Quality assurance for medical device manufacturers.

The maXYmos TL ML, from Kistler, is the first process monitoring system to meet the strict FDA and MDR regulatory requirements for quality assurance in the medtech sector. The new monitoring system can deliver 100 per cent testing; a critical requirement for manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced.

The new maXYmos TL ML, based on the tried-and-tested maXYmos system, can be easily qualified and validated for integration into existing quality management systems.

Process monitoring systems play an increasingly important part in quality assurance on automated production lines. Medical device manufacturers must demonstrate that their products meet the requirements for safety and quality and provide proof of the reliability and precision of quality assurance monitoring not only throughout their own manufacturing process but also that of their suppliers.

In extreme cases, inadequate quality assurance, during the production of medical devices, can cause injury or even loss of life. Companies that place medical devices on the market are fully liable in the event that their products fail to function accurately and consistently. This is partly why the industry is subject to such strict regulation. Producers of medical devices as well as plant and machinery manufacturers operating in the medtech and pharmaceutical sectors are confronted with huge challenges, especially when it comes to integrating process monitoring systems into automated production and packing processes.


Kistler has developed this new solution on the basis of its maXYmos TL (Top Level) well proven system. Like all the systems in the maXYmos family, maXYmos TL visualizes process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated directly into the production line to monitor and evaluate the quality of every step in the manufacturing process on the basis of a curve. With the help of evaluation objects (EOs), users can adapt the curve evaluation to the specific monitoring task. For instance, the tolerances defined in the process validation can be used for this purpose. Based on this specification, the system then decides whether each workpiece is good or bad.

The functions integrated in maXYmos TL ML comply with the regulatory requirements for applications in the medtech industry. The system hardware also meets the specific requirements for measurement equipment that apply in the medtech industry, including:

• Designed to accommodate exceptionally small measuring ranges (force-displacement monitoring, torque sensor technology) • Integrated user management compliant with FDA regulatory requirements • Audit trail of all changes to testing processes, with time and user indexing for end-to-end traceability of each individual product • Optional blocking of ports for secure integration into the customer's data structure • Direct printer connection so that test records can be documented as hard copies

The new maXYmos TL ML process monitoring system from Kistler gives producers of medical devices, as well as machinery and plant manufacturers operating in the medtech and pharmaceutical sectors, a much easier solution to the validation of their production processes. With 100 percent inspection of each step in the manufacturing process, the need for mandatory process validation in production can be completely eliminated.

Qualification of the production equipment is the first requirement for proof of the system's safety. For this purpose, Kistler supplies ready-to-use checklists for Installation Qualification (IQ) and Operational Qualification (OQ). An in-plant calibration can then be performed to validate the measurement system at any time – a service that Kistler offers for its customers throughout the world. This also makes requalification of assembly plants much simpler, because the entire measuring chain is calibrated. The key benefit to manufacturers is that they can bring their product developments and innovations to market much more quickly giving them the competitive edge that is such a critical factor in this industry.

The maXYmos TL ML system supports OPC UA, so that it can be easily connected to machine controls and communicate with higher-level control and management systems.

#Kistler #Medical 

Major doubts revealed about requirements for serialization!

More than one third (40 per cent) of pharmaceutical industry professionals are not confident that they will meet serialization deadlines in the US and Europe, according to new industry research.

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As the FDA has announced plans to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US to November 2018, the research, conducted by SEA Vision and  Zenith Technologies, gives further evidence for the need for additional time both in the US and Europe.

Just 18 per cent of those that took part in the survey are ‘extremely confident’ that they will meet impending track and trace deadlines, including the US DSCSA and the European Falsified Medicines Directive (FMD).

Highlighting a major cause of the lack of preparedness, 40 per cent of industry professionals admit that they are not clear what the global requirements for serialization are.

Despite the lack of understanding, the majority (38%) of companies will rely on an in-house team to handle the entire implementation. One third will use an implementation partner and 20 per cent will rely on their software and hardware providers for the required support and expertise.

Commenting on the research findings, Carlos Machado, serialization director at SEA Vision US, said: “Clearly the industry is going through a challenging period and there is nervousness around whether the supply chain will be ready for compliance deadlines in the US and Europe.

