Keep it clean
24 Feb 2020
The pharmaceutical, biotechnology and life sciences sectors are some of the most exacting in terms of extremely high levels of cleanliness and hygiene, together with the need for strict regulatory compliance. With these non-negotiables in mind, British Fluid Power Association members Camozzi Automation and Freudenberg provide guidance on what type of equipment and service provision companies operating within these sectors should look for from their pneumatic and electro-mechanical solutions providers of choice.
Pneumatics technology is widely deployed in many branches of industry, including construction, transportation, dentistry, mining and robotics, offering a number of business and operational advantages such as price-competitiveness, safety, ease of operation and a high level of control and flexibility when designing and building customised systems and machinery. Pneumatics is also recognised for its cleanliness and this is one of the reasons it is widely deployed within the pharmaceutical, biotechnology and life sciences sectors. These sectors are some of the most highly regulated in the world, and understandably so when people’s health and wellbeing depends on the safety and efficacy of the commercially available products they produce. Indeed, some of the most stringent standards in any industry are applied within these sectors; including DFA and GMP.
The contamination issue
Any technology used within this industrial space needs to be thoroughly proven to be free from a risk of unacceptable levels of contamination, and, in this regard, pneumatics can fit the bill perfectly.
Within pharmaceutical, biotech and life sciences, pneumatics solutions comprise a wide range of pneumatic and electric components for automation. This include everything from pneumatic actuators, valves/solenoid valves, air filter regulators and vacuum components, to servo motors, axes, cylinders, drives and components; all able to be controlled precisely by regulators and proportional valves. As Adrian Farnham, Managing Director of Camozzi Automation explains, proven electro-pneumatic equipment can offer all the speed and precision in positioning required for this industry. “Together with auxiliary motors and drives, electromechanical equipment such as cylinders and axes can help to optimise every movement with the performance required by each specific application,” he says. “With the help of electro-pneumatic technology, products can be combined into various configurations providing users with the utmost flexibility.”
The right solution
From a specification perspective, Mark Thompson, Technical Manager of Camozzi Automation, adds to Farnham’s synopsis, in recommending the use of highly intuitive configuration software that is capable of identifying the ideal solution for the customer, based on the specific requirements of the application in terms of load, speed, and acceleration.
Thompson also believes it is important for any solutions provider within this space to take a multi-technology approach; being able to analyse each individual application and develop solutions based on selecting the most appropriate pneumatic, electric or proportional technology. “On the part of the solutions provider, this analysis should be built on proven knowhow in product and technology specifications, and a thorough understanding of the functional characteristics of the specific applications,” he stresses.
For the control of actuation and the management of different types of fluids within the pharmaceutical, biotechnology and life sciences arena, Thompson points out that equipment such as linear actuators and grippers, valves and solenoid valves, plus components for air treatment, connection elements, and vacuum systems, are invaluable.
Complexity and innovation
Thompson comments that ongoing research and development in mechatronic solutions has led to the integration of sensors and diagnostic systems that are capable of processing information on the operating parameters of the system. With specific regard to Camozzi Automation’s own technologies supplied to the pharmaceutical, biotechnology and life sciences sectors, Thompson explains that the C Fluid Control division of the company was created to respond to the needs of an ever more complex and innovative market. “It is important for the solutions supplier to have the ability to combine experience in the design and mechanical processing of components for the fluid power sector with electronic and digital expertise, and in the selection and machining of both metallic and polymeric materials,” he says.
Farnham summarises, that the combination of fluid dynamic components and technologically advanced equipment enables leading companies within the electro-pneumatics marketplace to develop customised solutions for manufacturers of analytical and diagnostic instruments, including everything from clinical diagnostics, molecular diagnostics, clinical chemistry, hematology, electrophoresis, immunology, pathogen detection, liquid chromatography, drug discovery and DNA/RNA synthesis.
In order to help to keep equipment such as actuators operating at the correct working pressure and speed and temperature, seals are a critical component. Moreover, within the pharmaceutical, biotechnology and life sciences sectors seals need to be proven to be highly hygienic. Wulf Geiselhart, Technical Service & Innovation at Freudenberg Sealing Technologies, explains that the bar has been set especially high for pharmaceuticals when it comes to cleanliness and hygiene. “This applies to the production of drugs, in vivo diagnostics, vaccines and enzymes in equal measure, as well as to the preparation of products using blood fractionation – strict legal guidelines and purity requirements are always in force,” he says. Just some of the suitable sealing-related solutions for the pharmaceutical, biotechnology and life sciences sectors include dynamic seals such as piston rings and guide rings, while static seals fit for purpose include clamp seals, O-rings and flat gaskets.
Wulf Geiselhart adds that seals are in direct contact with a wide variety of partly aggressive media at fluctuating temperatures and pressures. “As a result, apart from their primary sealing function, they must also be completely free of hazards and side effects,” points out. “For one thing, they must unfailingly assure tightness and thus prevent process changes or product contamination. For another, they must not impair any active agents through interactions or the transfer of sealing components.”
For the highly sensitive aseptic field, Freudenberg Sealing Technologies has developed special USP Class VI-tested and EHEDG-compliant sealing solutions that are suited for contact with high purity water or ultrapure steam. The company’s seals are able to withstand CIP/SIP cleaning processes using aggressive cleaning media without difficulty and, when necessary, they have a dead-space-free design.
To assess any possible interactions with pharmaceutical products, Freudenberg Sealing Technologies has conducted extractables studies on selected sealing materials. These provide information about which ingredients and how many of them are, under certain conditions, migrating from the seal into the product. Wulf Geiselhart explains that this plays an important role in especially hygienic applications with high purity requirements. “With this in mind, we have developed several EPDM materials, as e.g. 70 EPDM 291, that are suited for highly sensitive processes. Furthermore, our fluorinated material family Fluoroprene XP even improves on these results.” He also points out it is critical that any seals used within the pharmaceutical, biotech and life sciences must meet with international industry approvals.
Meeting the challenge
Chris Buxton, CEO of the British Fluid Power Association (BFPA), concluded: “Pneumatics and related electro-mechanical equipment is widely recognised as a compatible technology sphere for deployment within the highly discerning environments of pharmaceutical, biotechnology and life sciences. However, in addition to the proven suitability of this equipment lies the need for the solutions providers themselves to fully embrace the requirements of these sectors from a customisation, cleanliness, service & support and health & safety perspective, as well as being focused on continuous development and innovation in order to constantly push the envelope of greater efficiency and reliability.”