Identify the project to determine the optimal packaging solution, customized to meet the needs of the client and consumer while adhering to regulatory requirements.
Conduct feasibility study; initial testing; and review of materials that are compliant to ISO, FDA, REACH and other regulations. Considerations are given to: security solutions, functional and complex performance of product, and innovative applications.
Establish timelines and ensure milestones are achieved: review samples and prototypes, establish initial production methodology, perform QC lab testing to validate recommended solutions, link critical client requirements to the product record within the ERP system.
Create proofs to ensure the accuracy of the label and packaging. Process may include ink drawdowns, 3D modeling and/or production press proofing.
Validate the product and application. Production samples may be provided for client testing.
Manufacture product in accordance with ISO 13485 standards. This includes:
- Regulatory compliance assistance and component verification testing (e.g. trace element analysis, performance and composition certification, etc.)
- Security controls best suited for the needs of the individual customer
- Line clearances, area segregation and individual product cages throughout the converting process
- 100% inline text verification when needed
- Backside consecutive numbering for label count reconciliation upon request
- Finished rolls with leaders and trailers as required and perfect roll tension to ensure smooth operation on application equipment
- Sealed and securely wrapped pallets of finished goods to support FDA/GS1 initiatives
- Full chain-of-custody within a secure production facility
Document controls for complete product traceability in line with cGMPs: full raw material and shipment chain-of-custody, first piece sign-off by internal PCM, Certificate of Compliance supplied with each shipment, final QC inspection and approval, product record finalized within ERP system.
A pharmaceutical manufacturer was exploring the possibility of a label redesign on an injectable product. Their goal was to provide another layer of protection to the administration protocol, without adversely affecting the label application process within their manufacturing facility.
Due to the size of the vessel, the pharmaceutical manufacturer was limited in the area available to highlight the required precautionary instructions for the drug. Additionally, the newly designed label needed to work within the specifications of the current application equipment at the factory level.
APPROACH AND SOLUTION
Through a number of application tests with various materials, adhesives and perforation configurations, Gintzler International proposed a highly visible label that was capable of covering the vial’s cap by incorporating an adhesive deadened area to the design. This approach allowed the pharmaceutical manufacturer to apply the required warnings related to the use and application of the drug, and also added an extra security feature.
To address their customer’s targeted production efficiencies, Gintzler employed a high-speed camera on their client’s labeling application line. The data gathered gave Gintzler the needed information to develop the proper adhesive capable of being applied at a high rate of speed without failure.
The label solution offered by Gintzler provided another level of security at the clinical level to ensure the correct prescription was being used, ultimately ensuring the well-being of patients. The pharmaceutical manufacturer was able to achieve their targeted run time utilizing the newly designed label without incurring added application expense.