“The delay of the active enforcement of the DSCSA should not be viewed as a reason to be complacent, but instead the chance for small and mid-sized manufacturers that are behind in their serialization journey to get their preparations back on track.

“Just 43 per cent of those companies surveyed are already supplying serialized products to other markets where regulations are in place, so for many, the DSCSA and the FMD are steps into the unknown. As a result, we believe that reliance on implementation partners will increase and this brings about new challenges as demand may surpass capacity as the deadlines draw closer.”

• In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

@SEA_Vision  @ZenithIre  #PAuto 

Dangerous underestimation of urgency in meeting drug regulations.

New industry research reveals that more than one third (36 per cent) of pharmaceutical manufacturers and contract packagers are not currently preparing for global serialization requirements, despite impending deadlines.

The research, conducted by serialization system provider SEA Vision and life science technology firm Zenith Technologies, highlights an urgent need for companies to turn their attention to meeting the demands of the US Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (FMD).

Out of those companies that are not preparing for the new regulations, around half (51 per cent) say it is because they don’t currently have enough internal resource to devote to serialization, while 15 per cent believe it is too early to begin preparations.

Commenting on the research, Carlos Machado, serialization director at SEA Vision US, said: “Our research has confirmed that many companies are under-estimating the enormity of the task at hand. Preparing for serialization is a complex process that is so much more than simply integrating new technology on a packaging line. Instead, it should be a company-wide initiative, involving all corners of an organisation and the wider pharmaceutical supply chain.

“Those companies that delay their preparations risk production downtime and loss of business in key markets.”

For 56 per cent of those that have begun their serialization journey, compliance is the only goal of their serialization project at this stage. Just 44 per cent intend to use the process to achieve wider business benefits.

Carlos continued: “While serialization presents a number of challenges, it also creates an opportunity to review business processes and improve productivity. Those companies that embrace the changes and make preparing for the DSCSA and the FMD a priority, have a real opportunity to differentiate their offering, and it is our goal to support this process.”

In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

The collaboration brings together Italian-based SEA Vision’s serialization system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.

@SEA_Vision  @ZenithIre  #PAuto #Pharma

Pharma & Biopharm experts to discuss MES.

Following an invitation of Werum IT Solutions America, experts of leading pharmaceutical and biopharmaceutical companies will meet at the 14th North American PAS-X User Group Meeting on May 12th and 13th 2016 in NJ USA.

The MES user conference is the most important annual meeting of PAS-X users in the U.S. and of great value to all participants. “Leading industry experts are discussing the latest trends and challenges facing the FDA regulated industry,” states Benjamin Pieritz, Senior Vice President Operations of Werum IT Solutions America, Inc. “PAS-X users present their best-practice MES implementations and benefit from exchanging experiences with their peers.”

With PAS-X 3.1.8, Werum will demonstrate the latest version of its market-leading PAS-X Manufacturing Execution System for the pharmaceutical and biopharmaceutical industries. PAS-X 3.1.8 unites best in class MES features on latest technology platforms and addresses current trends in pharmaceutical manufacturing. Werum’s customers also have the opportunity to register for PAS-X classes during which Werum consultants explain how to leverage existing PAS-X features and how to incorporate new features into the customer’s processes.

 @Werum #USA

Hygienic level measurement!

Siemens has developed a new hygienic encapsulated antenna with a measuring range of up to 20 meters for the Sitrans LR250 radar level transmitter. Its lens is made of TFM PTFE (next- generation polytetrafluoroethylene), a special feature that makes the antenna fit for use in hygiene-sensitive applications. The user benefits from minimal maintenance and easy cleaning.

Sitrans LR 250

The encapsulated antenna comes with a TFM 1600 PTFE lens which has been approved by the U.S. Food and Drug Administration (FDA) and certified in accordance with the U.S. Pharmacopeial Convention (USP) Class VI. It also complies with the 3-A sanitary standard and has been approved by the European Hygienic Engineering & Design Group (EHEDG) for use in hygienic applications.

