. Indeed, even plastic parts often have to be
engineered using injection moulding, pressure or vacuum forming, or
made using traditional engineering techniques, such as milling and
turning.
Furthermore, it is not only common components, such as chassis parts
for scanners or wheels on hospital trolleys, but also specialised parts
that come into contact with humans that are engineered. Everything from
syringes and surgical instruments, to parts that are even inside the
body such as vascular stents, undergo some sort of engineering process
in their manufacture. So when it comes to specialised engineering for
the pharmaceutical sector, the traditional perceptions do not represent
the reality. Indeed,modern manufacturing is clean, highly advanced and
automated, and works to the highest global standards, including Good
Manufacturing Practice (GMP).
Regulatory Forces
With the law behind it, GMP ensures that manufacturers of drugs and
medical devices take proactive steps to guarantee that their products
are safe and effective. In particular, GMP regulations address issues
including record keeping, qualifications, sanitation, cleanliness,
equipment verification, process validation and compliant handling,
enabling companies to minimise or completely eliminate the risk of
contamination and errors. Failure to comply with GMP regulations can
result in extremely serious consequences including recalls, batch
seizures, fines and even custodial sentences. Ultimately, this protects
consumers from purchasing products that are ineffective or even
dangerous.
Accordingly, when partnering with an engineering firm that works to GMP
regulations, pharmaceutical companies can receive quality assurance to
ensure that medicinal products are consistently produced, controlled to
quality standards appropriate for their intended use and those required
by the marketing authorisation or product specification.
Therefore, a good supplier of machined component parts should not only
work to GMP guidelines but should also be ISO 9001 approved, through
documenting and recording every process step. This is all carried out
electronically but makes the history of every part fully traceable down
to the very last detail, including which machine operator was working
on the part or when a turning tip was changed and inspected for use,
with this information being freely available to all of the company’s
customers. Just as importantly, cleanroom type facilities should be
established, which will see parts being cleaned and degreased in a
controlled environment.
Cold Forming
The use of cold forming allows manufacturers to produce high precision,
bespoke components for the pharmaceutical sector. In contrast with
conventional component manufacturing methods, precision cold forming
can be used to produce extremely high quality components, which have
superior mechanical characteristics and a better surface finish with
considerably less scrap. In many instances, component costs can be
reduced by up to 70 per cent, while lead times can be cut by a similar
amount.
Essentially, cold forming is the process of producing components at
low, usually ambient temperatures without removing any material, where
billets of advanced engineering metals, such as copper, brass,
aluminium or steel alloys are extruded under pressure in a specially
designed die set. A simple blank, which has been sawn or cropped from a
round bar or wire, or a cold headed preform, is placed within a die and
a punch is applied to the blank. As a result of the force, which can
typically be anything up to 2,000 tons, the blank then takes on the
form of the punch and the die.
There are a number of types of cold forming, ranging from forward and
backward extrusion through to freeflow. The type of component required
should be used to determine the method of cold forming that is most
suitable for the application. Through extrusion, drawing or coining, a
blank can be made into a wide range of components, segments and
assemblies.
Technology in Practice
Cold forming offers many advantages in the manufacture of metal
components. In particular, significant cost savings can be achieved by
reducing waste, particularly in present times where the price of raw
materials, such as copper, is at a premium. As cold forming eliminates
the need for machining or removing any metal from the blank, there is
virtually no waste which, when producing high volumes of component
parts, will lower operating costs considerably.
As it is performed at ambient temperatures, cold forming is a far
quicker process than more conventional options, allowing manufacturers
to achieve much shorter production processes. This in turn means that
components can be made to order extremely quickly, cutting lead times
and the need to store high volumes of spare parts onsite. Production
cycle times can be cut even further with multi-station machinery, which
can be particularly useful in large production runs.
Aside from tangible cost savings, cold forming makes for superior
quality products by plasticising metals along their grain boundaries
rather than cutting across, thus producing parts with extremely low
levels of stress deformation and high levels of mechanical integrity,
resulting in far greater performance and reliability. Furthermore, the
technology offers outstanding levels of definition, even on parts with
complex contours. Typically, dimensional tolerances should be within
plus or minus two microns, with the added benefit of extremely fine
surface finishes, which in many cases, require no further machining or
polishing.
Additionally, parts undergo work hardening during the cold forming
process, improving their machinability and durability. Work hardening
dislocates the structure of the metal in a way that prevents further
dislocations, resulting in a stronger component. As this increase in
strength is comparable to that of heat treating, it can be more
costeffective to cold work a weaker, less costly metal than to hot work
a more expensive one, particularly where a precision finish is
required.
The cold forming process also makes it possible to produce component
parts with a superior finish, both internally and on the surface.
Accurate internal profiles and complex external profiles are possible,
enabling precision parts to be manufactured that can have a significant
impact on the performance of the equipment in which they are used.
Furthermore, there is almost no limit to the shape, size or complexity
of the metal components that can be produced using cold forming. Simple
cold headed parts or highly complex cold formed and finished machined
components can be produced for a diverse range of applications.
In many cases, cold forming can be the most efficient and
cost-effective method for producing a wide range of metal components,
although, due to the relatively high setup costs, it is particularly
suited to large volumes. These costs can, however, be minimised by
outsourcing the production process to a specialist component
manufacturer that has the facilities already in place to cold form
bespoke components.
To give an example of cold forming being used to manufacture precision
components in the medical and pharmaceutical sector, consider a
recently developed needle free syringe, designed to relieve the
suffering of people with central nervous system (CNS) and pain
disorders. The product is a drug-device combination that enables the
needle free delivery of subcutaneous sumatriptan for the acute
treatment of migraines and cluster headaches. Manufacturing this
syringe requires intricate cold forming processes to achieve specially
engineered parts, including an aluminium chamber and steel ram, with a
highly accurate pressure and finish that would enable the drug to be
shot into the user’s body without the need for a needle. As a result,
medication can be administered quickly, simply and without anxiety. The
success of the design is partly due to the high quality mirror finish
on the inside of the piston, while the angles in the design also played
a crucial role in ensuring that the trigger mechanism worked
effectively.
Steel Manipulation
Another exciting new development is the potential to cold form in
stainless steel. This represents particular challenges due to the
hardness and unique mechanical properties of the metal; the difficulty
is that many of the punch and die sets used in cold forming are also
made from stainless steel, so they tended to collapse slightly when
first used. However, a complex tooling design is being developed to
allow for this controlled deformation. This latest innovation opens up
a world of new opportunities for the manufacture of precision parts in
the healthcare sectors, including surgical instruments and equipment.
Conclusion
In comparison to traditional methods for manufacturing metal
components, cold forming technology offers an extremely versatile and
cost-effective production method. Moreover, cold forming delivers
unrivalled levels of quality, accuracy and flexibility in the medical
and pharmaceutical sectors, as components are extremely strong and
lightweight, with superior surface finishes. Ultimately, this
production method allows companies to significantly improve the
efficacy of devices, while also boosting the profitability and
productivity of their operation.
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Mark Jennings is the Engineering Director for Dawson Shanahan Ltd. Mark joined the company, based in Potters Bar, in 2000 and has more than 30 years of cold-forming experience making components for several industry applications, including automotive, aerospace, medical, power switchgear and control. He has worked with materials such as copper, aluminium, steel and stainless steel. Combining engineering with production management, Mark has extensive experience of modern production techniques and quality control systems, including cGMP.
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