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Pharmaceutical Manufacturing and Packing Sourcer

Pioneering Device Production

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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