Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
Details of the research and results that has allowed a pharmaceutical serialization company and CMO to confidently conclude that there is no ink migration of inks through the walls of the HDPE bottles.
Innovative companies are now applying industry-specific Smart Manufacturing solutions to reduce time to value and improve efficiency and asset utilization while ensuring product and data integrity, regulatory compliance and safety.
R+D Custom Automation partners with Domino to brainstorm tailored coding solutions for each challenge created by the development of their client’s custom machines for the life sciences industries.
In November of 2013, the Federal government in the United States passed the Drug Quality and Security Act (DQSA) to create a national pharmaceutical serialization and track & trace regulation. This mandates serialized coding on primary and secondary pharmaceutical packaging beginning in 2017, and supersedes all state mandates (including California e-pedigree). Global traceability initiatives, such as the DQSA, are designed to hinder the production and distribution of life-threatening imitation or counterfeit pharmaceuticals. These initiatives can require identification and authenticity features on primary, secondary and tertiary packaging levels typically in the form of unique, non-predictive, serialized and machine readable codes. This level of product identification aims to impair the ability of counterfeiters to successfully replicate pharmaceutical products and packaging.
This robust and flexible machine delivers high resolution print messages and multiple line codes in even the harshest environments. Its tough and stackable cabinet is made from marine grade stainless steel which is not only dust tight but can withstand powerful water blasting during heavy duty cleaning. It's an innovative printer that, in every sense, truly takes some beating. The highest quality of print is also assured, allowing large amounts of data for high speed, rapid throughput printing. And higher quality codes are optimised for Machine Readable Codes (MRC) and Optical Character Recognition (OCR) systems helping to reduce rejects.
Domino has developed scribing laser coders that can print text, graphics and variable data onto a variety of substrates including plastic, glass, paper and cartons. As there are no inks or fluids used, laser systems are environmentally friendly and very cost-efficient systems for your coding requirements.
Domino supplies a comprehensive range of fluids and spares consumables for use in the full range of Domino coders.
The G-Series range of Thermal Ink Jet Printers use a HP Type 45A cartridge as the fundamental print engine ideal for pharmaceutical packaging.
The D-Series lasers offer a power range of 10W, 30W and 60W lasers to fit all your coding needs for a wide variety of materials, from low to high speed applications, basic to complex codes.
As compared to IV route, ODT can provide a convenient oral route of administration for proteins, peptides and vaccines. Join experts from Catalent for an overview of the challenges and opportunities in using ODT technology as a patient-centric drug delivery tool and get updates on the new developments in ODT technology including delivery of peptides and vaccines.
With transformational changes in biologics, there are increasingly newer formats of new biologic drugs including bispecific antibodies, antibody drug conjugates and antibody-peptide fusion proteins.
The complex structure of Biologics, the nature of the interactions with their partners, require accurate modelling method to predict their physicochemical properties.
Recent US and EU serialization mandates have introduced the GS1 DataMatrix barcode symbology into a much wider role in the pharmaceutical supply chain. While linear barcodes have served as identifiers for SKU- and lot-specific information, the more compact GS1 DataMatrix is now being used as the designated carrier for the greater amounts of data needed to authenticate and track each bottle and carton of prescription drug product. As the role of the DataMatrix has expanded, so has the need to read it consistently and reliably throughout the supply chain.
