Today, more than ever, it is imperative to deliver quality ensured pharmaceutical products to customers worldwide. Although quality assurance begins with the manufacturing process, it ends with packaging.
The technology surrounding the inspection and tracking of finished pharmaceutical components has rapidly changed in the past few years. These changes and challenges have pushed the expectations surrounding the ability to manage and control products in our industry. The advances in technology, along with increased expectations, impact how integrity testing and visual inspection processes are integrated within current and future packaging operation designs.
Integrity testing of all packaging mediums ensures quality packaging and safe products are delivered to your customers. Integrity testing equipment must be installed at various locations of the packaging process. Wilco is a leader in integrated Leak Detection equipment for established manufacturing processes. Leak testing equipment can be supplied for liquid filled, solid filled and flexible products. In addition, the use of their Head Space Analysis allows for non-destructive and fully automatic, 100% in-line measuring of oxygen contents, residual moisture, and absolute pressure in products. They also employ NIR (Near Infrared Spectroscopy) and X-Ray technology to meet the requirements of customers world-wide.
Integration of visual inspection equipment throughout the filling and packaging process also confirms that your product is safely packaged. The implementation of vision systems is not just limited to the end of a filling line. The need for vision systems within a filling machine, capping machine and packing line has increased over time. The team at Seidenader offers options for implementing the use of visions systems at the critical points of manufacturing. Seidenader develops high-tech solutions for the inspection of pharmaceutical containers for liquid and dry sterile products. For example, pharmaceutical products that are applied as injection or infusion can be inspected for particulate matter. Inspection systems detect moving and non-moving particles in liquids with the use of light extinction and light scattering methods. Seidenader provides both automatic and semi-automatic solutions, to effectively detect foreign particles, no matter your batch sizes or production rates. They also provide tablet inspection equipment to sort product by width and length. Oversized and undersized products are removed from the processing line to guarantee only acceptable Oral Solid Dose products reach your customer.
Product containers are subject to introduction of foreign materials until they are successfully sealed, including glass fragments or other materials used to seal the container. It is especially important to check for fragments in liquid and freeze-dried products. Brevetti CEA engineers and builds simple, well-built solutions focused on inspecting vials, ampoules, cartridges and syringes to ensure all foreign materials are detected and those units are removed from the supply chain. They customize lighting units to successfully inspect your product through reflection, absorption and/or polarization utilizing both intermittent and continuous motion technology.
The requirement to integrate and establish Serialization programs has also provided new challenges to pharmaceutical manufacturers. Considering the increasing threat of counterfeit, misbranded, adulterate and/or diverted prescription drugs, reliable track and trace procedures must be employed to ensure consumer safety. In theory, serialization is a straightforward process in which a unique identifying code is applied to each unit-level product. Codes are communicated along the packaging line to allow for aggregation. Aggregation applies the parent-child relationship between the unit-level product and cases and pallets in which they are shipped. This information is then relayed through the supply chain to the end user.
With the increasing demand of Serialization and many questions surrounding the upcoming regulations, manufacturers look to equipment vendors for expertise on when, where and how to implement serialization on their existing packaging lines. IMA Life facilitates the best approach for a phased, long-term, cost-effective, and sustainable program to suit your needs. They provide a variety of automatic labeling equipment for easy application in existing carton and bottle packaging lines. IMA offers small footprint options for existing lines where space constraints are a serious issue.
As manufacturers prepare to install new packaging lines for new or existing products, Serialization must be factored in to the overall design, cost and timeline. Manufacturers develop their serialization strategy based on regulations, including the proper unit dose required for serialized data and how far down the packaging line to aggregate products. Dividella executes projects globally integrating serialization technology into new parenteral packaging lines. They create a system which codes, verifies and tracks packages through the packaging process based on clients’ serialization strategy. In addition, they collect and maintain integrity of data through the supply chain.
Space limitations of new or existing lines must be considered when integrating the additional equipment required for serialization. OCS Checkweighers offers an integrated system to print, verify and inspect products with their Traceable Quality System (TQS) equipment, combing the functions of three separate pieces of equipment into one, utilizing one control software and interface. OCS is able to integrate third-party hardware and software specified by the client or provides a turnkey solution complete with cameras, hardware and software. Human readable text and 2D codes are gathered from the ERP infrastructure (i.e. SAP, Oracle) and printed on the unit level package. The code and text are verified by cameras. Inspection of the package is complete when the package passes over the weigh cell, verifying product is present and within weight tolerance.
Aggregation of the unit-level product allows for traceability when pharmaceuticals are distributed in shippers. It provides a parent-child relationship between the unit level package the shipper. Secure aggregation must be achieved and accomplished by creating physical aggregation prior to data aggregation. Products must be bundled, and then the barcodes are read and reported to the ERP System and printed on the shipper label. This approach provides certainty that the physical contents of the shipper match the information in the serialized database. Based on manufacturers’ processing rates fully automated and semi-automated equipment is available through Optel Vision. The semi-automatic aggregation station allows for manual packing of shippers and utilizes a single layer reading station which relays the information to a label printer. Labels are manually applied to the closed shipper after secure aggregation is complete. In the even RFID is used at the shipper level, Optel Vision offers an RFI Tunnel that identifies packages in a case and links the shipper serial number with the items enclosed.
Achieving accurate serialized data and aggregation hinges on the automated equipment to communicate with existing ERP systems. Installed Systech Citadel systems facilitate accurate data exchange and storage of serialization and aggregation data through the supply chain. Systech provides both software and hardware to achieve accurate serialization.
By employing these inspection technologies to new and existing packaging lines, manufacturers can guarantee products received by end users have been inspected for filling and packaging defects creating safer pharmaceuticals worldwide. To also provide security that patients receive authentic, non-counterfeit, unadulterated products as we enter the time where serialization becomes mandated, it is imperative to understand the technologies offered to achieve serialization and aggregation as they are interpreted implemented and by your company.
This article originally appeared in the 2014 INTERPHEX Technologies Tours supplement from PharmPro.