A selection of 17 standard hygienic process connections is available for linking the antenna with the Sitrans LR250 radar level transmitter, making it fit for use in the pharmaceutical, food and beverage industries. Users will appreciate the antenna’s minimal maintenance requirement and ease of cleaning as the flushmounted lens antenna does not need to be removed for clean-in-place cycles.

Sitrans LR250 for use in the pharmaceutical, food and beverage industries

Recorders comply with FDA 21 CFR Part 11!

Yokogawa has announced release 2 of the SMARTDAC+(R) GX and GP series paperless recorders. With these new versions, which are to be released next month (April 2014), all GX series panel-mounted recorders and GP series portable recorders will comply with the FDA 21 CFR Part 11 guidelines, and accommodate an increased number of inputs. In addition, a new graphics display function is available as an option.

Development background
Recorders are used on production lines and by R&D personnel in various industries to acquire, display, and record data such as temperature, voltage, current, flow rate, and pressure. Today, Yokogawa is one of the world’s top suppliers of recorders.

A shift from paper recording systems to digital recording systems is currently underway, and these digital devices are often used on networks. There is also an increased demand for touch-panel user interfaces like those found on mobile devices and the capability to centrally handle a larger number of inputs from devices spread out over a wide area. To accommodate such needs, Yokogawa announced the release of its GX and GP series recorders in October 2012.

With the functions that are included in release 2, the GX and GP series recorders now comply with the FDA 21 CFR Part 11 guidelines that are widely followed within the pharmaceutical industry, are capable of handling an even larger number of device inputs, and are easier to use.

Enhancements

1. Compliance with FDA 21 CFR Part 11 - In response to requests from US pharmaceutical companies, the FDA 21 CFR Part 11 guidelines were issued in 1997. These stipulate what is required for electronic records and electronic signatures to have the same validity as paper-based records and signatures. With release 2, the GX and GP series recorders now comply with the FDA guidelines on the use of electronic records and electronic signatures in production operations. It is expected that the Yokogawa recorders will also comply with similar regulations that have been established in countries other than the United States.
2. Accommodation for up to 450 inputs - With release 2, the GX and GP series recorders can now be used with up to six expansion units, each of which can accommodate up to 60 inputs. Including direct inputs, this gives each recorder the ability to handle a combined total of up to 450 inputs. The cables connecting the expansion units and the recorders can be up to 100 metres in length, which allows the expansion units to be installed closer to sensors and thereby reduces cabling costs.
3. Custom-designed graphics display function (optional) - A new display function is now available that allows users to supplement the recorder’s standard figure and chart templates by uploading graphics that can be created using a separate image editing program. For example, a graphic of a water tank or some other facility can be prepared that can be displayed together with temperature and pressure values on the recorder screen. With this function, a recorder can also function as a process display unit or console panel, in addition to its main data recording function.

Major markets for the GX series include production plants in industries such as iron and steel, petrochemicals, chemicals, pulp and paper, food, pharmaceuticals, water supply and wastewater treatment, and electrical equipment and electronics. For the GP series, they include R&D units in industries such as consumer electronics, automobiles, semiconductors, and new energy; universities; and research institutes

Applications include acquiring, displaying, and logging data such as temperature, voltage, current, flow rate, and pressure.

Future product development
SMARTDAC+ stands for smart data acquisition and control. In addition to the GX series and GP series paperless recorders, the introduction of other products series as well as input modules for a variety of signal sources and output modules for control applications is planned for the SMARTDAC+ system, thereby supporting a wide range of data-gathering control applications such as production process monitoring and performance evaluation. As a leading company in the recorder market, Yokogawa will continue to respond to a wide variety of needs with the release of new products for the SMARTDAC+ system.

Safe sensors in food!

Headwall Photonics has announced that their CEO David Bannon recently met with USDA Deputy Secretary Kathleen Merrigan to discuss Headwall sensor technology developed through close collaboration with the USDA Agricultural Research Service organisation.

