Medical Device and Pharmaceutical companies are subjected to various regulations national and international. Along with these regulations companies need to be aware of the increasing threat of counterfeit and misbranded products which cost the US Pharmaceutical industry an estimated 75 billion in 2010.
As the FDA (food and drug administration) amendments act of 2007 is edging closer, manufactures must implement a product mix avoidance standardisation across their supply chain.
Product mix avoidance is the tracking and tracing, authentication and data capture of pharmaceutical products across the supply chain. It’s clear that if pharmaceutical companies wait to implement a product mix avoidance solution across their supply chain there will be a resource crunch over the next few years so why are you waiting? Product mix avoidance is an opportunity to protect your customers, defend your products and improve your supply chain.
By implementing this solution you will be able to identify vital information such as serial numbers, expiration dates and will have the following benefits for your organisation:
- Recalls can be done much easier
- Been able to monitor product returns properly
- Serialisation counteracts misbranded and counterfeit recalls
Medical Device Companies
Mandated by congress in the FDA (food and drug administration) amendment act of 2007 stated that a product identifier should be applied to all medical device manufactures that export its devices to the US Market. The product should have a human and machine readable code these codes will uniquely identify the product. The UDI (unique device identifier) is a unique numeric or alphanumeric code which consists of two parts. The device identifier which recognises the specific version or model of a device. The production identifier which identifies vital production information such as lot/batch number, serial number, expiration date and manufacturing date. The dates with these regulation manufactures must comply with are as following:
- 2014 - 24 September. All class III these usually sustain or support life, are implanted or present potential unreasonable risk of illness or injury. Examples of class III devices include pacemakers and breast implants.
- 2016 - 24 September. All class II devices which include powered wheelchairs and some pregnancy tests. Most medical devices are class II as 43% of products fall under this category.
- 2018 - 24 September. All class I devices which are the least harmful devices to the user, these include enema kits and elastic bandages.
For more information on UDI you can down our brochure.
Track and Locate
From the moment raw materials are received, to the moment finished goods are shipped a track and locate solution will ensure fully traceability is achieved across your supply chain. Organisations that implement a track and locate solution help them cut costs, cut waste, automate critical manufacturing processes, monitor quality and increase productivity by fully serialisation products across the supply chain. By implementing a fully track and locate you will be able to:
- Improve data collection and reporting
- Improve efficiency across your supply chain
- The ability to check your raw materials usage which means you will be able to cut down on your expenses
- Keep ahead of the game with current and future legislation
Inspection Systems is the technology to replace or compliment the manual inspection and measurement process through sophisticated digital camera and image processing technology. For 1D and 2D barcodes to be read efficiently inspection systems need to be integrated into the production line which allow for accurate processing in a wide range of applications.
Inspection systems are extremely beneficial in the pharmaceutical and medical device industry as they have over 99.9% accurate rate. This means that sample testing can be replaced with 100% product testing allowing quality to standards to increase dramatically.
The inspection system reads 1D and 2D barcodes which verifies key information such as:
- The name of the product
- Serial Number
- Complete shipping information
- The expiration dates and the lot/batch number