Client Overview: Two top pharmaceutical companies and two major CMOs producing billions of doses of vaccines and other injectable products

Client Challenge:

When inspecting and counting of trays is a manual process, it can result in significant time and cost saving losses such as:

Quality, compliance and reporting issues due to human errors
Low throughput, oftentimes requiring 2x labor coverage, due to manual counting
Employee safety and satisfaction concerns resulting from repetitive motion, eye strain and needle poke

Solution:

After careful analysis of various client environments, Verista has developed solutions that directly improve the speed, accuracy and compliance of these manufacturing operations with the utmost importance placed on getting safe and quality products to market as quickly as possible. The Verista COUNTQ® system is an automated, high-resolution vision inspection solution that manages count reconciliation of tray loaded injectables (vials, syringes and ampoules).

To meet our clients' constantly changing product mix, the system allows for auto adjustment of the camera and light mechanism to seamlessly accommodate for variations in product height and tray type. Furthermore, the solution incorporates sophisticated inspection, optional deep learning capabilities and methods which are needed to achieve reliable results that standard machine vision can't attain for difficult-to-inspect formats (e.g., ampoules, needles). The systems can support an unlimited number of ‘recipes' to ensure compatibility with multiple product and tray types.

Number of Installations:

Top 5 Pharma implemented 9 COUNTQ systems, across 3 sites, analyzing billions of doses
Top 25 Pharmas implemented multiple COUNTQ systems
Top 5 CMO's implemented 10 COUNTQ systems

System Capacity:

1 tray, 950 ampoules or more, every 15 seconds
Supports standard fill line capacity of 300 vials per minute
100 million vials per year can be accommodated with one machine

Client Benefits:

21 CFR Part 11 compliant for comprehensive audit trail
Specification criteria can be set to a known (accept or reject based on a set value) or unknown count (report the number of products in the tray)
HMI (Human Machine Interface) images clearly indicate acceptance and reject counts to the operator
Automatic generation of lot and batch reports
Built-in security with data stored locally in the machine with un-alterable records
Option for Data Historian Connectivity and integration with MES

Results:

All clients have expanded their use and quantities of COUNTQ systems in their operations.
Improved accuracy and quality in tray counting and reconciliation
Significantly higher throughput
Reduced labor costs, risk and improved worker happiness due to fewer repetitive and hazardous tasks
Secure, configurable tray and batch reporting with complete audit trail and image collection capability
Unmodifiable records that meet all 21 CFR Part 11 requirements and helps identify product shrinkage