Pharma 4.0

 

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Lead the charge on the Pharma 4.0 Digital Transformation at your organization with Grantek. Pharma 4.0 refers to how the 4th Industrial Revolution will forever change Pharmaceutical and Life Sciences Manufacturing. Manufacturers in all sectors are tasked with improving and integrating operations to address the opportunities available with the Digital Transformation of operations. Pharmaceutical and Life Sciences Manufacturers have a unique opportunity to incorporate the technology behind The Industrial Internet of Things (IIoT) into their processes, allowing them to meet the changing reporting and compliance requirements in these highly regulated industries, while reducing operational costs.

IIoT

IIoT is the use of Internet of Things (IoT cloud) technologies in manufacturing. Also known as the Industrial Internet, IIoT incorporates machine learning and big data technology, harnessing the sensor data, machine-to-machine (M2M) communication and automation technologies that have existed in industrial settings for years. The driving philosophy behind IIoT is smart machines are better than humans at accurately, consistently capturing and communicating data. This data can enable companies to pick up on inefficiencies and problems sooner, saving time and money and supporting business intelligence efforts. In manufacturing specifically, IIoT holds great potential for quality control, sustainable and green practices, supply chain traceability and overall supply chain efficiency.

The IoT cloud offers the prospect of providing access to data and control of electronic devices from any available internet connection. IIoT provides the same exciting possibilities for industrial equipment and facilities. The addition of connected devices, such as environmental sensors, security systems, and sensors for remotely-located equipment, brings the added benefit of enhanced control and monitoring capabilities at a facility, but also increases network traffic and the effort required to manage the devices. Grantek has the expertise to help ensure your network continues to operate at optimal levels, without compromising security, as additional devices are added.

IIoT allows for flexible and robust data acquisition and system control. In keeping with our methodology and standardized process approach, Grantek has the expertise to develop secure connectivity solutions to your manufacturing challenges while addressing the complexity of IIoT integration. We use a vendor-agnostic approach to selecting sensors and controllers in order to determine optimum connectivity for reliability and data storage requirements. To realize the full benefit of IIoT, you need a partner who understands how to turn data into useful information. Grantek leverages off-the-shelf software to develop integration points, providing IIoT data output to ERP systems and presenting it in meaningful ways that create value in your enterprise.

Pharmaceutical

Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit, gray market and stolen product. Impending regulations aimed at protecting public health, intellectual property and national security will require pharmaceutical, medical device and consumer packaged-goods manufacturers to track and trace products across the supply chain.

With regards to medication specifically, in response to weaknesses in the regulation of the drug supply chain, the US Congress passed the Drug Quality and Security Act on November 21, 2013. Title II of the Act, the Drug Supply Chain Security Act, requires that manufacturers affix or imprint a product identifier to each package and homogeneous case (pharmaceutical serialization). Tracing your finished product back to API’s, compounds, and all upstream suppliers is critical – tracking downstream is equally important in the event of a recall.

Medical Devices

The FDA requires manufacturers to comply with the final rule establishing a unique device identifier (UDI) released in 2013. This rule was designed to adequately identify medical devices from manufacture throughout it’s useful life using a UDI as issued under a system operated by an FDA-accredited issuing agency. The UDI is to consist of two parts: a) a device identifier that identifies the manufacturer and its specific version or model and (b) a product identifier that identifies one or more of the following:

  • lot or batch number
  • device serial number
  • expiration date (if applicable)
  • manufacture date
  • The distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

How Grantek can help with Pharma 4.0

Grantek’s extensive experience in the pharmaceutical and medical devices industries, combined with our knowledge of FDA and Health Canada regulations provides us the unique capability of helping our customers successfully and safely comply with new regulations. We successfully integrate technologies and processes to allow our clients to implement their Pharma 4.0 Digital Transformation.

Grantek provides thought leadership on all aspects of Pharma 4.0 Digital Transformation. Grantek is an industry leader, providing consulting, design work and delivery in areas including: front-end design, development, implementation, commissioning, testing, and qualification of MES, LIMS, Historians, vision systems, barcode reader applications, and on-the-line integrated printer applications. Grantek converts data output from these systems into comprehensive reports to help manufacturers track ingredients and components as well as finished product, while maintaining serialization data for regulatory compliance.

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