The following Headwall Hyperspec® sensors are COTS products and are available as optimized sensors for the following spectral regions:
UV 250 - 600nm
VNIR 380 - 1000nm
Extended VNIR 550 - 1700nm
NIR 900 - 1700nm
SWIR 950 - 2500nm

The success of recent USDA and FDA initiatives such as the Food Safety Modernisation Act and expansion of the HACCP Based Inspection Models Project (HIMP) are in part dependent upon the incorporation of new techniques, protocols, and instrumentation that are consistent with food safety regulations and enhanced food quality objectives and provide US food producers with increased competitive capabilities.

For a number of years, Headwall Photonics has worked closely with researchers and scientists at the USDA Agricultural Research Service, the agency's chief scientific research organisation, to develop spectral imaging instruments for high speed, in-line inspection of food and agriculture products. These spectral vision systems utilise a specialised processing algorithm that is tailored to the specific product or agricultural inspection algorithm.

"Through ongoing collaboration with USDA researchers, Headwall continues to develop cost-effective, compelling spectral solutions that support improvements in food safety inspection and food quality while meeting the need of food processors for high throughput inspection," offered David Bannon, CEO of Headwall Photonics. "Our hyperspectral sensor platform has been specifically designed for these critical applications."

Headwall's hyperspectral in-line imaging instruments represent a critical inspection technology that allows food processors and agricultural researchers to identify product characteristics within the field of view of the sensor based on the sample's chemical 'fingerprint' or spectral signature rather than relying solely on visual appearance. Based on a patented sensor design, Headwall's Hyperspec Inspector™ sensors are specifically designed for high spectral and spatial imaging in very harsh operating environments such as required within food processing centers. Headwall's hyperspectral imaging platforms have been optimized for reliable, cost-effective performance based on years of deployment within military and defense organizations.

'Clean Design' pneumatic actuators provide cost-effective solution for food industry automation

Round and guided cylinders use FDA-approved lubricants and seals

Festo has launched a new generation of pneumatic actuators designed to provide a cost-effective alternative to specialist high-end components for the food and beverage industries. The actuators employ 'Clean Design' principles to help minimise contamination risk, and are ideal for use in aggressive environments where frequent wash-down procedures are implemented. The first products in this new range include corrosion-resistant round and guided cylinders that use FDA (U.S. Food and Drug Administration) approved seals and USDA (U.S. Department of Agriculture) approved H1 food-grade lubricants.

The new Clean Design cylinders are intended to help OEMs building food safe automation overcome the apparent dichotomy between expensive custom components and non standards compliant off-the-shelf equipment. Festo believes that there is a market for automation components that steer a clear middle road, produced using a combination of standard parts, specialist materials and the latest fabrication technologies.

Their new CRDSNU round cylinders and DGRF guided cylinders are the first products to embody these principles, following extensive research into surface friction, lubrication and wear, materials analysis and computer-optimised design. Both product families are characterised by very smooth, corrosion-resistant body profiles that are free from protrusions, to facilitate efficient wash-down and removal of any bacterial contamination.

The CRDSNU stainless steel round cylinder is available in eight ISO 6432 compliant sizes spanning stroke lengths from 1 to 500 mm. The cylinder uses Festo's patented PPS self-adjusting pneumatic cushioning technology, which automatically adapts to the prevailing load and speed conditions to provide optimum end-position cushioning. This technology offers maintenance-free operation, and has the additional advantage that by obviating the need for a manually-adjustable cushioning screw, it helps preserve the cylinder's clean wash-down lines and ensure optimum machine operation with minimal noise.

For applications that involve high torque moments, Festo has introduced the new DGRF guided cylinder, which features lateral piston rod support guides. These cylinders offer a choice of six different bore sizes from 20 to 63 mm, and are available with stroke lengths from 10 to 400 mm.

As standard, Festo's CRDSNU and DGRF cylinders are fitted with FDA-compliant lubricants and wiper seals, suitable for use in environments involving direct contact with food products. However, for particularly aggressive applications demanding frequent detergent-based wash-down, the cylinders are also optionally available with UHMWPE (ultra high molecular weight polyethylene) self-lubricating seals. These non-toxic seals combine high abrasion resistance with an exceptionally low coefficient of friction, which helps to ensure a long service life when 'dry-running' operations are encountered.